Consistency of drug–drug and gene–drug interaction information in US FDA-approved drug labels

2013 ◽  
Vol 14 (2) ◽  
pp. 215-223 ◽  
Author(s):  
Daniela J Conrado ◽  
Hobart L Rogers ◽  
Issam Zineh ◽  
Michael A Pacanowski
Keyword(s):  
Drug Interaction ◽  
Interaction Information ◽  
Us Fda

Deficiencies in drug interaction information

2007 ◽  
Vol 186 (9) ◽  
pp. 483-483 ◽  
Author(s):  
Michelle Sweidan ◽  
James F Reeve
Keyword(s):  
Drug Interaction ◽  
Interaction Information

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

2020 ◽  
Vol 21 (6) ◽  
pp. 403-426 ◽  
Author(s):  
Sirimas Sudsakorn ◽  
Praveen Bahadduri ◽  
Jennifer Fretland ◽  
Chuang Lu
Keyword(s):  
Cytochrome P450 ◽  
Drug Interaction ◽  
Drug Interactions ◽  
Action Plan ◽  
European Medicines Agency ◽  
Cytochrome P450 Enzyme ◽  
Interaction Studies ◽  
P450 Enzyme ◽  
Us Fda

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 the 2017 draft in vitro and clinical DDI guidance. Methods: This study is aimed to provide an analysis of the updates along with a comparison of the DDI guidelines published by the European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) along with the current literature. Results: The updates were provided in the final FDA DDI guidelines and explained the rationale of those changes based on the understanding from research and literature. Furthermore, a comparison among the FDA, EMA, and PMDA DDI guidelines are presented in Tables 1, 2 and 3. Conclusion: The new 2020 clinical DDI guidance from the FDA now has even higher harmonization with the guidance (or guidelines) from the EMA and PMDA. A comparison of DDI guidance 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.

scholarly journals Toward a complete dataset of drug–drug interaction information from publicly available sources

2015 ◽  
Vol 55 ◽  
pp. 206-217 ◽  
Author(s):  
Serkan Ayvaz ◽  
John Horn ◽  
Oktie Hassanzadeh ◽  
Qian Zhu ◽  
Johann Stan ◽  
...  
Keyword(s):  
Drug Interaction ◽  
Interaction Information ◽  
Complete Dataset ◽  
Drug Drug Interaction
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