ANCOVA Approach: Premarketing Shelf Life Determination with Multiple Factors

Authored by: Yi Tsong , Chi-wan Chen , Wen Jen Chen , Roswitha E. Kelly , Daphne T. Lin , Karl K. Lin

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-130001015

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Abstract

The stability of a drug substance or drug product is its capacity to remain within the established acceptance criteria to ensure its identity, strength, quality, and purity for a specified period of time. In this entry, the discussion focuses on the shelf life determination based on ANCOVA modeling.

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