Learn From Others
This segment contains a directory of, and links to, publications related to aspects of the Medical Product Stability Function.
The authors provide findings of research we may not have the resources to undertake, or they have explored a complex process (application of a new guidance, new statistical analysis method, mapping a stability chamber, etc.) and save us from not-so-obvious pitfalls when we embark on the same or similar process.
Note that some of these materials reside in commercial collections and may require membership in that organization for full access.
Topic | Title | Publication | Authors | Date | Link |
|---|---|---|---|---|---|
| Accelerated Stability | Risk-Based Predictive Stability–An Industry Perspective | Pharmaceutical Technology | Helen Williams, Dennis Stephens, Megan McMahon, Elke Debie, Fenghe Qiu, Cherokee Hoaglund Hyzer, Lois Sechler, Rachel Orr, Debra Webb, Yan Wu, David Hahn | 5/2/2017 | http://www.pharmtech.com/risk-based-predictive-stability-industry-perspective |
| Accelerated Stability | An Introduction to the Accelerated Stability Assessment Program | American Pharmaceutical Review | Christian Rack | 8/15/2017 | http://www.americanpharmaceuticalreview.com/Featured-Articles/341253-An-Introduction-to-the-Accelerated-Stability-Assessment-Program-ASAP/ |
| Accelerated Stability | Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template | Pharmaceutical Technology 42(8):42–47 | Dennis Stephens, Helen Williams, Megan McMahon, Fenghe Qiu, Cherokee Hoaglund Hyzer, Elke Debie, Yan Wu, Hanlin Li, Jin Wang | 8/2/2018 | http://www.pharmtech.com/risk-based-predictive-stability-pharmaceutical-development-proposed-regulatory-template |
| Accelerated Stability | Utilization of risk-based predictive stability within regulatory submissions; industry’s experience | AAPS Open 6:1 | Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, Robert Bujalski, Fenghe Qiu, Yan Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer and Donnie Pulliam | 5/11/2020 | https://aapsopen.springeropen.com/articles/10.1186/s41120-020-00034-7 |
| Accelerated Stability | Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices | GoodReads | edited by Fenghe Qiu, Garry Scrivens | 5/16/2018 | https://www.goodreads.com/book/show/34640770-accelerated-predictive-stability-aps |
| Accelerated Stability | Risk-Based Predictive Stability: Feedback from IQ Working Group Regulatory Sub-Team | Sci of Stability Conference | Elke Debie | 8/14/2019 | https://iqconsortium.org/news/iq-consortium-lean-stability-and-risk-based-predictive-stability-working-gr |
| Accelerated Stability | Accelerated stability modeling for difficult cases: when nothing happens and when degradants degrade | Sci of Stability Conference | Kenneth Waterman | 8/14/2019 | https://freethinktech.com/wp-content/uploads/2019/10/Waterman.pdf |
| Accelerated Stability | Lean Stability Case Studies: IQ Lean Stability Working Group | Sci of Stability Conference | Susan Smith | 8/14/2019 | https://freethinktech.com/wp-content/uploads/2019/10/Smith.pdf |
| Accelerated Stability | Applying Arrhenius modeling to complex vaccines | Sci of Stability Conference | Els van Deventer-Troost | 8/14/2019 | |
| Accelerated Stability | Physical Stability of an Amorphous Spray Dried Dispersion | Sci of Stability Conference | Graeme Horne, | 8/14/2019 | |
| Audits/Inspections (new 2/2022) | Pharma’s remote audits are here to stay | Pharma Manufacturing | Jonathan Davies, | 12/16/2021 | https://www.pharmamanufacturing.com/articles/2021/pharmas-remote-audits-are-here-to-stay/?utm_medium=email&_hsmi=203152723&_hsenc=p2ANqtz--_PG4EJ9H0MIAWSlPG-PgGK84HmN0cZsmJBexCepgIQJh60vrWpA6E4sw4v8aAprhCrXlFvXxySbtZG7-kfmfrD1MDcQ&utm_content=203152723&utm_source=hs_email |
| Audits/Inspections | Auditing and Assessing The Quality Control Laboratory | IVT Jr GXP Compliance Vol 23 Issue 4 | Tim Sandle | 7/24/2019 | http://www.ivtnetwork.com/article/auditing-and-assessing-quality-control-laboratory |
| Audits/Inspections | Auditing Stability Programs | CfPA Webinar | John O'Neill | 6/3/2018 | https://www.cfpa.com/CourseDescription/CourseDescription/1802903O2801A/2801 |
| Audits/Inspections | Laboratory Controls: Anticipate the Systems Based FDA Inspection | CfPA Webinar | Danielle DeLucy | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription/1801902O2792A/2792 |
| Audits/Inspections | Effective Audits in Medical Devices | IVT Jr GXP Compliance Vol 23 Issue 4 | Alan Golden | 12/22/2020 | https://www.ivtnetwork.com/article/effective-audits-medical-devices |
| Audits/Inspections | Digitization Of Validation For Effective Off-Site Regulatory “Review” and “Inspection” | IVT Jr GXP Compliance Vol 23 Issue 4 | Siva Samy, Ajaz Hussain and Alton Johnson | 1/26/2021 | https://www.ivtnetwork.com/article/digitization-validation-effective-site-regulatory-%E2%80%9Creview%E2%80%9D-and-%E2%80%9Cinspection%E2%80%9D |
| Audits/Inspections | Audit Forum #1: Preparing For Remote GMP and GDP Audits | IVT Jr JVT V27I2 | Jeanne Moldenhauer | 4/27/2021 | https://www.ivtnetwork.com/article/audit-forum-1-preparing-remote-gmp-and-gdp-audits |
| Beyond Use Dating | BUDs for Sterile Preparations and Stability in Compounding Pharmacies | IVT Jr Val Tech | Rick Rhoades | 2/23/2021 | https://www.ivtnetwork.com/article/buds-sterile-preparations-and-stability-compounding-pharmacies-podcast-recording |
| Beyond Use Dating | USP Beyond-Use Date (BUD) Provisions in General Chapters <795> and <797> | USP Forum | Abby Dilley | 9/15/2020 | file:///C:/Users/Stability1/Downloads/USP_Stakeholder_Engagment_Open_Forum_Presentation.pdf |
| Biologics/Biotech Stability | Characterization Methods for the Physical Stability of Biopharmaceuticals | PDA Journal of Pharmaceutical Science and Technology | Danielle DeLucy | 3/1/2019 | https://www.ncbi.nlm.nih.gov/pubmed/14765559 |
| Biologics/Biotech Stability (new) | Principles, approaches, and challenges for predicting protein aggregation rates and shelf life | Jr of Pharm Sci | Weiss, Young, Roberts | 4//1/2009 | https://jpharmsci.org/article/S0022-3549(16)32925-2/fulltext |
| Biologics/Biotech Stability | Principles of Protein Stability and Their Application in Computational Design | Annual Review of Biochemistry | Adi Goldenzweig and Sarel J. Fleishman | 6/1/2018 | https://www.annualreviews.org/doi/abs/10.1146/annurev-biochem-062917-012102 |
| Biologics/Biotech Stability | Genome DNA leakage of Adeno–Associated virus under freeze–thaw stress | International Journal of Pharmaceutics | YuechuanXuaBowenJiangaPoulamiSamaibSven-MollerTankbMohammedShameemaDingjiangLiu | https://www.sciencedirect.com/science/article/abs/pii/S0378517322000175?via%3Dihub# | |
| Biologics/Biotech Stability | Employing Single-Use Technology to Control Frozen Bulk Drug Storage: The Cold Hard Facts | Entegris Whitepaper | Mike W Johnson, Bill Scott | 3/17/2022 | https://vertassets.blob.core.windows.net/download/9a3bbeac/9a3bbeac-bc68-476e-84ff-cdb9135a9b6b/whitepaper_employing_singleuse_technology_control_frozen_bulk_drug_storage_10394.pdf |
| Climate Zones | Storage Conditions for Stability Testing of Pharmaceuticals in Hot and Humid Regions | Volume 615 | Bott, Oliveira | 5/1/2017 | https://www.ncbi.nlm.nih.gov/pubmed/17523004 |
| Climate Zones | Climatic Zones for Stability Studies | Vol. 87:105-129 | Ankur Choudhary | 7/12/2008 | https://www.pharmaguideline.com/2010/12/different-climatic-zones-for-stability.html |
| Compliance (New 11/2021) | Takeaways from Recent FDA Warning Letters & 483s | IVT Jr GXP Compliance | Anu Seth | 3/7/2014 | https://www.ivtnetwork.com/article/stability-testing-compliance-key-takeaways-recent-fda-warning-letters-and-483s |
