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

…, HJ Einolf, V Fischer, L Gan, S Grimm, J Kao… - Drug metabolism and …, 2003 - ASPET
Current regulatory guidances do not address specific study designs for in vitro and in vivo
drug-drug interaction studies. There is a common desire by regulatory authorities and by …

The conduct of in vitro and in vivo drug‐drug interaction studies: a PhRMA perspective

TD Bjornsson, JT Callaghan, HJ Einolf… - The Journal of …, 2003 - Wiley Online Library
Current regulatory guidances do not address specific study designs for in vitro and in vivo
drug‐drug interaction studies. There is a common desire by regulatory authorities and by …

The conduct of in vitro studies to address time-dependent inhibition of drug-metabolizing enzymes: a perspective of the pharmaceutical research and manufacturers of …

SW Grimm, HJ Einolf, SD Hall, K He, HK Lim… - Drug Metabolism and …, 2009 - ASPET
Time-dependent inhibition (TDI) of cytochrome P450 (P450) enzymes caused by new molecular
entities (NMEs) is of concern because such compounds can be responsible for clinically …

Physiologically based pharmacokinetic model qualification and reporting procedures for regulatory submissions: a consortium perspective

…, GL Dickinson, N Djebli, HJ Einolf… - Clinical …, 2018 - Wiley Online Library
This work provides a perspective on the qualification and verification of physiologically based
pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on …

In vitro and in vivo induction of cytochrome p450: a survey of the current practices and recommendations: a pharmaceutical research and manufacturers of america …

V Chu, HJ Einolf, R Evers, G Kumar, D Moore… - Drug Metabolism and …, 2009 - ASPET
Cytochrome P450 (P450) induction is one of the factors that can affect the pharmacokinetics
of a drug molecule upon multiple dosing, and it can result in pharmacokinetic drug-drug …

[HTML][HTML] Fidelity of nucleotide insertion at 8-oxo-7, 8-dihydroguanine by mammalian DNA polymerase δ: steady-state and pre-steady-state kinetic analysis

HJ Einolf, FP Guengerich - Journal of Biological Chemistry, 2001 - ASBMB
Nucleotide insertion opposite 8-oxo-7,8-dihydroguanine (8-oxoG) by fetal calf thymus DNA
polymerase δ (pol δ) was examined by steady-state and pre-steady-state rapid quench …

Evaluation of a new molecular entity as a victim of metabolic drug-drug interactions—an industry perspective

…, Y Chen, C Lu, G Lai, L Leung, S Tse, HJ Einolf… - Drug Metabolism and …, 2016 - ASPET
Under the guidance of the International Consortium for Innovation and Quality in Pharmaceutical
Development (IQ), scientists from 20 pharmaceutical companies formed a Victim Drug-…

Steady-state and pre-steady-state kinetic analysis of 8-oxo-7, 8-dihydroguanosine triphosphate incorporation and extension by replicative and repair DNA …

HJ Einolf, N Schnetz-Boutaud, FP Guengerich - Biochemistry, 1998 - ACS Publications
The kinetics of 8-oxo-7,8-dihydroguanosine triphosphate (8-oxo-dGTP) incorporation into
DNA by Escherichia coli polymerases I exo - (KF - ) and II exo - (Pol II - ), HIV-1 RT reverse …

Considerations from the innovation and quality induction working group in response to drug-drug interaction guidances from regulatory agencies: focus on CYP3A4 …

…, S Dallas, C Fung, M Mohutsky, HJ Einolf… - Drug Metabolism and …, 2018 - ASPET
The Innovation and Quality Induction Working Group presents an assessment of best practice
for data interpretation of in vitro induction, specifically, response thresholds, variability, …

Cytochrome P450 1A2 detoxicates aristolochic acid in the mouse

TA Rosenquist, HJ Einolf, KG Dickman, L Wang… - Drug metabolism and …, 2010 - ASPET
Aristolochic acids (AAs) are plant-derived nephrotoxins and carcinogens responsible for
chronic renal failure and associated urothelial cell cancers in several clinical syndromes known …