· 2018
Analytical Method Development and Validation
- 547citations
- 2018year
Short summary
This paper details the process of developing and validating analytical methods, particularly in high-performance liquid chromatography (HPLC), providing examples and outlining regulatory guidelines from agencies like the FDA and ICH.
AI-generated from the title and abstract; the full text is not read.
Key points
- Details the process of analytical method development and optimization.
- Provides examples of successful method development and validation in HPLC.
- Summarizes FDA, ICH, and US Pharmacopeia regulatory guidelines for validation.
- Emphasizes compliance with validation requirements for regulatory agencies.
AI-generated from the title and abstract; the full text is not read.
Abstract
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.
The authors' abstract, as published at the source., 2018 · DOI ↗
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Field: Analytical Chemistry
Analytical ChemistryChemistry