Specification of Drug Substances and Products

Presents a critical analysis of the requirements and approaches to setting specifications for the new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This title offers a guide to industry practices of analytical methodologies used in t [...]
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Presents a critical analysis of the requirements and approaches to setting specifications for the new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This title offers a guide to industry practices of analytical methodologies used in the specification of drug substances and products.