Analytical Method Development and Validation

Analytical Methods Development, Optimization, and Validation

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas.

Regulatory Guidelines and Compliance

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 Pharmacopoeia, FDA and ICH.