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Specification of Drug Substances and Products: Development and Validation of Analytical Methods

By Christopher M. Riley PhD (Editor), K. Lien Nguyen Ph.D (Editor)
eBook
$275.00
By Christopher M. Riley PhD (Editor), K. Lien Nguyen Ph.D (Editor)
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Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals.

There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines.

This edition contains chapters discussing the unique requirements for the universal critical quality attr...

Categories

Science & TechnologyChemistryAnalytical ChemistryAnalytical Chemistry - General & Miscellaneous