Clinical studies on drug–drug interactions involving metabolism and transport: methodology, pitfalls, and interpretation

A Tornio, AM Filppula, M Niemi… - Clinical Pharmacology …, 2019 - Wiley Online Library
Many drug–drug interactions (DDI s) are based on alterations of the plasma concentrations
of a victim drug due to another drug causing inhibition and/or induction of the metabolism or …

Therapeutic protein drug interactions: a white paper from the international consortium for innovation and quality in pharmaceutical development

DE Coutant, DW Boulton, UP Dahal… - Clinical …, 2023 - Wiley Online Library
Typically, therapeutic proteins (TPs) have a low risk for eliciting meaningful drug interactions
(DIs). However, there are select instances where TP drug interactions (TP‐DIs) of clinical …

Pediatric drug‐drug interaction evaluation: drug, patient population, and methodological considerations

D Gonzalez, J Sinha - The Journal of Clinical Pharmacology, 2021 - Wiley Online Library
Hospitalized pediatric patients and those with complex or chronic conditions treated on an
outpatient basis are commonly prescribed multiple drugs, resulting in increased risk for drug …

An Investigation in the Comparability of the Exposure and Recommended Dose of Selected Pfizer Drugs in East Asian Countries: Is Mutual Usage of Clinical Data …

DD Wang, Y Yu, K Fukuhara, Y Liu… - The Journal of …, 2024 - Wiley Online Library
The current regulatory path for new drug registration in East Asian countries has led to
significant delay of the new medicines in these countries. A unified regulatory path and …

Analysis of US Food and Drug Administration oncology approvals on the characterization of hepatic impairment effect and dosing recommendations

DZ Yang, A Alhadab, K Parivar… - Clinical …, 2022 - Wiley Online Library
Patients with cancer and advanced hepatic impairment (HI)(ie, moderate and severe
impairment) are often excluded from first‐in‐patient, phase II, and phase III studies. Thus …

Matrix Effects of the Hydroethanolic Extract of Calyces of Physalis peruviana L. on Rutin Pharmacokinetics in Wistar Rats Using Population Modeling

GP Domínguez Moré, MI Cardona, PM Sepúlveda… - pharmaceutics, 2021 - mdpi.com
Rutin is the rutinose conjugate of quercetin. It presents several biological activities and is the
major flavonoid in the hydroalcoholic extract of the calyces of Physalis peruviana L. It also …

Successful prediction of human pharmacokinetics after oral administration by optimized physiologically based pharmacokinetics approach and permeation assay …

K Mayumi, T Akazawa, T Kanazu, S Ohnishi… - Journal of …, 2020 - Elsevier
None of the physiologically based pharmacokinetic (PBPK) approaches using preclinical
data show high predictability of human pharmacokinetic (PK) profiles for drugs affected by …

계량약리학을활용한타크로리무스와미코페놀레이트모페틸의약물상호작용평가

김재현 - 2018 - s-space.snu.ac.kr
P< 0.05), MPA 와 대사체의 약동력학 파라미터는 유의미한 변화를 보이지 않았다. TAC 의
청소율은 MMF 와 병용하지 않았을 때에는 17.8 L/h (상대표준오차 11%) 였고, MMF 와 …