The development of a generic formulation requires replicating a reference formulation in both content and conduct. This includes mimicking the release rate of the active as characteristic of the formulation. IVRT (in vitro Release Testing) provides a convenient and reliable tool to measure the release rate of topical formulations and hence, is uniquely qualified to establish bioequivalence. Developing an IVRT assay can be challenging, particularly for actives with low solubility and formulations that release slowly. In addition, biases in method design can lead to flawed testing and misleading conclusions, delaying the development and approval of the drug.
The webinar will discuss the principles and procedures for method development and validation of an IVR test. It will also describe the method for testing for bioequivalence, including the statistical analysis involved. The regulatory requirements and the common deficiencies for each step will also be detailed out.
Additional applications, such as site transfer, post-approval changes, use as a QC parameter for batch release and stability monitoring will also be described. In addition, the webinar will cover the challenges experienced during the development and testing stages and the subsequent troubleshooting. Furthermore, our successes with such challenging formulations at CPL will be detailed out. IVRT is likely to become mandatory for regulatory submissions in the future.
Therefore, a critical understanding of the technique is both essential and highly advantageous. This webinar aims at providing this comprehensive knowledge and practical guidance for the testing.
Key Learning Objectives
- To learn about the relevance and application of IVRT in topical drug development
- To learn about developing, validating, and conducting an IVRT assay
- To learn about the regulatory requirements for IVRT and the common deficiencies
- To learn about the challenges in performing IVRT and troubleshooting approaches
- Head/Leader of Research & Development
- Product Development
- Formulation Development
- Quality Control
- Dermatology Products & Drugs
- Scientists, Researchers, Clinicians and Regulatory affairs professionals interested in developing or conducting IVRT
- Topical drug development company, Groups & Stakeholders