Specifications

Authored by: John R. Murphy

Encyclopedia of Biopharmaceutical Statistics

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

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-130001200

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Abstract

Specifications on the physical and chemical attributes of drug substances and drug products are the quality standards that provide the patient assurance that the drug will perform its intended purpose without unexpected side effects. This entry gives a brief overview of how these specifications are determined.

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