A regulatory viewpoint on transporter-based drug interactions

L Zhang, Y Zhang, JM Strong, KS Reynolds… - Xenobiotica, 2008 - Taylor & Francis
… provides a regulatory viewpoint on transporters and their potential role in drugdrug interactions.
It … This commentary therefore provides a regulatory viewpoint on transporters and their …

[HTML][HTML] A regulatory science viewpoint on botanical–drug interactions

M Grimstein, SM Huang - journal of food and drug analysis, 2018 - Elsevier
… scientific literature evaluating the interaction potential of … drug interaction liability is presented.
This review also highlights the regulatory science viewpoint on botanical–drug interactions

Drug-Drug interactions: scientific and regulatory perspectives

JT August, F Murad, MW Anders, JT Coyle, A Li - 1997 - books.google.com
… for drug-drug interactions. The chapters in this book present a comprehensive review of the
scientific and regulatory aspects of drug-drug interactions … The topics covered include drug

Predicting drugdrug interactions: an FDA perspective

L Zhang, Y Zhang, P Zhao, SM Huang - The AAPS journal, 2009 - Springer
… to guide further in vivo drug interaction studies and to … drug interaction potential during
drug development and uses a case study to highlight the impact of in vitro information on drug

Evaluation of cytochrome P450-mediated drugdrug interactions based on the strategies recommended by regulatory authorities

Y Kosugi, H Hirabayashi, T Igari, Y Fujioka, Y Hara… - Xenobiotica, 2012 - Taylor & Francis
… intestinal DDIs; however, EMEA regulation suggests that the assessment of intestinal DDIs
for CYP3A inhibitors should be performed if the drug is orally administered. No report has …

Scientific and regulatory perspectives on metabolizing enzyme− transporter interplay and its role in drug interactions: challenges in predicting drug interactions

L Zhang, Y Zhang, SM Huang - Molecular pharmaceutics, 2009 - ACS Publications
… predicting drug interactions based on in vitro evaluations, unexpected drugdrug interactions
do … Collectively, these interactions may be defined as “complex drug interactions” including …

The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective

TD Bjornsson, JT Callaghan, HJ Einolf, V Fischer… - Drug metabolism and …, 2003 - ASPET
… in vitro and in vivo pharmacokinetic drug-drug interaction studies targeted to development (…
by regulatory agencies in compound registration dossiers. Drug-drug interactions can lead to …

[HTML][HTML] Clinical decision support and new regulatory frameworks for medical devices: are we ready for it?-A viewpoint paper

S Van Laere, KM Muylle, P Cornu - International Journal of Health …, 2022 - ncbi.nlm.nih.gov
regulation is larger in scope compared to the United States. Returning to the example of CDS
for drug-drug interactions… the United States and stringent regulation in Europe can lead to …

2020 FDA drug-drug interaction guidance: a comparison analysis and action plan by pharmaceutical industrial scientists

S Sudsakorn, P Bahadduri, J Fretland… - Current drug …, 2020 - ingentaconnect.com
Drug-drug interactions (DDI) are key aspects of drug metabolism and pharmacokinetic
considerations and are studied in both preclinical development and throughout the clinical …

Clinical-pharmacological strategies to assess drug interaction potential during drug development

J Kuhlmann, W Mück - Drug safety, 2001 - Springer
Drug interactions in patients receiving multiple drug regimens … of new drugs and their
concomitant use with other drugs, there … viewpoint, considering different drug treatments in a drug