Specification of Drug Substances and Products - 9780081028247

Specification of Drug Substances and ProductsDevelopment and Validation of Analytical Methods\nAuthor(s): Christopher M. Riley, Thomas W. Rosanske, George L. Reid\nFormat: Paperback\nPublisher: Elsevier Health Sciences, United Kingdom\nImprint: Elsevier / The Lancet\nISBN-13: 9780081028247, 978-0081028247\nSynopsis\nSpecification 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, ge.