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Following the April 28, 2021 Japanese GMP ordinance outlined in a previous StabilityHub Newsletter, further rules and regulations contained in the Japanese Pharmaceutical and Medical Device Act were initiated on August 1, 2021, For [...]
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Introduction and Background The storage of a bulk drug product is defined by the European Medicines Agency (EMA), with main reference to oral solid dosage forms (e.g., tablet cores before coating or packaging), but [...]
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Introduction Part 1 of this blog (Ref. 1) has described at a high level the guidance provided by the European Medicines Agency (EMA) on in-use stability testing of multi-dose products for human use (Ref. [...]
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With a high percentage of API’s sensitive to moisture, the moisture-barrier characteristic of a pharmaceutical packaging is gaining greater prominence. Within this article, LOG presents insights about WVTR testing and its specially designed moisture-barrier [...]
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Introduction ANVISA, the Brazilian human health regulatory authority, has issued in recent years a number of documents describing in detail what is expected to be presented in a Regulatory submission in Brazil for Forced [...]
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Introduction In recent years, the Brazilian human health regulatory authority ANVISA, has issued a number of documents describing in detail what is expected to be presented in a Regulatory submission in Brazil for Forced [...]
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Introduction ANVISA, the Brazilian human health regulatory authority, has issued in the recent years a number of documents describing in detail what is expected to be presented on Forced Degradation Studies and how they [...]
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This blog post is Part 1 of the series and comes to us from Piero De Filippis, StabilityHub EU Regional Contributor, Verona (Italy). Part 1: Stability Study Design for an Investigational Medicinal Product European [...]
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February 19 has been proposed as a national day to recognize the process, as well as the scientists who conduct the experiments to determine the stability of medical products, which results in the prescribed [...]
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Is there something to be thankful for in the midst of a pandemic that is threatening our families and our life savings too? Well, not for those things, but a life-threatening force sure has [...]
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