Expiration Dating Period

Authored by: Annpey Pong

Encyclopedia of Biopharmaceutical Statistics

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

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-130001077

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Abstract

The expiration dating period (or shelf-life) of a drug product is defined as the time interval that the characteristics of the product will remain within the approved specification limits after manufactured. This entry focuses on the methods of determining the expiration dating period of a drug product and the regulatory requirements that influence this decision.

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