PMXAC2025 - Session 2: BA-BE for Africa: Innovation and Regulatory Impact скачать в хорошем качестве

PMXAC2025 - Session 2: BA-BE for Africa: Innovation and Regulatory Impact

(Chairs: Phumla Sinxadi and Natalie) In this session, experts will discuss how bioavailability and bioequivalence (BA-BE) studies ensure the safety and effectiveness of generic medicines, a major priority in Africa, where generics account for over 95% of all medicines. Typically based on easy-to-implement analysis methods like non-compartmental analysis (NCA), pharmacometricians often down-play the importance of these techniques. Presentations will highlight how advances in AI, including large language models, can boost the speed, accuracy, and efficiency of BA-BE evaluations. 20:30 Innovation in open-source tools for bioequivalence evaluations, PKNCA and more Bill Denney 51:02 Leveraging AI and Large Language Models for BA-BE Dossier Assessment Mahlodi Maropa 1:12:45 Model-Based Bioequivalence: The Key to Unlocking Regulatory Pathways for Complex Generics Mahmoud Ali Afifi