| Compliance | In 2021 again Numerous FDA 483s due to Deficiencies in the Stability Program | ECA Academy | Unidentified | 11/17/2021 | https://www.gmp-compliance.org/gmp-news/in-2021-again-numerous-fda-483s-due-to-deficiencies-in-the-stability-program |
| Compliance | Technical Writing for Compliance Part 1 | IVT Jr GXP Compliance Vol 23 Issue 4 | Paul L. Pluta, Richard Poska | 7/24/2019 | http://www.ivtnetwork.com/article/technical-writing-compliance-part-1-overview |
| Compliance | A Holistic Approach to Quality in the Pharmaceutical QC Laboratory | IVT Jr GXP Compliance Vol 23 Issue 3 | Karen Ginsbury | 5/23/2019 | http://www.ivtnetwork.com/article/holistic-approach-quality-pharmaceutical-qc-laboratory |
| Compliance | Application of GMP in the Cannabis Industry | IVT Jr GXP Compliance Vol 23 Issue 3 | Karina Lahnakoski | 3/28/2019 | http://www.ivtnetwork.com/article/application-gmp-cannabis-industry#32hioqz |
| Contractors | Regulatory Impact on the Management of Pharmaceutical Contract Manufacturers (CMO’s) | CfPA Webinar | Frank Carroll | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription/1802902O2797AF/2797 |
| Cosmetics | Stability Testing Guidance for Product Safety and Shelf Life Insight | Cosmetics & Toiletries | Ken Edwards | 1/3/2019 | https://humiditycontrol.com/stability-testing-cosmetics-shelf-life/ |
| Data Integrity | Introduction to Data Quality | IVT Jr GXP Compliance Vol 26 Issue 2 | Orlando Lopez | 4/27/2020 | https://www.ivtnetwork.com/article/introduction-data-quality |
| Data Integrity | What is Data Integrity and Why is it Important? | IVT Jr GXP Compliance Vol 22 Issue 5 | John E Lincoln | 2/16/2017 | http://www.ivtnetwork.com/article/what-data-integrity-and-why-it-important |
| Data Integrity | Audit Trails And Data Integrity In Pharmaceuticals And Life Sciences | IVT Jr GXP Compliance Vol 24 Issue 3 | Ivan Soto | 5/26/2020 | https://www.ivtnetwork.com/article/audit-trails-and-data-integrity-pharmaceuticals-and-life-sciences |
| Data Integrity | Contemporaneous Data Recording: How Does It Impact The Analytical Laboratory? | IVT Jr GXP Compliance Vol 25 Iss 2 | Greg Vanderstel and Kim Huynh-Ba | 3/24/2021 | https://www.ivtnetwork.com/article/contemporaneous-data-recording-how-does-it-impact-analytical-laboratory |
| Data Integrity | Data Integrity Background and Frequently Asked Questions | IVT Jr GXP Compliance Vol 22 Issue 5 | Karen Ginsbury | 5/30/2017 | http://www.ivtnetwork.com/article/data-integrity-background-and-frequently-asked-questions |
| Data Integrity | Stability Data Integrity: Building a Governance Program | KENX Library | Emily S. D. Trubee | 6/17/2019 | Request from info@kenx.org |
| Data Integrity | Identification and Management of Critical Data | IVT Podcast | Chris Wubbolt | 1/12/2021 | https://www.ivtnetwork.com/article/identification-and-management-critical-data |
| Data Integrity | MHRA Data Integrity Guidance: Implementation Approach | IVT Jr GXP Compliance Vol 22 Issue 5 | Ivan Soto | 5/30/2017 | https://www.ivtnetwork.com/article/mhra-data-integrity-guidance-implementation-approach |
| Data Integrity | Closing the Gap on Data Integrity | IVT Jr GXP Compliance Vol 22 Issue 5 | Scott A. Davis | 9/24/2018 | http://www.ivtnetwork.com/article/closing-gap-data-integrity |
| Data Integrity | Data Integrity Mock Inspection - Mitigating Risk | IVT Labweek Dec 2020 | Alyce Deegan | 1/13/2020 | https://www.ivtnetwork.com/article/data-integrity-mock-inspection-mitigating-risk |
| Data Integrity | 21 CFR Part 11 Compliance: Facts & Myths | IVT webinar | Ivan Soto | 4/6/2018 | http://www.ivtnetwork.com/video/21-cfr-part-11-compliance-facts-myths |
| Data Integrity (New 10/2021) | The Top Five Data Integrity Issues in GXP Environments | IVT Podcast | Chris Wubbolt | 10/12/2021 | https://www.ivtnetwork.com/article/top-five-data-integrity-issues-gxp-environments |
| Data Integrity | CGMP E-Records Risk Assessments | IVT Jr GXP Compliance Vol 22 Issue 5 | Orlando Lopez | 9/24/2018 | http://www.ivtnetwork.com/article/cgmp-e-records-risk-assessments |
| Data Integrity | Spreadsheets and Data Integrity | IVT Jr GXP Compliance Vol 22 Issue 5 | Ivan Soto | 9/24/2018 | http://www.ivtnetwork.com/article/spreadsheets-and-data-integrity |
| Data Integrity | The 5P Model for Data Integrity | IVT Jr GXP Compliance Vol 22 Issue 5 | Chinmoy Roy | 9/24/2018 | http://www.ivtnetwork.com/article/5p-model-data-integrity |
| Data Integrity | Data Integrity for Your Laboratory Computerized Systems | IVT Jr GXP Compliance Vol 22 Issue 5 | Lynn Archambault | 6/7/2017 | http://www.ivtnetwork.com/article/data-integrity-your-laboratory-computerized-systems |
| Data Integrity | Data Integrity Strategies for Migrating Data from Legacy Systems | IVT Jr GXP Compliance Vol 22 Issue 5 | Ivan Soto | 9/26,2017 | http://www.ivtnetwork.com/article/data-integrity-strategies-migrating-data-legacy-systems |
| Data Integrity | Data Integrity Strategy Document Essentials | Data Integrity | Orlando Lopez | 1/20/2022 | https://www.ivtnetwork.com/article/data-integrity-strategy-document-essentials |
| Devices | Test Method Selection & Spec Setting in Stability Testing for Comb Med Dev Products | IVT Jr GXP Compliance | Jian Liu, Thomas Chiesal Marika Kamberi | 11/21/2018 | https://www.ivtnetwork.com/article/test-method-selection-and-specification-setting-stability-testing-combination-medical-devi-0 |
| Devices/Combination Products | Shelf Life Determination for Combination Medical Device Products | Pharmaceutical Outsourcing | Jian Liu, Thomas Chiesl, Fuh-Wei Tang, Marika Kamberi | 8/18/2018 | https://www.pharmoutsourcing.com/Featured-Articles/352944-Shelf-Life-Determination-for-Combination-Medical-Device-Products/ |
| Devices | Letter to FDA Technical Considerations Demonstrating Reliability Of Emergency-Use Injectors Submitted Under BLA/NDA/ANDA | IVT Jr GXP Compliance Vol 26, Issue 3 | Paul L. Pluta ,Richard Poska | 6/25/2020 | https://www.ivtnetwork.com/article/letter-fda-technical-considerations-demonstrating-reliability-emergency-use-injectors-submit |
| Devices | Technical Considerations For Demonstrating Reliability Of Emergency-Use Injectors: A Review Of Draft FDA Guidance For Industry | IVT Jr GXP Compliance Vol 26, Issue 3 | Richard Poska | 5/26/2020 | https://www.ivtnetwork.com/article/technical-considerations-demonstrating-reliability-emergency-use-injectors-review-draft-fda- |
| Disaster Planning | Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program Impacts | Data Integrity | K Huynh-ba, Laure Larkin | 8/26/2020 | https://www.ivtnetwork.com/article/placing-patient-safety-first-developing-disaster-plan-reduce-risks-covid-19-stability-progra |
| Excursions | Excursions and In-Use: Stability Beyond ICH | KENX Library | Richard Poska | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/18_MKrischKENX.FreeThink.MJK_.Talk2_.Final-1-1.pdf |
| Excursions | Environmental Excursions and Drug Product Stability | IVT Jr GXP Compliance Vol 22 Issue 5 | Karen R Zimm | 9/19/2019 | http://www.ivtnetwork.com/article/environmental-excursions-and-drug-product-stability |
| Excursions | Chamber Excursions; Dealing with Your Chamber's Vacation | StabilityHub | John O'Neill | 3/30/2021 | https://1drv.ms/p/s!AnCQXwcJJPzZjgl6Drp0BU2V6zdO?e=B7Jc0D |
| Excursions | How to Investigate Temperature and Humidity Excursions of Stability Chambers | American Pharmaceutical Review | Kim Huynh-Ba* - Managing Director - Pharmalytik, LLC and Chris Latoz - Stability Manager - Hollister Incorporated | 6/23/2021 | https://www.americanpharmaceuticalreview.com/Featured-Articles/577076-How-to-Investigate-Temperature-and-Humidity-Excursions-of-Stability-Chambers/ |
