Analytical Method Development and Validation

• Publisher: CRC

• Number Of Pages: 96
• Publication Date: 1997-05-16
• Sales Rank: 567067
• ISBN / ASIN: 0824701151
• EAN: 9780824701154
• Binding: Paperback
• Manufacturer: CRC
• Studio: CRC
• Average Rating: 3.5
• Total Reviews: 2

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Book 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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