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DISSO INDIA 2021
June 24, 2021 - June 26, 2021
In collaboration with the American Association of Pharmaceutical Scientists (AAPS), the Scientific Committee for DISSO INDIA has organized the 10th Annual International Conference on Dissolution Science and Applications – “Dissolution as a Pivotal Tool for Drug Product Performance” this conference will be held online June 24th-26th.
Dr. Sandra Suarez-Sharp, Vice President of Regulatory Affairs, will present on June 25th.
Simulations Plus DISSO India-2021 Online, International Symposium June 25, 2021
The Application of Physiologically based Biopharmaceutics Modeling (PBBM) in Support of Biopredictive Dissolution Method Development Sandra Suarez-Sharp
Drug product development continues to be a costly enterprise despite ongoing efforts across pharmaceutical companies to rein in growing R&D costs. In the case of complex generics, demonstration of bioequivalence (BE) relies, for the most part, on costly and lengthy unconventional in vivo BE studies, which contribute to a significant cost burden to the healthcare system.
To facilitate drug product development and the approval process, regulatory agencies (i.e., FDA) have published several guidance documents for industry, including drug product specific guidance and the recently available draft guidance on the use of physiologically based pharmacokinetic analysis-biopharmaceutics applications for oral drug product development, manufacturing changes and control (also known as physiologically based biopharmaceutics modeling (PBBM)). PBBM can accelerate drug product development by informing the design of formulation and process, the design of BE clinical study, etc. However, a rational, science-based approach to incorporating biopredictive dissolution into PBBM is key as industry seeks to use modeling to gain manufacturing and regulatory flexibility. This presentation will focus on: 1) The impact of biopredictive dissolution methods in drug product development and lifecycle management; 2) A general work flow of PBBM development and validation; 3) The application of PBBM to support the assessment and mitigation of risk including informing the development of biopredictive dissolution methods.
Newly added presentation from Jim Mullin, download his slides here.