| Extractables & Leachables(3/22) | Mitigating Hidden Risks: Extractables And Leachables | Cambrex/Cell &Gene | Chistopher Wittum | 3/29/2022 | https://www.cellandgene.com/doc/mitigating-hidden-risks-extractables-and-leachables-0001?vm_tId=2396035&vm_nId=70810&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=Mitigating%20Hidden%20Risks%3A%20Extractables%20And%20Leachables&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_03-29-2022&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=Mitigating%20Hidden%20Risks%3A%20Extractables%20And%20Leachables&mkt_tok=MDc1LU5WQy0wODYAAAGDdjPjRH-FITDZUFrXABVxGNB2zcIJlQPnGdUrpXX1NLF0evA_91oE83Xv1x2YXtGHuQhNafMQL1nGpR86cXAAZQ0kHlTdY3XW1MTvmbn1pUwO |
| Extractables & Leachables(5/22) | Advancing Extractables and Leachables Testing | European Pharmaceutical Review | Hannah Balfour | https://www.europeanpharmaceuticalreview.com/article/170814/advancing-extractables-and-leachables-testing/?utm_source=Email+marketing&utm_medium=email&utm_campaign=EPR+-+Industry+Insight+-+Mettler+Toledo+-+27.05.22&utm_term=Advancing+extractables+and+leachables+testing&utm_content=https%3a%2f%2femails.europeanpharmaceuticalreview.com%2frussellpublishinglz%2f&gator_td=X%2bbqjE2oYcDIORG%2fEkAdh7BK1C%2fsPvSTpNUYsmh7XMlkvLl74ZdH7EpaDUUXPoPw154gjQzAuNfGzbaGV3c5R6fZuQcCp4Z6YVq6QJvXfHWqrbSsKrgeZlRE7nRDOteVm8kT6Nuhxg9x%2bn3tYZoB%2fpZ1v29gLC4%2b7Pe1MAyKgiyf6RJVTpKqTkqiDyek8WCGx2lJrNmfwN0rTe%2bI6PoU8DXq7LslCpoAlIzu8BoxmnQ%3d | |
| Facilities | Risk Management and Trending in Pharmaceutical Grade Water, HVAC & Utility Systems | Novatek | Susan Cleary | 5/2/2022 | https://ntint.com/utility-monitoring-whitepaper/?utm_medium=email&_hsmi=211577019&_hsenc=p2ANqtz-8PRKYaTXU1dV4V_u8bY5Mh1WQX5iYnZcppjUnAczs9zUrkK4NkiWwMKRCCAYh1f7KV7roiwxnPENSkhIqHTb_I-bWrgA&utm_content=211577019&utm_source=hs_email |
| Field Alerts | REGULATORY 101 - Field Alert Reports | IVT Jr GXP | Karen R Zimm | 3/20/2020 | https://www.ivtnetwork.com/article/regulatory-101-field-alert-reports |
| Forced Degradation | Pharmaceutical Stress Testing | Pharmaceutical Stress Testing (Informa Healthcare) | Steven W. Baertschi, Karen M. Alsante and Robert A. Reed, Editors | 12/31/2011 | https://www.taylorfrancis.com/books/e/9780429136085 |
| Forced Degradation | Conducting Forced Degradation Studies | KENX Library | Geoff Carr | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/28_GCarrForced-Degradation-Studies-Handouts-9th-May-20191-1.pdf |
| Forced Degradation | Advanced Stability Testing and Program Management: Forced Degradation and Impurity Monitoring | KENX Library | Kim Huynh-Ba | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/2018_10_23_Stability-Day-2_Advanced-compressed-1.pdf |
| Forced Degradation | Zeneth: A knowledge-based system for the prediction of forced degradation of organic compounds | Sci of Stability Conference | Ash Ali | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Forced Degradation | The Use of Safety Based Arguments to Support Degradation Product Limits | Sci of Stability Conference | David P. Elder | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Forced Degradation | Enrichment of Relevant Oxidative Degradation Products in Pharmaceuticals with Targeted Chemoselective Oxidation | Sci of Stability Conference | Kausik Nanda | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Forced Degradation | Analytical method development for the determination of drug degradation: case studies | Sci of Stability Conference | Claudio Brunelli | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Forced Degradation | Drug Photostability: The Science and Application of Photo-Produced Reactive Oxygen Species | Sci of Stability Conference | Steve Baertschi | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Forced Degradation new 1/22 | New developments in the pharmaceutical stress testing industry | European Pharmaceutical Review | Ana Cláudia Santos (Merck Brazil), Chris Foti (Gilead Sciences), Flavia Firmino (Pfizer), John Campbell (GlaxoSmithKline), Steven Baertschi (Baertschi Consulting) | 12/22/2021 | https://www.europeanpharmaceuticalreview.com/article/166441/new-developments-in-the-pharmaceutical-stress-testing-industry/ |
| Forced Degradation new 1/22 | Available Guidance & Best Practices for Conducting Forced Degradation Studies | Pharmaceutical Techology | Reynolds et al | 2/20/2002 | https://www.researchgate.net/profile/Dan-Reynolds-3/publication/279607256_Available_Guidance_and_Best_Practices_for_Conducting_Forced_Degradation_Studies/links/5afd6a2ca6fdcc3a5a44c50f/Available-Guidance-and-Best-Practices-for-Conducting-Forced-Degradation-Studies.pdf |
| General Stability Reference | Handbook of Stability Testing | Handbook of Stability Testing in Pharm Dev: Regulations, Methodologies, & Best Practices | Kim Huynh-Ba, Editor | 1/1/2009 | https://www.springer.com/gp/book/9780387856261 |
| General Stability Reference | Pharmaceutical Stability Testing | Pharmaceutical Stability Testing to Support Global Markets | Kim Huynh-Ba, Editor | 1/1/2010 | https://www.springer.com/gp/book/9781441908889 |
| General Stability Reference | Methods for Stability Testing | Humana Press | Sanjay Bajaj and Saranjit Singh, Editors | 12/31/2018 | https://www.springer.com/gp/book/9781493976850 |
| General Stability Reference | Evaluation of Stability Data | Handbook of Stability Testing in Pharm Dev: Regulations, Methodologies, & Best Practices | Nanda Subbarao, Kim Huynh-Ba | 1/1/2009 | https://link.springer.com/chapter/10.1007%2F978-0-387-85627-8_13 |
| General Stability Reference | Stability Studies and Testing of Pharmaceuticals - An Overview | chromatographyonline.com | Michael W. Dong, Kim Huynh-Ba | 6/1/2020 | https://www.chromatographyonline.com/view/stability-studies-and-testing-pharmaceuticals-overview |
| Herbal Stability Studies | MPA 204T: Herbal and Cosmetic Analysis | Research Gate | Sumanta Mondal | 7/10/2021 | https://www.researchgate.net/publication/353067882_MPA_204T_HERBAL_AND_COSMETIC_ANALYSIS |
| In Use | Excursions and In-Use: Stability Beyond ICH | KENX Library | Maria Krisch | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/18_MKrischKENX.FreeThink.MJK_.Talk2_.Final-1-1.pdf |
| In Use | Prevalence of tablet splitting in a Brazilian tertiary care hospital | Pharmacy Practice 18(2):1910 | Vivianne Melo, Gessyka Pereira, Amanda Soares, Izabel Silva, Stephania Taveira, Marcílio Cunha-Filho, Ricardo Marreto | 6/1/2020 | https://www.researchgate.net/publication/341833291_Prevalence_of_tablet_splitting_in_a_Brazilian_tertiary_care_hospital |
| In Use | Shelf Life Assessment of Drug Product after opening Container for the first time | IJSDR1808013V3I8 | Bawazir et al | 8/1/2018 | https://www.ijsdr.org/papers/IJSDR1808013.pdf |
| In Use (new 1/22) | Discussion on the Technical Requirements and Methods for In-use (CHINA) | Chinese Journal of Clinical Pharmacology/FreeThink Tech Library | Zhao Na* | 1/1/2022 | https://freethinktech.com/wp-content/uploads/2022/01/Chinese-Journal-Article-English.pdf |
| Investigations | Stability Testing of Drug Products | IVT Jr GXP Compliance Vol. 24, Issue 4 | National Drug Administration, Drug Evaluation Center, Beijing, China 100022 | 7/28/2020 | https://www.ivtnetwork.com/article/investigation-deviations-why-are-they-so-painful |
| Investigations | Root Cause Analysis- A Systemic Approach | IVT Jr GXP Compliance Vol 22 Issue 5 | Ronald Snee | 1/23/2018 | http://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systematic-approach |
