
Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
Mary Ann Gorko is principal statistician at AstraZeneca.

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

Representatives from PhRMA member companies discuss the growing concern about out-of-trend stability data, including possible statistical approaches and the implementation challenges to identifying OOT results.

Published: April 2nd 2003 | Updated:

Published: October 2nd 2018 | Updated: