stability-testing-study-design

Stability Testing Study Design and Data Evaluation to Support a Clinical Study in the European Union: Part 2

By |2021-10-13T17:01:31-04:00March 15th, 2021|

This blog post is Part 2 of the series and comes to us from Piero De Filippis, StabilityHub EU Regional Contributor, Verona (Italy). Introduction This blog reports key points to consider when assigning or extending a retest period (RP) or a shelf-life (SL) to a drug substance (DS, i.e. an API) or to the related [...]

Stability Testing Study Design and Data Evaluation to Support a Clinical Study in the European Union: Part 1

By |2021-10-13T17:01:21-04:00February 28th, 2021|

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 directive 2001/20/EC (Ref.1a) defines an Investigational Medicinal Product (IMP, also known in USA as ‘Investigational Drug Product’ (Ref.2&3)) as “a pharmaceutical [...]

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