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Specification of Drug Substances and Drug Products is a fully comprehensive reference onSpecification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline...
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...
This volume reflects the changes that have taken place in the pharmaceutical industry over the last ten years, most notably the increased importance attached to the question of chirality, the growing influence of biotechnology and the need for more rigorous...
Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate...
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method,...
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