| Investigations New 1/22 | Inadequate OOS Investigations lead to FDA Warning Letter | ECA Academy | unidentified | 1/26/2022 | https://www.gmp-compliance.org/gmp-news/inadequate-oos-investigations-lead-to-fda-warning-letter |
| Investigations New 1/22 | Managing Workplace Error Part 1: Unpicking Patterns Of Human Error | IVT Blog | Tim Sandle | 1/12/2022 | https://www.ivtnetwork.com/article/managing-workplace-error-part-1-unpicking-patterns-human-error |
| Investigations New 1/22 | Managing Workplace Error #2: Getting to the Heart of the Matter Through Human Error Checklists | IVT Blog | Tim Sandle | 1/13/2022 | https://www.ivtnetwork.com/article/managing-workplace-error-2-getting-heart-matter-through-human-error-checklists |
| Investigations New 1/22 | Managing Workplace Error #3: Dissecting Reasons and Causes of Laboratory Error | IVT Blog | Tim Sandle | 1/13/2022 | https://www.ivtnetwork.com/article/managing-workplace-error-3-dissecting-reasons-and-causes-laboratory-error |
| Investigations | Deviation Management - Why Have We Not Solved the Problem? | IVT Jr GXP Compliance Vol 22 Issue 5 | David Husman | 1/23/2018 | http://www.ivtnetwork.com/article/deviation-management-why-have-we-not-solved-problem |
| Investigations (New 10/21) | Critical Thinking #1: Why Pharmaceuticals & Healthcare Needs More Critical Thinkers | IVT Jr GXP Compliance Vol 22 Issue 5 | Tim Sandle | 9/24/2021 | https://www.ivtnetwork.com/article/critical-thinking-1-why-pharmaceuticals-and-healthcare-needs-more-critical-thinkers-ivt-blog |
| Laboratory | Facilitating The Lean Laboratory: A Case Study Using The 5S Approach | IVT Jr GXP Compliance Vol. 24, Issue 4 | Tim Sandle | 7/28/2020 | https://www.ivtnetwork.com/article/facilitating-lean-laboratory-case-study-using-5s-approach |
| Laboratory | Laboratory sample stability. Is it possible to define a consensus stability function? | De Gruyter | Rubén Gómez Rioja ORCID logo, Débora Martínez Espartosa, Marta Segovia, Mercedes Ibarz ORCID logo, María Antonia Llopis, Josep Miquel Bauça, Itziar Marzana, Nuria Barba, Monserrat Ventura, Isabel García del Pino, Juan José Puente, Andrea Caballero, Carolina Gómez, Ana García Álvarez, María Jesús Alsina and Virtudes Álvarez | 5/5/2018 | https://www.degruyter.com/document/doi/10.1515/cclm-2017-1189/html |
| Laboratory | When Sample Temperature Matters: How to Keep Your Cool in the Lab | LabRoots | LabCon | 3/15/2021 | https://www.labroots.com/trending/cell-and-molecular-biology/19985/sample-temperature-matters-cool-lab |
| Laboratory | Changes To Analytical Equipment/Instrumentation That Are Deemed Equivalent | IVT Quality & Validation | Emma Ramnarine, Richard Rolke | 7/15/2021 | https://www.ivtnetwork.com/article/changes-analytical-equipmentinstrumentation-are-deemed-equivalent-0 |
| LIMS | Stability LIMS-Selection, Implementation and Validation | KENX Library | Chris Latoz | 6/27/2018 | https://s3-us-east-2.amazonaws.com/cavettek-sites/stabilityhub/wp-content/uploads/20191108202241/KENX-Stability-Conference-June-2018-Final.pdf |
| Mapping | Planning a Successful Warehouse Mapping Study | IVT Network.com | Alex Debreceni | 7/23/2019 | http://ivtnetwork.com/article/planning-successful-warehouse-mapping-study |
| Methods | Analytical Method Validation for Biopharmaceuticals, Part 1: Intro & System Suitability | IVT Jr Val Tech Vol 22 Issue 6 | Drew Kelner, Ira Krull, Robert Duff, Tamer Eris | 12/12/2016 | https://www.ivtnetwork.com/article/analytical-method-validation-biopharmaceuticals-part-1-introduction-and-system-suitability |
| Methods | Analytical Method Validation for Biopharmaceuticals, Part 2: Intro & System Suitability | IVT Jr Val Tech Vol 23 Issue 1 | Drew Kelner, Ira Krull, Robert Duff, Tamer Eris | 2/12/2017 | https://www.ivtnetwork.com/article/analytical-method-validation-biopharmaceuticals-part-2 |
| Methods | Analytical Methods Validation for FDA Compliance | CFPA Course | J. Mark Green, David E Wiggins | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription?Offering=0&CourseID=1887 |
| Methods | HPLC (High Performance Liquid Chromatography): Method Development | CfPA Webinar | Rachel Monsef | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription/17119022680A/2680 |
| Methods | HPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins | CfPA Webinar | Rachel Monsef | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription?Offering=17119032681A&CourseID=2681 |
| Methods | Biopharmaceutical Analytics: Regulations and Validations | CfPA Webinar | Rachel Monsef | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription/1907901OP2863A/2863 |
| Methods | Current Analytical Testing Methods for Cannabis and Hemp Based Products | CFPA Course | Raghvendra Sahai | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription/1907904OL2865A/2865 |
| Methods | Test Method Selection & Spec Setting in Stability Testing for Comb Med Dev Products | IVT Jr GXP Compliance Vol 22 Issue 6 | Jian Liu, Thomas Chiesl Marika Kamberi | 11/1/2018 | http://www.ivtnetwork.com/article/test-method-selection-and-specification-setting-stability-testing-combination-medical-devi-0 |
| Methods | Solid-State NMR to Understand Pharmaceutical Stability | Sci of Stability Conference | Steven Brown | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Methods | Isothermal Microcalorimetry for Pharmaceutical Stability Assessment | Sci of Stability Conference | Malin Suurkuusk | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Methods | The Method Detectives: Building a New Business Model with Analytical Procedure (Method) Lifecycle Management | Waters | Alexander Schmidt, Mijo Stanic | 4/7/2022 | https://vertassets.blob.core.windows.net/download/a5693487/a5693487-df43-4569-8f23-1ad234e40324/720006481en.pdf |
| Methods New 5/22 | Implement USP 922 Water Activity into Stability and Packaging Studies | LightHouse Webinar | Michael Lally | 4/1/2022 | https://lighthouseinstruments.com/lp/webinar-implement-usp922-water-activity/osd |
| Methods New 7/2022 | Introduction to USP-922 General Chapter for Water Activity Measurement | Lighthouse | Michael Lally | 7/1/2022 | https://lighthouseinstruments.com/wp-content/uploads/2022/06/LH-Article-Introduction-to-USP-922-V4.pdf |
| Methods New 7/2022 | Headspace Moisture Analysis for Determination of Residual Moisture Content in Lyophilized Pharmaceutical Products | Lighthouse | Derek Duncan | 7/1/2022 | https://lighthouseinstruments.com/wp-content/uploads/2022/03/LHI-Article-Lyophilization_moisture-analysis-in-Lyo-products_DD_2022.pdf |
| Metrics | Implimenting Quality Metrics for Validation | IVT Podcast | Ivan Soto | 4/14/2020 | https://www.ivtnetwork.com/article/implementing-quality-metrics-validation-0 |
| Microbial Testing | A practical approach to microbial testing to support non-sterile product stability | European Pharmaceutical Review | unidentified | 12/3/2008 | https://www.europeanpharmaceuticalreview.com/article/1196/a-practical-approach-to-microbial-testing-to-support-non-sterile-product-stability/ |
| Microbial Testing | Microbial Identification strategy for pharmaceutical microbiology | IVT Jr GXP Compliance | Tim Sandle | 7/25/2017 | https://www.ivtnetwork.com/article/microbial-identification-strategy-pharmaceutical-microbiology |
| Microbial Testing | Inhibition of microbial growth in solid dosages at ICH stability storage conditions | European Pharmaceutical Review | Linda Skowronsky | 8/31/2011 | https://www.europeanpharmaceuticalreview.com/article/8876/inhibition-of-microbial-growth-in-solid-dosages-at-ich-stability-storage-conditions/ |
