Drugdrug interaction studies: regulatory guidance and an industry perspective

T Prueksaritanont, X Chu, C Gibson, D Cui, KL Yee… - The AAPS journal, 2013 - Springer
recommendations on a broad range of in vitro and in vivo studies to evaluate drugdrug
interaction (… This paper aims to provide an overview of these new recommendations and an in-…

[PDF][PDF] Drug interactions: scientific and clinical principles

M Gabay, SH Spencer - Am. Fam. Physician, 2019 - accp.com
… potential drug interactions. 4. Evaluate the strengths and weaknesses of available drug
interaction resources. … The authors recommended that clinicians check more than one 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
… However, EMEA recommends using unbound concentration for both the K i … Recommended
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Dosing recommendations for pharmacogenetic interactions related to drug metabolism

KK Filipski, MA Pacanowski… - Pharmacogenetics …, 2016 - journals.lww.com
… CYP2D6, genotype-based recommendations to consider therapeutic drug monitoring or
dose reduction are implicit on the basis of drug interaction recommendations). Otherwise, PGx …

Metabolism‐related pharmacokinetic drugdrug interactions with tyrosine kinase inhibitors: current understanding, challenges and recommendations

YL Teo, HK Ho, A Chan - British journal of clinical …, 2015 - Wiley Online Library
… evaluating patients for potential drug interactions during therapy 1. Drugdrug interactions
(DDIs) occur when a patient's pharmacological or clinical response to the drug is modified by …

… drug-drug interactions with drugs approved by the US Food and Drug Administration in 2020: mechanistic understanding and clinical recommendations

J Yu, Y Wang, I Ragueneau-Majlessi - Drug Metabolism and Disposition, 2022 - ASPET
… Applying the categorization recommended by the FDA, any drug interactions with area under
the time-plasma concentration curve (AUC) changes ≥5-fold (ie, AUCRs ≥5 or ≤0.2), 2- …

… Induction Working Group in response to drug-drug interaction guidance from regulatory agencies: guidelines on model fitting and recommendations on time course …

SG Wong, D Ramsden, S Dallas, C Fung… - Drug Metabolism and …, 2021 - ASPET
Regulatory agencies continue to update and evolve their guidance for the conduct of in vitro
… -mediated drug-drug interactions (DDIs). The final guidance released by the Food and Drug

Hepatic transporter‐mediated pharmacokinetic drugdrug interactions: Recent studies and regulatory recommendations

N Izat, S Sahin - Biopharmaceutics & Drug Disposition, 2021 - Wiley Online Library
… of drugs, and hence, drugdrug interactions. In parallel with the growing research interest in
this area, regulatory … hepatic transporter-mediated drugdrug interactions can be taken into …

Information needs for making clinical recommendations about potential drug-drug interactions: a synthesis of literature review and interviews

KM Romagnoli, SD Nelson, L Hines, P Empey… - BMC medical informatics …, 2017 - Springer
… Our broader goal – and the specific focus of this paper – is to develop information models
and tools that will provide drug-drug interaction experts with clear and usable views of …

Consensus recommendations for systematic evaluation of drugdrug interaction evidence for clinical decision support

RT Scheife, LE Hines, RD Boyce, SP Chung… - Drug safety, 2015 - Springer
recommendations for systematic evaluation of evidence for DDIs from the scientific literature,
drug product labeling, and regulatory … This paper describes recommendations by the …