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Specification of Drug Substances and Products

Development and Validation of Analytical Methods

3rd Edition - July 1, 2024

Editors: Christopher M. Riley, K. Lien Nguyen

Language: English
Paperback ISBN:
9 7 8 - 0 - 4 4 3 - 1 3 4 6 6 - 1
eBook ISBN:
9 7 8 - 0 - 4 4 3 - 1 3 4 6 7 - 8

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the unive… Read more

Specification of Drug Substances and Products

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Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the second edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products.