Bioanalytics – Chemical
2019 PharmSci 360
Bioanalytical Method Validation Guidance for Industry provides FDA’s recommendations on the development, validation and in-study use of bioanalytical methods for the quantitative evaluation of drugs and their metabolites. Understanding the assessor’s perspective on the assessment of bioanalytical data submitted in Abbreviated New Drug Applications (ANDA’s) will help the applicants to submit quality data for their drug product approval. The presentation will provide an overview of important aspects of Bioanalytical method validation guidance and what OGD assessors look for in conducting the review of generic drug applications. Case study examples on review related issues during method validation and in-study analysis of ANDAs will be provided.