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2020 FDA Drug-Drug Interaction Guidance: A Comparison Analysis and Action Plan by Pharmaceutical Industrial Scientists

Author(s):

Sirimas Sudsakorn, Praveen Bahadduri, Jennifer Fretland and Chuang Lu*   Pages 1 - 25 ( 25 )

Abstract:


Background: In January 2020, the US FDA published two final guidelines, one entitled “In vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry” and the other entitled “Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry”. These were updated from 2017 draft in vitro and clinical DDI guidances.

Methods: This commentary is aimed to provide an analysis of the updates along with a comparison of the DDI guidelines published by European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) along with the current literature.

Results: We provided the updates in the final FDA DDI guidelines and explained the rational of those changes based on our understanding from our own research and literature. Further, a comparison among the FDA, EMA, and PMDA DDI guidelines were presented in Tables 1,2, and 3. Conclusion: The new 2020 clinical DDI guidance from the FDA now has even higher harmonization with the guidances (or guidelines) from the EMA and PMDA. A comparison of DDI guidances from the FDA 2017, 2020, EMA, and PMDA on CYP and transporter based DDI, mathematical models, PBPK and clinical evaluation of DDI is presented in this review.

Keywords:

Cytochrome P450, CYP, transporter, DDI, PK interaction, clinical DDI risk, PBPK, in vitro assay.

Affiliation:

Department of Drug metabolism and pharmacokinetics, Sanofi company, Waltham, Department of Drug metabolism and pharmacokinetics, Sanofi company, Waltham, Department of Drug metabolism and pharmacokinetics, Sanofi company, Waltham, Department of Drug metabolism and pharmacokinetics, Sanofi company, Waltham



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