Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?

Author:

Gomez-Mantilla Jose David,Huang Fenglei,Peters Sheila AnnieORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference45 articles.

1. US Food and Drug Administration. Guidance for industry: in vitro drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions. 2020. Available from: https://www.fda.gov/media/134582/download. [Accessed 30 Mar 2022].

2. US Food and Drug Administration. Guidance for industry: clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions. 2020. Available from: https://www.fda.gov/media/134581/download. [Accessed 30 Mar 2022].

3. European Medicines Agency. Guideline on the investigation of drug interactions. 2012. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions-revision-1_en.pdf. [Accessed 30 Mar 2022].

4. Fahmi OA, Maurer TS, Kish M, Cardenas E, Boldt S, Nettleton D. A combined model for predicting CYP3A4 clinical net drug-drug interaction based on CYP3A4 inhibition, inactivation, and induction determined in vitro. Drug Metab Dispos. 2008;36(8):1698–708.

5. Peters SA, Dolgos H. Requirements to establishing confidence in physiologically based pharmacokinetic (PBPK) models and overcoming some of the challenges to meeting them. Clin Pharmacokinet. 2019;58(11):1355–71.

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