| Microbial Testing | Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program | CfPA Webinar | Charity Ogunsanya | 9/24/2019 | https://www.cfpa.com/CourseDescription/CourseDescription/1909903OL2567L/2567 |
| Microbial Testing | Variability and the LAL Assay for Bacterial Endotoxin Detection | IVT Jr GXP Compliance Vol 22 Issue 6 | Tim Sandle | 9/19/2019 | http://www.ivtnetwork.com/article/variability-and-lal-assay-bacterial-endotoxin-detection |
| Microbial Testing | Regulatory 101: Preservative Efficacy Test | IVT Jr GXP Compliance Vol. 25, Issue 1 | Karen R. Zimm | 1/26/2021 | https://www.ivtnetwork.com/article/regulatory-101-preservative-efficacy-test |
| Microbial Testing 1/21/2022 | A practical approach to microbial testing to support non-sterile product stability | European Pharmaceutical Review | Not disclosed | 12/3/2008 | https://www.europeanpharmaceuticalreview.com/article/1196/a-practical-approach-to-microbial-testing-to-support-non-sterile-product-stability/ |
| Out of Specs, Trend, Expectation | Out-of-Specification & Out-ofTrend Investigations for Analytical Testing | KENX Library | Emily S. D. Trubee | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/15_ETrubee_OOSOOT-Investigations-1-1.pdf |
| Out of Specs, Trend, Expectation | Out-of-Specification Laboratory Investigations: New Look at an Old Issue | IVT Jr GXP Compliance Vol 22 Issue 6 | Tim Sandle | 11/20/2018 | http://www.ivtnetwork.com/article/out-specification-laboratory-investigations-new-look-old-issue |
| Out of Specs, Trend, Expectation | Performing an Effective Sterility Failure Investigation | CfPA Webinar | Charity Ogunsanya | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription?Offering=1709905O2766A&CourseID=2766 |
| Out of Specs, Trend, Expectation | Out-of-Specification (OOS) Result Investigation | CfPA Webinar | Charity Ogunsanya | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription/1906902OL2581A/2581 |
| Out of Specs, Trend, Expectation | Inadequate OOS Investigations lead to FDA Warning Letter | ECA Academy | unidentified | 1/26/2022 | https://www.gmp-compliance.org/gmp-news/inadequate-oos-investigations-lead-to-fda-warning-letter |
| Packaging | Using finite element analysis to determine blister permeability from tooling design | Sci of Stability Conference | Daniel Stagnaro | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Packaging | Protective Blister Packaging Materials: Aclar® | Sci of Stability Conference | Thomas Dries | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Packaging | Container Closure Integrity Overview and USP 1207 Guidance | PTI Inspection Systems | unidentified | 2/1/2021 | https://higherlogicdownload.s3.amazonaws.com/AAPS/bfc3a388-f31c-452f-88fd-941c2a445a10/UploadedImages/Discussion_Groups_/2021AAPSCaliforniaChapter_Zecchin.pdf |
| Packaging new 3/2022 | Ensuring Container Closure Integrity During Deep Cold Storage and Transport | Pharma Mfging/Lighthouse | unidentified | 3/22/2022 | https://info.pharmamanufacturing.com/ebook-2022-lighthouse-pkg?utm_campaign=PH_2022_PCAs&utm_medium=email&_hsmi=207507360&_hsenc=p2ANqtz-8jEs6afnyHfow9GOj_HbO0g-K_UHKnt2owyzcHB5xgwmE6VwPnO_gzh1_lgVb3c5eT5neBwYUaGY8-5Eifo1GL7gJtvw&utm_content=207507360&utm_source=hs_email |
| Packaging new 2/2022 | Anti-counterfeit and security solutions for secondary packaging | Pharma Mfg & Colbert Packaging | unidentified | 2/8/2022 | https://info.pharmamanufacturing.com/white-paper-2021-colbert-packaging-anti-counterfeit-security-solutions-secondary-packaging_pkg?utm_campaign=PH_2022_PCAs&utm_medium=email&_hsmi=203183410&_hsenc=p2ANqtz-9EL8wr6S3Y6N6rgNBCBdjvYAIPRz9xFaBM8dtl82MZBcf5sZot_3PF25wCyvm-QqlK1n-gsjfQ8YcUBC10b8dDxyg2sg&utm_content=203183410&utm_source=hs_email |
| Packaging new 7/2022 | Quality Stability Testing: Oxygen Monitoring during Shelf Life | LightHouse | unidentified | 7/1/2022 | https://lighthouseinstruments.com/wp-content/uploads/2022/03/CS-Oxygen-Monitoring-Shelf-Life-2022.pdf |
| Pandemic | Stability and infectivity of coronaviruses in inanimate environments | World J Clin Cases. 2020 Apr 26; 8(8): 1391–1399 | Shi-Yan Ren, Wen-Biao Wang, Ya-Guang Hao, Hao-Ran Zhang, Zhi-Chao Wang, Ye-Lin Chen, and Rong-Ding Gao | 4/26/2020 | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7190947/ |
| Pharmacopoeia | "Pharmacopoeias: Basics for Compendial Compliance | CfPA Webinar | J. Mark Wiggins | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription/1707910O2773AF/2773 |
| Pharmacopoeia | Pharmacopoeias: A Global Perspective for Compendial Compliance | CfPA Webinar | J. Mark Wiggins | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription/180727OP2728A/2728 |
| Photostability | In-Use Photostability Practice and Regulatory Evaluation for Pharmaceutical Products in an Age of Light-Emitting Diode Light Sources. | J Pharm Sci. | Leonardo R. Allain Brittany C. Pierce, W. Peter Wuelfing, Allen C. Templeton, Roy Helmy | 10/10/2018 | https://jpharmsci.org/article/S0022-3549(18)30600-2/pdf |
| Photostability | Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug Products | Journal of Pharmaceutical Sciences May 2016 Volume 105, Issue 5, Pages 1586–1594 | Leonardo Allain, Steven W. Baertschi, David Clapham, Chris Foti, Wendy M. Lantaff, Robert A. Reed, Allen C. Templeton, Hanne Hjorth Tønnesen | 5/1/2016 | https://jpharmsci.org/article/S0022-3549(16)00403-2/abstract |
| Photostability | Implications of Photostability on the Mfging, Pkging, Storage & Testing of Formulated Pharmaceutical Products | Pharmaceutical Technology MARCH 2005 p. 68 | Allen C. Templeton, Hui Xu, Jiri Placek, and Robert A. Reed | 3/1/2005 | https://www.researchgate.net/publication/289140712_Implications_of_photos |
| Physical Testing | What the Eye Can See: Vision Requirements for Personnel Who Inspect Injectable Pharmaceuticals | IVT Blog | Tim Sandle | 1/27/2022 | https://www.ivtnetwork.com/article/what-eye-can-see-vision-requirements-personnel-who-inspect-injectable-pharmaceuticals |
| Post Approval | Post Approval Changes for Test Methods & Specifications in Stability Testing for Combination Products Jian Liu | KENX Library | Jian Liu | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/7_JLiu_1_Post-approval-changes-for-test-methods-Specifications-for-combination-products_V2_Jian-Liu_final_0531191-1-1.pdf |
| Process Improvement | Implement an Enjoyable Continuous Improvement Process for Your Stability Function | KENX Library | John O'Neill | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/17_JOneil_-2_Implement-Enjoyable-CI-1-1.pdf |
| Protocols and Study Designs | Designing Phase-Appropriate Stability Study Programs for Drug Substances and Drug Products | Pharmaceutical Outsourcing | Wei Pan | 8/9/2018 | https://www.pharmoutsourcing.com/Featured-Articles/352619-Designing-Phase-Appropriate-Stability-Study-Programs-for-Drug-Substances-and-Drug-Products/ |
| Protocols and Study Designs | Reduced Study Designs for Registration Stability Programs | KENX Library | Geoff Carr | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/10_GCarr_Reduced-Study-Designs-Handouts-8th-May-20191-1-1.pdf |
| Protocols and Study Designs | OTC Stability Program for FDA Compliance | CFPA Course | David E. Wiggins | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription?Offering=0&CourseID=2650 |
| Protocols and Study Designs | Stability Testing for Protein Drug Products & Substances | CFPA Course | Pardeep K. Gupta | Unknown | https://www.cfpa.com/CourseDescription/CourseDescription?Offering=0&CourseID=2594 |
