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Book Detail

Title Analytical Method Development and Validation  
Author Michael E. Swartz  Publisher
CRC
Category Pharmaceutical Spl price  Year
1997
Price 25.99  ISBN
9780824701154
Picture  
Notes Summary Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH. 
 

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