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Draft Guideline on Bioanalytical Method Validation in ...
Draft Guideline on Bioanalytical Method Validation in pharmaceutical development 15 April 2013, MHLW, Japan) 2 Table of Contents 1. Introduction 2. Scope 3. Reference Standard 4. Analytical Method Validation Full Validation Selectivity Lower limit of quantification Calibration curve Accuracy and precision Matrix effect Recovery Carry-over Dilution integrity Stability Partial Validation Cross Validation 5. Analysis of Study Samples Validity and reproducibility of analytical Method in analysis of study samples Calibration curve QC samples Incurred samples reanalysis (ISR) Carry-over Points to note Calibration range Reanalysis Chromatogram Integration System suitability 6. Documentation and Archives List of Relevant Guidelines Glossary Annex 3 1. Introduction 1 2 In the development of medicinal products, Bioanalytical methods are used in clinical 3 and non-clinical pharmacokinetic studies (including toxicokinetic studies) to evaluate 4 the efficacy and safety of drugs and their metabolites.
Draft Guideline on Bioanalytical Method Validation in Pharmaceutical Development （15 April 2013, MHLW, Japan)
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