Sujata Syam, Ph.D. possesses over twenty years’ experience in the fields of Proteins, Assay Development and Therapeutics. Sujata joined CPL in 2015 as head of the Skin Lab and has been leading a group of scientists in developing topical testing techniques such as IVRT, IVPT, and skin-model-based testing. In the attached webinar (see below), Sujata discusses:
- The principles and procedures for method development and validation of in vitro release tests
- The method for testing for bioequivalence, including the statistical analysis involved
- Regulatory requirements and common deficiencies for each step
- Challenges and troubleshooting during the development and testing stages
- CPL’s successes and findings with challenging formulations
- Additional applications, such as: site transfers, post-approval changes, use as a QC parameter for batch release, and stability monitoring
IVRT is likely to become mandatory for regulatory submissions in the future. Therefore, an understanding of the technique is critical.