Assessment of the Quality and Quantity of Drug‐Drug Interaction Studies in Recent NDA Submissions: Study Design and Data Analysis Issues
- 1 October 1999
- journal article
- Published by Wiley in The Journal of Clinical Pharmacology
- Vol. 39 (10), 1006-1014
- https://doi.org/10.1177/00912709922011764
Abstract
This report investigates the quality and quantity of drug-drug interaction studies in recent new drug applications (NDAs). Eighty-nine studies contained in 14 NDAs submitted between December 1995 and...Keywords
This publication has 22 references indexed in Scilit:
- Nevirapine induces both CYP3A4 and CYP2B6 metabolic pathwaysClinical Pharmacology & Therapeutics, 1999
- Grapefruit juice (GFJ) has a small effect on lovastatin plasma HMG-CoA reductase inhibitor (HMGRI) profilesClinical Pharmacology & Therapeutics, 1999
- Mibefradil is a potent inhibitor of both CYP3A and P-glycoprotein (P-gp)Clinical Pharmacology & Therapeutics, 1999
- Life-Threatening Interaction of Mibefradil and β-Blockers With Dihydropyridine Calcium Channel BlockersJAMA, 1998
- What lessons can be learnt from withdrawal of mibefradil from the market?The Lancet, 1998
- Two New Warnings Added to Labeling for MibefradilPublished by American Medical Association (AMA) ,1998
- Antiretroviral Therapy for HIV Infection in 1997JAMA, 1997
- Lack of interaction between meloxicam and warfarin in healthy volunteersEuropean Journal of Clinical Pharmacology, 1997
- Incidence of Adverse Drug Events and Potential Adverse Drug EventsJAMA, 1995
- Terfenadine-Ketoconazole InteractionJAMA, 1993