Risk of Enzyme- and Transporter-mediated Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2022: A Detailed Analysis of In Vitro and Clinical Data Available in New Drug Application Reviews

Author:

Yu Jingjing,Wang Yan,Ragueneau-Majlessi Isabelle

Publisher

Elsevier BV

Reference24 articles.

1. ICH Guideline M12 on drug interaction studies 2022. Available online: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-m12-drug-interaction-studies-step-2b_en.pdf (Accessed September 18, 2023).

2. FDA Guidance for Industry: In vitro drug interaction studies - Cytochrom P450 enzyme- and transporter-mediated drug interactions 2020. Available online: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/in-vitro-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter-mediated-drug-interactions (Accessed September 18, 2023).

3. FDA Guidance for Industry: Clinical drug interaction studies - Cytochrom P450 enzyme- and transporter-mediated drug interactions. 2020. Available online: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter-mediated-drug-interactions (Accessed September 18, 2023).

4. EMA's Guideline on the Investigation of Drug Interactions 2012. Available online: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions_en.pdf (Accessed September 18, 2019).

5. MHLW's Guideline on Drug Interaction for Drug Development and Appropriate Provision of Information (8 Feb 2019). Available online: https://www.mhlw.go.jp/web/t_doc?dataId=00tc3525&dataType=1 (Accessed September 18, 2019).

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