| Protocols and Study Designs | Towards global stability protocols: a decade of lost opportunities | European Pharmaceutical Review | editorial staff | 4/18/2013 | https://www.europeanpharmaceuticalreview.com/article/18467/towards-global-stability-protocolsa-decade-of-lost-opportunities/ |
| Regulations and Guidances | Stability Regulations and Guidances | KENX Library | John O'Neill | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/2_JOneil_Stability-Regulations-and-Guidance-1-1.pdf |
| Regulations and Guidances | Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies | AAPS Jr Sep 2021 | ME McMahon et al | 9/16/2021 | https://pubmed.ncbi.nlm.nih.gov/34529169/ |
| Regulations and Guidances | The Eleventh Conference of the Chinese Pharmacopoeia Commission Executive Committee Held in Beijing — Review and Approve the Draft of ChP 2020 Edition | Not Disclosed | National Medical Products Administration | 4/13/2020 | http://english.nmpa.gov.cn/2020-04/13/c_500127.htm |
| Regulatory Submissions | CMC Writing and Submission Strategies: A Global Regulatory Approach | CFPA Course | Shrinivas (Cheenu) Murti | 10/10/2019 | https://www.cfpa.com/CourseDescription/CourseDescription/191010NJ1989/1989 |
| Regulatory Submissions | CMC Simulation: A Hands-on Approach to Global Marketing Applications | CFPA Course | Shrinivas (Cheenu) Murti | 10/9/2019 | https://www.cfpa.com/CourseDescription/CourseDescription/191009NJ2634/2634 |
| Regulatory Submissions | FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products | Cell & Gene | Mark Durivage | 7/14/2021 | https://www.cellandgene.com/doc/fda-releases-guidance-on-cmc-changes-to-an-approved-application-certain-biological-products-0001?vm_tId=2325790&vm_nId=66743&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=FDA%20Releases%20Guidance%20On%20Chemistry,%20Manufacturing,%20And%20Controls%20(CMC)%20Changes%20To%20An%20Approved%20Application%3A%20Certain%20Biological%20Products&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_08-12-2021&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=FDA%20Releases%20Guidance%20On%20Chemistry,%20Manufacturing,%20And%20Controls%20(CMC)%20Changes%20To%20An%20Approved%20Application%3A%20Certain%20Biological%20Products&mkt_tok=MDc1LU5WQy0wODYAAAF-2VIlqgi6RG9BJ817h7PRqJ7fCBTpQTJJs8g0uVjg6AyeK38kRsKKeN2b2KcRMVyXHqQTF1kSUmT32KQKVkDeJ6UN9CQdx6f3PMeQR96hWPQ |
| Risk Assessment | Risk Assessment and Lifecycle Management in Stability Testing | IVT Jr GXP Compliance Vol 22 Issue 6 | Naotaka Hata | 9/26/2017 | http://www.ivtnetwork.com/article/risk-assessment-and-lifecycle-management-stability-testing |
| Risk Assessment | Error Risk Reduction: Concept and Case Study | IVT Jr GXP | Tim Sandle | 12/16/2020 | https://www.ivtnetwork.com/article/error-risk-reduction-concept-and-case-study |
| Risk Assessment (New 1/2022) | Reducing Human Error In Gmp Pharma/Biopharma Operations | CAI Cell&Gene | Harry Benson | 4/15/2021 | https://www.cellandgene.com/doc/reducing-human-error-in-gmp-pharma-biopharma-operations-0001?vm_tId=2371206&vm_nId=69557&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=Reducing%20Human%20Error%20In%20GMP%20Pharma%2FBiopharma%20Operations&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_01-15-2022-wne&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=Reducing%20Human%20Error%20In%20GMP%20Pharma%2FBiopharma%20Operations&mkt_tok=MDc1LU5WQy0wODYAAAGB_Mw4xTztF_jIvQI9NTk6HbBjCB9Oze1K1ATYRvZW8Y_RIbBU8OzrQSox951-dqZn9lJT3VgZRefb77N2HQED5ULTUfElM5wo1WijAY2HZ8tc |
| Risk Assessment | Understanding the Concept of Formality In Quality Risk Management | IVT Jr GXP Compliance Vol 26 Issue 3 | Kevin O’Donnell, Deidre Tobin, Stephanie Butler, Ghada Haddad, and Donal Kelleher | 6/25/2020 | https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management |
| Risk Assessment | The Benefits Of Utilizing A Spectrum Of Importance In Industry | IVT Jr GXP Compliance Vol 26, Issue 3 | Daniel O'Regan and Cliff Campbell | 6/25/2020 | https://www.ivtnetwork.com/article/benefits-utilizing-spectrum-importance-industry |
| Risk Assessment | ICH Q( (R1) Quality Risk Management Revision | IVT Jr GXP | Paul L Pluta | 11/30/2020 | https://www.ivtnetwork.com/article/ich-q9-r1-quality-risk-management-revision |
| Risk Assessment | Risk Assessing The Risks: Deliberations On Risk Prioritization | IVT Jr GXP | Tim Sandle | 8/9/2021 | https://www.ivtnetwork.com/article/risk-assessing-risks-deliberations-risk-prioritization |
| Shelf Life | Shelf-Life Extensions For Pharmaceutical Products | IVT Jr GXP Compliance Vol 25, Issue 1 | Kevin Lombardi, Nasir Egal | 1/26/2021 | https://www.ivtnetwork.com/article/shelf-life-extensions-pharmaceutical-products-0 |
| Shelf Life | Do the Math for Shelf Life | Pharmaceutical Formulation & Quality V13#2 | Michelle Duncan Irene Zaretsky | 4/1/2011 | https://onedrive.live.com/?cid=D9FC2409075F9070&id=d9fc2409075f9070%2115036&parId=d9fc2409075f9070%21448&o=OneUp |
| Shelf Life | New Model Could be Used to Predict Shelf Life of Drugs | European Pharmaceutical Review | Victoria Rees | 7/23/2019 | https://www.europeanpharmaceuticalreview.com/news/94940/new-model-could-be-used-to-predict-shelf-life-of-drugs/ |
| Shelf Life (new 1/2022) | Long-term stability predictions of therapeutic monoclonal antibodies in solution using Arrhenius-based kinetics | Scientific Reports volume 11, Article number: 20534 (2021) | Drago Kuzman, Marko Bunc, Miha Ravnik, Fritz Reiter, Lan Žagar & Matjaž Bončina | 10/15/2021 | https://www.nature.com/articles/s41598-021-99875-9 |
| Shipping | Good Distribution Practice For Clinical Trial Materials | IVT Jr GXP Compliance Vol. 24, Issue 3 | Andrea Zobel | 5/29/2020 | https://www.ivtnetwork.com/article/good-distribution-practice-clinical-trial-materials |
| Shipping | Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products. | AAPS PharmSciTech. 2011 Dec;12(4):1264-75. doi: 10.1208/s12249-011-9684-0. Epub 2011 Sep 27 | C. Ammann | 9/27/2011 | https://www.ncbi.nlm.nih.gov/pubmed/21948319 |
| Shipping | Shocking Data on Parcel Shipments of Protein Solutions. | J Pharm Sci. 2020 Jan;109(1):690-695 | Siska C, Harber P, Kerwin BA. | 1/2/2020 | https://www.ncbi.nlm.nih.gov/pubmed/31689428 |
| Shipping | Evaluating & Qualifying Temperature Managed Shippers | ThermoFisher Scientific | Fisher Clinical Services | 7/1/2019 | https://vertassets.blob.core.windows.net/download/a8e43846/a8e43846-1647-430b-a4c3-0a387df13424/ebook_ctd_cold_chain_evaluating___qualifying_temperature_managed_shippers.pdf |
| Shipping | Qualification Versus Validation and Good Cold Chain Management Practices | Pharmaceutical Manufacturing and Packing Sourcer, Autumn 2005 issue, pages 102, 104, 106. © 2005 Samedan Ltd | Rafik H. Bishara | 9/1/2005 | https://www.semanticscholar.org/paper/Qualification-Versus-Validation-and-Good-Cold-Chain-Bishara/ec361b2c0183806848d124e9baa483344a5b0e0b |
| Shipping | A Stability Program for the Distribution of Drug Products | Pharmaceutical Technology JULY 2004 | Teresa I. Lucas, Rafik H. Bishara, and Robert H. Seevers | 7/1/2004 | https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.472.8007&rep=rep1&type=pdf |
| Shipping (new 2/2022) | Standardizing Best Practices For Transporting Cell And Gene Therapies | Cell & Gene | Mark Sawicki, Ph.D., Chief Commercial Officer, Cryoport, and Robert Jones, Vice President, Global Bioservices, Cryoport | 2/16/2022 | https://www.cellandgene.com/doc/standardizing-best-practices-for-transporting-cell-and-gene-therapies-0001?vm_tId=2388824&vm_nId=70481&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=Standardizing%20Best%20Practices%20For%20Transporting%20Cell%20And%20Gene%20Therapies&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_03-05-2022-wne&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=Standardizing%20Best%20Practices%20For%20Transporting%20Cell%20And%20Gene%20Therapies&mkt_tok=MDc1LU5WQy0wODYAAAGC-SN8NDV_B9DxXrTr4giSfGxtiI1ovX10m35kW1C9UWa2Tzt5GpHQ6xbmX0uXfJqf0jHYxp-YpNZrq0yoxBy4lX1XVP0KyqiIfs8PrS8C5Gwm |
