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Evolution of Analytical Methods from Pre-clinical Phase Through Registration-Ensuring Method Performance and Regulatory Compliance
Wednesday, November 14
8:30 am – 11:00 am
Wednesday Morning Symposia are Funded by a Grant from
Symposium
ACPE #073-999-07-522-L04
Analytical methodologies for drug substances and drug products evolve from the early stage methods in pre-clinical development through Phase 1 methods and through development stages resulting in final registration methods. During the various phases of drug development, knowledge is gained regarding impurities and degradation products, drug substance manufacturing process and the synthetic steps change, formulations and drug product manufacturing process evolve. The analytical methods evolve in parallel to meet the drug development needs at all stages. Significant insight about the drug substance and drug product is obtained from the stability evaluation of the clinical and development batches of drug substances and drug products. In addition, valuable insights are obtained regarding the performance of the analytical methods from the stability evaluations of the clinical and development batches. This symposium will discuss the critical aspects of evolution of analytical methods, approaches to phase-appropriate validation of analytical methods including non-chromatographic methods and approaches to manage post-approval method changes to meet current regulatory standards.
Moderator
Dilip R. Choudhury, Ph.D.
Scios, Inc./Johnson & Johnson
Analytical Methods Validation Approaches From Early Phase Through Registration
Ganapathy Mohan, Ph.D.
Sanofi-Aventis
Evolution of Analytical Methods from Pre-clinical through Registration Phases – Ensuring Performance of the Methods to Facilitate Accelerated Drug Development
Dilip R. Choudhury, Ph.D.
Scios, Inc./Johnson & Johnson