Publisher
Springer Science and Business Media LLC
Reference20 articles.
1. Loisios-Konstantinidis I, Cristofoletti R, Fotaki N, Turner DB, Dressman J. Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. Case example: Naproxen. Eur J Pharm Sci Off J Eur Fed Pharm Sci. 2020;143:105170. https://doi.org/10.1016/j.ejps.2019.105170.
2. Pepin XJH, Parrott N, Dressman J, Delvadia P, Mitra A, Zhang X, et al. Current state and future expectations of translational modeling strategies to support drug product development, manufacturing changes and controls: a workshop summary report. J Pharm Sci. 2020. https://doi.org/10.1016/j.xphs.2020.04.021.
3. FDA. Guidance for Industry. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. https://collections.nlm.nih.gov/catalog/nlm:nlmuid-101720038-pdf Accessed August 9 2022. 2017.
4. FDA. Guidance for Industry. Dissolution testing of immediate release solid oral dosage forms. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dissolution-testing-immediate-release-solid-oral-dosage-forms Accessed August 9 2022. 1997.
5. Grimstein M, Yang Y, Zhang X, Grillo J, Huang SM, Zineh I, et al. Physiologically based pharmacokinetic modeling in regulatory science: an update from the U.S. Food and Drug Administration’s Office of Clinical Pharmacology. J Pharm Sci. 2019;108(1):21–5. https://doi.org/10.1016/j.xphs.2018.10.033.
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献