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