| SOPs | Developing Effective Procedures | CAI E-Publication | Jeff Hall & Lisa Hawkins | 9/1/2021 | https://kenx.org/wp-content/uploads/2021/09/CAI_Developing-Effective-Procedures-Whitepaper.pdf?utm_source=Article%20Downloads&utm_medium=email&utm_campaign=Ops%20Readiness%205%20-%20Complimentary%20Webinar%20-%20Developing%20Effective%20Procedures%20%28UQdXer%29&_kx=SLU5Vpxfb_6kRxVDfKbeyHPkeZBC5DzHopYSspANdBg%3D.X3EpUs |
| Stability Concepts | Stability Studies and Testing of Pharmaceuticals - An Overview | LCGC NA V-38 I-6 p325-336 | Michael Dong, Kim Huynh-Ba | 6/1/2020 | https://www.chromatographyonline.com/view/stability-studies-and-testing-pharmaceuticals-overview |
| Stability Concepts | Effect of Drug Load and Surface Area on Degradation Rate in Solids | Sci of Stability Conference | Gary Scrivens | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Stability Concepts | An holistic approach to profound product understanding | Sci of Stability Conference | NA | 8/14/2019 | https://freethinktech.com/sos-2019-slide-presentations/ |
| Stability Concepts | How to Optimize Your Stability Program at Each Phase of Drug Development. | Pharmaceutical online | Michael W. Dong | 4/18/2017 | https://www.pharmaceuticalonline.com/doc/how-to-optimize-your-stability-program-at-each-phase-of-drug-development-0001 |
| Stability Concepts | Designing Phase-Appropriate Stability Study Programs for Drug Substances and Drug Products | Pharmaceutical Outsourcing | , Kim Huynh-Ba | 8/9/2018 | https://www.pharmoutsourcing.com/Featured-Articles/352619-Designing-Phase-Appropriate-Stability-Study-Programs-for-Drug-Substances-and-Drug-Products/ |
| Stability Concepts (new 1/22) | Developments in stability testing and evaluation | European Pharmaceutical Review | David Elder (JPAG Chair), Dr Conor Jamieson (Sandwell and West Birmingham NHS Trust), Dr Gary Scrivens (Pfizer), Dr Jonathan Bright (AstraZeneca), Dr Maria Krisch (FreeThink Technologies), Dr Paul Fullerton (AMRI), John Cleverley (Clarivate Analytics), Rachel Orr (GlaxoSmithKline), Susan Smith (AstraZeneca) | 9/4/2019 | https://www.europeanpharmaceuticalreview.com/article/98391/developments-in-stability-testing-and-evaluation/ |
| Stability Programs | Medical Product Stability Function Overview | CfPA Webinar | John O'Neill | 6/4/2018 | https://www.cfpa.com/CourseDescription/CourseDescription/220425VT2794/2794 |
| Stability Programs | Stability Testing – Doing Everything or Doing the Right Thing? | American Pharmaceutical Review | Jon V. Beaman | 8/1/2010 | https://www.americanpharmaceuticalreview.com/Featured-Articles/116169-Stability-Testing-Doing-Everything-or-Doing-the-Right-Thing/ |
| Stability Programs | Stability Studies and Testing of Pharmaceuticals: An Overview | International Pharmaceutical Academy | Kim Huynh-Ba & Michael W. Dong | 6/10/2020 | https://ipacanada.com/stability-studies-and-testing-of-pharmaceuticals-an-overview/ |
| Statistics | Establishing the Shelf Life of Pharmaceutical Products (PDF) | pqri.org stability shelf life | PQRI Stability-shelf-life Working Group | 7/8/2008 | http://pqri.org/stability-shelf-life-working-group/ |
| Statistics | Statistical Considerations for Stability and the Estimation of Shelf Life | Chapter from book Nonclinical Statistics for Pharma & Biotech Industries (pp.575-604) | Walter W. Stroup, Michelle Quinlan | 1/1/2016 | https://www.springer.com/gp/book/9783319235578 |
| Statistics | Statistical Process Control and the Use of Control Charts Using Statistics to Identify and Understand Procss Capability, Stability and Control | KENX Library | Douglas B. Brown | 6/17/2019 | https://www.kenx.org/wp-content/uploads/2019/08/32_DBrown_KENX-2019-Philadelphia-Stab-Test-Prog-Mngmnt-Day-3-1030AM-DBB5-2-1.pdf |
| Statistics (new 11/21) | Deploying SASÆ as the Cornerstone of a Stability Monitoring Program: | Abbott Laboratories Paper #PH07 | Jeff Gardner | 11/12/2021 | https://mwsug.org/proceedings/2006/pharma/MWSUG-2006-PH07.pdf |
| Statistics | Stability Shelf Life Working Group-Product Quality Research Institute | pqri.org stability shelf life | PQRI Stability-shelf-life Working Group | 7/8/2008 | http://pqri.org/stability-shelf-life-working-group/ |
| Statistics | SSLWG Glossary Version 1.0 (PDF) | pqri.org stability shelf life | PQRI Stability-shelf-life Working Group | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/SSLWG_Glossary_Ver_1-0.pdf |
| Statistics | PQRI SSL WG Update Webinar Presentation – 08 July 2008 (PDF) | pqri.org stability shelf life | Schwenke, Forenzo, Stroup | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/PQRI_SSL_WG_Webinar_Presentation_-_08_July_2008.pdf |
| Statistics | Direct Approaches to Shelf Life Estimation (Presentation Slides) (PDF) | pqri.org stability shelf life | Quinlan, Schwenke, Stroup | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/JSM_2008_-_Michelle_Presentation.pdf |
| Statistics | Direct Approaches to Shelf Life Estimation (Poster) (PDF) | pqri.org stability shelf life | Quinlan, Schwenke, Stroup | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/Quinlan_-_Poster_-_Shelf_Life_Estimation.pdf |
| Statistics | Evaluating Tolerance Interval Estimates: To Capture or Not to Capture (Slides) (PDF) | pqri.org stability shelf life | Quinlan, Schwenke, Stroup | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/Quinlan_-_Presentation_-_Tolerance_Intervals.pdf |
| Statistics | Proposed Methodology for Shelf Life Estimation (Presentation Slides) (PDF) | pqri.org stability shelf life | Quinlan, Schwenke, Stroup | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/2009_MBSW.pdf |
| Statistics | Estimating Shelf Life Using Quantile Regression with Random Batch Effects (Slides) (PDF) | pqri.org stability shelf life | Quinlan, Schwenke, Stroup | 8/5/2009 | http://pqri.org/wp-content/uploads/2016/07/JSM_2009_v3.pdf |
| Statistics | Comparing Statistical Interval Estimates (Presentation Slides) (PDF) | pqri.org stability shelf life | Quinlan, Schwenke, Stroup | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/2008_ENAR.pdf |
| Statistics | Reconsidering Shelf Life: An Update from the PQRI Stability Shelf Life WG (Slides/PDF) | pqri.org stability shelf life | Schwenke, Forenzo | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/2008_MBSW_Presentation.pdf |
| Statistics | Non-Clinical Statistics Conference:Update from the PQRI Stability Shelf Life WG Slides/PDF | pqri.org stability shelf life | Schwenke | 9/23/2008 | http://pqri.org/wp-content/uploads/2016/07/2008_Nonclinical_Meetings_-_Belgium.pdf |
| Statistics | Shelf Life Determination: The PQRI Stability Shelf Life WG Initiative (Slides/PDF) | pqri.org stability shelf life | PQRI Stability-shelf-life Working Group | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/2009_FDA-Industry_Workshop_Panel_Discussion.pdf |
| Statistics | New Approaches to Stability Testing (Presentation Slides) (PDF) | pqri.org stability shelf life | PQRI Stability-shelf-life Working Group | 7/8/2008 | http://pqri.org/wp-content/uploads/2016/07/2009_PhRMA_Leaders_Meeting_-_Shelf_Life.pdf |
| Statistics | Are You Uncertain About Uncertainty? | IVT Jr GXP Compliance Vol 22 Issue 6 | William Porter | 5/30/2017 | http://www.ivtnetwork.com/article/are-you-uncertain-about-uncertainty |
