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{
"item_title" : "Analytical Method Development and Validation",
"item_author" : [" Michael E. Swartz "],
"item_description" : "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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Analytical Method Development and Validation
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Overview
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.
This item is Non-Returnable
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Details
- ISBN-13: 9780824701154
- ISBN-10: 0824701151
- Publisher: CRC Press
- Publish Date: May 1997
- Dimensions: 8.18 x 5.96 x 0.19 inches
- Shipping Weight: 0.28 pounds
- Page Count: 96
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