Claire Mackie, Sumit Arora, Paul Seo, Rebecca Moody, Bhagwant Rege, Xavier Pepin, Tycho Heimbach, Christer Tannergren, Amitava Mitra, Sandra Suarez-Sharp, Luiza Novaes Borges, Shinichi Kijima, Evangelos Kotzagiorgis, Maria Malamatari, Shereeni Veerasingham, James E Polli, Gregory Rullo
Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application. Currently, only one country has a draft guidance document for PBBM, whereas other major regulatory authorities have had limited experience with the review of PBBM...
April 10, 2024: Molecular Pharmaceutics