Analytical method development and validation
著者
書誌事項
Analytical method development and validation
Marcel Dekker, c1997
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注記
Bibliography: p. 85-92
内容説明・目次
内容説明
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.
目次
- Method development, optimization and validation approaches
- method validation (USP/ICH)
- system suitability
- method validation protocol
- method transfer and revalidation.
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