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Specification of Drug Substances and Products : Development and Validation of Analytical Methods , 2nd Edition (Original PDF from Publisher)
47$
Product Details
- Item Weight : 2.92 pounds
- Paperback : 694 pages
- ISBN-10 : 0081028245
- ISBN-13 : 978-0081028247
- Product Dimensions : 7.5 x 1.39 x 9.25 inches
- Publisher : Elsevier : 2nd Edition (August 7 , 2020)
- Language : English
Description
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)
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