The cytochrome P450 isoenzyme and some new opportunities for the prediction of negative drug interaction in vivo

DA Sychev, GM Ashraf, AA Svistunov… - Drug design …, 2018 - Taylor & Francis
Cytochrome (CYP) 450 isoenzymes are the basic enzymes involved in Phase I
biotransformation. The most important role in biotransformation belongs to CYP3A4 …

Advancing precision medicine: A review of innovative In Silico approaches for drug development, clinical pharmacology and personalized healthcare

L Marques, B Costa, M Pereira, A Silva, J Santos… - Pharmaceutics, 2024 - mdpi.com
The landscape of medical treatments is undergoing a transformative shift. Precision
medicine has ushered in a revolutionary era in healthcare by individualizing diagnostics and …

Identification of endogenous biomarkers to predict the propensity of drug candidates to cause hepatic or renal transporter-mediated drug-drug interactions

X Chu, GH Chan, R Evers - Journal of pharmaceutical sciences, 2017 - Elsevier
Drug transporters expressed in liver and kidney play a critical role in the elimination of a
wide range of drugs and xenobiotics and inhibition of these transporters may therefore …

Current practices, gap analysis, and proposed workflows for PBPK modeling of cytochrome P450 induction: an industry perspective

N Hariparsad, D Ramsden, K Taskar… - Clinical …, 2022 - Wiley Online Library
The International Consortium for Innovation and Quality (IQ) Physiologically Based
Pharmacokinetic (PBPK) Modeling Induction Working Group (IWG) conducted a survey …

Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part II. A mechanistic PBPK model for IR formulation comparison, proton pump inhibitor drug …

XJH Pepin, AJ Moir, JC Mann, NJ Sanderson… - European journal of …, 2019 - Elsevier
Abstract Acalabrutinib (Calquence®) 100 mg (bid) has received accelerated approval by
FDA for the treatment of adult patients with mantle cell lymphoma (MCL) who have received …

PBPK modeling to predict drug‐drug interactions of ivosidenib as a perpetrator in cancer patients and qualification of the Simcyp platform for CYP3A4 induction

J Bolleddula, A Ke, H Yang… - CPT: pharmacometrics & …, 2021 - Wiley Online Library
Ivosidenib is a potent, targeted, orally active, small‐molecule inhibitor of mutant isocitrate
dehydrogenase 1 (IDH1) that has been approved in the United States for the treatment of …

Bayesian population physiologically-based pharmacokinetic (PBPK) approach for a physiologically realistic characterization of interindividual variability in clinically …

M Krauss, K Tappe, A Schuppert, L Kuepfer, L Goerlitz - PloS one, 2015 - journals.plos.org
Interindividual variability in anatomical and physiological properties results in significant
differences in drug pharmacokinetics. The consideration of such pharmacokinetic variability …

Perspective: 4 β-hydroxycholesterol as an emerging endogenous biomarker of hepatic CYP3A

J Mao, I Martin, J McLeod, G Nolan… - Drug metabolism …, 2017 - Taylor & Francis
A key goal in the clinical development of a new molecular entity is to quickly identify whether
it has the potential for drug–drug interactions. In particular, confirmation of in vitro data in the …

Managing the risk of CYP3A induction in drug development: a strategic approach

BC Jones, H Rollison, S Johansson… - Drug Metabolism and …, 2017 - ASPET
Induction of cytochrome P450 (P450) can impact the efficacy and safety of drug molecules
upon multiple dosing with coadministered drugs. This strategy is focused on CYP3A since …

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 – LCMS: small molecules, peptides and small molecule …

J Welink, E Yang, N Hughes, B Rago, E Woolf… - Bioanalysis, 2017 - Taylor & Francis
The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los
Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of …