Specification of Drug Substances and Products: Development and Validation of Analytical Methods 2nd Edition – Ebook Instant Download/Delivery ISBN(s): 9780081028247,0081028245, 9780081028254, 0081028253

Product details:

• ISBN-10: 0081028253
• ISBN-13: 9780081028254
• Author: Christopher M. Riley, Thomas W. Rosanske, George L. Reid

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.

Table contents:

I – Introduction

II – Universal tests

III – Specific tests: drug substances

IV – Specific tests: Drug product

V – Biotechnology products

VI – Pharmacopeial methods

VII – Biological fluids

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