Publisher
Springer Science and Business Media LLC
Reference51 articles.
1. Guidance FDA. Statistical approaches to establishing bioequivalence. Rockville, MD: US Food and Drug Administration. Center for Drug Evaluation and Research (CDER); 2001.
2. GUIDANCE FDA. The use of physiologically based pharmacokinetic analyses—biopharmaceutics applications for oral drug product development, manufacturing changes, and controls. Rockville, MD: US Food and Drug Administration. Center for Drug Evaluation and Research (CDER); 2020.
3. Stillhart C, Pepin X, Tistaert C, Good D, Van Den Bergh A, Parrott N, Kesisoglou F. PBPK absorption modeling: establishing the in vitro–in vivo link—industry perspective. AAPS J. 2019;21:1–13.
4. Zhuang X, Lu C. PBPK modeling and simulation in drug research and development. Acta Pharmaceutica Sinica B. 2016;6(5):430–40.
5. Darwich AS, Neuhoff S, Jamei M, Rostami-Hodjegan A. Interplay of metabolism and transport in determining oral drug absorption and gut wall metabolism: a simulation assessment using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” model. Curr Drug Metab. 2010;11(9):716–29.