Analytical Method Development 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. 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.--provided By Publisher.