Specification of Drug Substances and Products : Development and Validation of Analytical Methods , 2nd Edition (Original PDF from Publisher)

Specification of Drug Substances and Products : Development and Validation of Analytical Methods , 2nd Edition (Original PDF from Publisher)

With an emphasis on phase-appropriate development , validation of analytical methods and their practical application , the second edition of Specification of Drug Substances and Products : Development and Validation of Analytical Methods provides a thorough and critical analysis of the requirements and methods for setting specifications for new pharmaceutical products . Topics like method development and validation in the clinical phase , method transfer , process analytical technology , analytical life cycle management , unique challenges with generic drugs , genotoxic impurities , topical products , nasal sprays and inhalation products and biotechnology products are all covered in this extensively revised second edition . The authors of the book have been carefully chosen as subject-matter experts in business , academia and government laboratories , as well as previous membersof the ICH Expert Working Groups responsible for producing the ICH guidelines .

see also : Progress in Medicinal Chemistry (Volume 59) (Original PDF from Publisher)