| Statistics (new 11/21) | Analyzing Data From Stability Studies | Statgraphics Technologies Inc | Neil Polhemus | 1/27/2021 | https://www.youtube.com/watch?v=4Gv3y2vwXes |
| Sterility | Sterilization and Sterility Assurance in Medical Device Packaging | IVT Voices in Validation Podcast | Roberta Goode | 3/2/2021 | https://www.ivtnetwork.com/article/sterilization-and-sterility-assurance-medical-device-packaging |
| Therapeutics | The Cryopreservation Process And Its Impact On The Consistency Of High-Quality Cell Therapy Products | Cell & Gene | Sam Molina, Peter Kilbride | 1/12/2022 | https://www.cellandgene.com/doc/the-cryopreservation-process-and-its-impact-on-the-consistency-of-high-quality-cell-therapy-products-0001?vm_tId=2387585&vm_nId=70304&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=The%20Cryopreservation%20Process%20And%20Its%20Impact%20On%20The%20Consistency%20Of%20High-Quality%20Cell%20Therapy%20Products&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL-Cytiva-CRYO2-ABM3&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=The%20Cryopreservation%20Process%20And%20Its%20Impact%20On%20The%20Consistency%20Of%20High-Quality%20Cell%20Therapy%20Products&mkt_tok=MDc1LU5WQy0wODYAAAGDeolNC4We7-zYzQj5Xj0hdhVbnCWSYu6gnQK77G0joQWFInnHz-NerpihfVWkx9zgWj1VU7JueTjL1n40EDSrbFF11IML2XNczjpvO1YvtVCj |
| Therapeutics | The Science of Cell Therapy Thawing | Cell & Gene | Cytiva | 1/12/2022 | https://www.cellandgene.com/doc/the-science-of-cell-therapy-thawing-0001 |
| Therapeutics | The Big (Bio) Freeze | Cell & Gene | Cytiva John Morris | 1/12/2022 | https://www.cellandgene.com/doc/the-big-bio-freeze-0001 |
| Therapeutics | Shipping Temperatures for Cell Therapies | Cell & Gene | Julie Meneghel, Peter Kilbride, Bill Shingleton, Alex Nancekievill, John Morris, Cytiva | 1/12/2022 | https://www.cellandgene.com/doc/shipping-temperatures-for-cell-therapies-0001 |
| Therapeutics | Are Real-Time Gene Therapy Test Results Possible? | Cell & Gene | Sean Hart, Bhargava Kondragunta | 4/4/2022 | https://www.cellandgene.com/doc/are-real-time-gene-therapy-test-results-possible-0001?vm_tId=2397821&vm_nId=70888&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=Are%20Real-Time%20Gene%20Therapy%20Test%20Results%20Possible%3F&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_04-04-2022-CatalentC%26G&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=Are%20Real-Time%20Gene%20Therapy%20Test%20Results%20Possible%3F&mkt_tok=MDc1LU5WQy0wODYAAAGDk6MuHF0giy_7sValf_8wgfMGc4WXwM397XR0C1seoAqtzYtzNQIvWQh1EUMdJ77mG78MNkGXTeroj2AV35R5GHJ_bWpcqAiQypg-GvtaDUHO |
| Therapeutics | Navigating The Path To The Clinic And Beyond For Gene Therapies | Cell & Gene | Denise Krohn, Ann McMahon | 4/4/2022 | https://www.cellandgene.com/doc/navigating-the-path-to-the-clinic-and-beyond-for-gene-therapies-0001?vm_tId=2397823&vm_nId=70888&user=b0b5fe6b-ff29-4063-822b-eda8c334f354&gdpr=0&vm_alias=Navigating%20The%20Path%20To%20The%20Clinic%20And%20Beyond%20For%20Gene%20Therapies&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_04-04-2022-CatalentC%26G&utm_term=b0b5fe6b-ff29-4063-822b-eda8c334f354&utm_content=Navigating%20The%20Path%20To%20The%20Clinic%20And%20Beyond%20For%20Gene%20Therapies&mkt_tok=MDc1LU5WQy0wODYAAAGDk6MuHJKQlpeHF54G0oWNaBHOicFtIOo6RPRXL88hbICd4M763rUamP6_YAferwMrCp8fsAxQSDRWRwg6WHwRbpoQ4daZ4_luCpG_HHmLtRxE |
| Therapeutics | A Strategy To Remove Formulation Development From The Critical Path During Biologics Developmen | Cell & Gene | Lu | 4/4/2022 | https://www.cellandgene.com/doc/a-strategy-to-remove-formulation-development-from-the-critical-path-during-biologics-development-0001 |
| Therapeutics | Cell Therapy Logistics | ThermoFisher Scientific | Not disclosed | 4/9/2022 | https://vertassets.blob.core.windows.net/download/b18a658a/b18a658a-d286-4ac4-bf22-f3558de3b5b7/cell_therapy_logistics_ebook.pdf |
| Therapeutics | Shipping anf Logistics Considerations for Regenerative Medicine Therapies | Stem Cells Translational Medicine | Tracy Criswell, Corne Swart, Jana Stoudemire, Kelvin Brockbank, Michael Floren, Shannon Eaker, Joshua Hunsberger | 3/5/2022 | https://academic.oup.com/stcltm/advance-article/doi/10.1093/stcltm/szab025/6542876 |
| Therapeutics | How To Overcome Potency Assay Development Challenges For Gene Therapies | Cell & Gene | Biophorum | 4/22/2022 | https://www.cellandgene.com/doc/how-to-overcome-potency-assay-development-challenges-for-gene-therapies-0001?vm_tId=2408823&vm_nId=71535&user=b7751aa8-548e-48f7-9c46-798f102f8549&gdpr=0&vm_alias=How%20To%20Overcome%20Potency%20Assay%20Development%20Challenges%20For%20Gene%20Therapies&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_05-03-2022&utm_term=b7751aa8-548e-48f7-9c46-798f102f8549&utm_content=How%20To%20Overcome%20Potency%20Assay%20Development%20Challenges%20For%20Gene%20Therapies&mkt_tok=MDc1LU5WQy0wODYAAAGEKN-6ijBFG7B1tIAh105H0raazHZy46o6SR0FLYKiC5UvhhbvwvcIuOihfxJGJJQty2nO5oXfBfUIvQVCyNrN1ryKq8AKsfVXZlbRRugTzU5qEw |
| Therapeutics | Future Proofing Peptide MAM By Ensuring Scalability And Deployment | Cell & Gene | Scott Berger Waters Inc | 2/22/2022 | https://www.cellandgene.com/doc/biopharma-s-future-next-generation-lc-ms-workflows-for-peptide-mam-0001?vm_tId=2408826&vm_nId=71535&user=b7751aa8-548e-48f7-9c46-798f102f8549&gdpr=0&vm_alias=Future-Proofing%20Peptide%20MAM%20By%20Ensuring%20Scalability%20And%20Deployment&utm_source=mkt_CELL&utm_medium=email&utm_campaign=CELL_05-03-2022&utm_term=b7751aa8-548e-48f7-9c46-798f102f8549&utm_content=Future-Proofing%20Peptide%20MAM%20By%20Ensuring%20Scalability%20And%20Deployment&mkt_tok=MDc1LU5WQy0wODYAAAGEKN-6itSAHHHGXBipqYc5ngg3u3c12pjbwvU8J-omJtZzk45DMZHIKIFUk-FRgGfRO3mjmAy5UzAj6JaIliNnQa-UefMjO4jJGD9kU3tIw5Vmhg |
| Toxics | Death by Licorice? Unexpected Toxicity From Drug Products | IVT Jr GXP Vol 25 Issue 2 | Paul Pluta | 3/9/2021 | https://www.ivtnetwork.com/article/death-licorice-unexpected-toxicity-drug-products-0 |
| Training & Education | Best Practices in training | IVT Jr GXP Compliance Vol 22 Issue 6 | Lorianne Richter, Anne Greene | 9/19/2019 | http://www.ivtnetwork.com/article/understanding-adult-learning-principles-cgmp-training-modalities-and-pharmaceutical-regulato |
| Validation | Writing Pharmaceutical Equipment Qualification Protocols | IVT Jr GXP Compliance Vol 22 Issue 5 | Joe Cagnassola, Paul Copus, Keith Haynes | 9/24/2018 | http://www.ivtnetwork.com/article/writing-pharmaceutical-equipment-qualification-protocols |
| Validation | Application Of Wireless Technology In The Pharmaceuticals Sector: Maintaining Data Integrity, Security And Privacy | IVT Jr GXP Compliance Vol 24, Issue 3 | Tim Sandle | 5/26/2020 | https://www.ivtnetwork.com/article/application-wireless-technology-pharmaceuticals-sector-maintaining-data-integrity-security-a |
| Validation | Integrated PQ Documents | IVT Jr ValTech Vol 27, Issue 1 | Paul Pluta | 2/23/2021 | https://www.ivtnetwork.com/article/pq-forum-19-integrated-pq-documents |
| Validation | Connected Device System Validation & Quality - Best Practices | IVT Jr Val Tech | Carolyn Wright | 8/28/2017 | https://www.ivtnetwork.com/article/connected-device-system-validation-quality-best-practices |
| Validation | Keeping Validation Functional and Productive During a Pandemic | IVT Jr Val Tech | Ivan Soto | 2/23/2021 | https://www.ivtnetwork.com/article/keeping-validation-functional-and-productive-during-pandemic |
| Validation | FAQ – Statistics in Validation | IVT Jr Val Tech | Roberta Goode | 7/5/2017 | https://www.ivtnetwork.com/article/faq-statistics-validation |
