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Specification of Drug Substances and Products: Development and Validation of Analytical Methods
Paperback
ISBN13: 9780443134661
Publisher: Elsevier
Published: Sep 25 2024
Pages: 908
Weight: 4.55
Height: 1.80 Width: 8.50 Depth: 11.00
Language: English
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.
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