FDA Expectations for Shelf Life Prediction in NDAs and ANDAs
Predicting shelf life accurately is a regulatory cornerstone of every New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) filed with the USFDA. The agency’s expectations have evolved to demand greater statistical rigor, especially in interpreting stability data using ICH Q1E-based models. This tutorial-style guide provides a comprehensive overview of what FDA reviewers look…
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