Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics
Reference56 articles.
1. Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan F, Zhao Y, Kotzagiorgis E, et al. Applications of physiologically based biopharmaceutics modeling (PBBM) to support drug product quality: a workshop summary report. J Pharm Sci. 2021;2:594–609. https://doi.org/10.1016/j.xphs.2020.10.059.
2. Yuvaneshwari K, Kollipara S, Ahmed T, Chachad S. Applications of PBPK/PBBM modeling in generic product development: an industry perspective. J Drug Del Sci Technol. 2022;69:103152. https://doi.org/10.1016/j.jddst.2022.103152.
3. USFDA guidance for industry. The use of physiologically based pharmacokinetic analyses—biopharmaceutics applications for oral drug product development, manufacturing changes, and controls guidance for industry. Oct 2020. https://www.fda.gov/media/142500/download, Accessed 09th Sep 2022
4. Gray VA, Mann JC, Barker R, Pepin XJH. The case for physiologically based biopharmaceutics modelling (PBBM): what do dissolution scientists need to know? Dissolution Technol. 2020. https://doi.org/10.14227/DT270320P6
5. USFDA guidance for industry. Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation. Aug 2018. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-simulation_en.pdf. Accessed 09th Sep 2022
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