Results 111 to 120 of about 11,033 (240)

Effects of Renal and Hepatic Impairment on the Pharmacokinetics of Zilurgisertib

British Journal of Clinical Pharmacology, Volume 92, Issue 5, Page 1339-1351, May 2026.
Aim Small‐molecule activin receptor‐like kinase‐2 inhibitor zilurgisertib (INCB000928) is under investigation in a pivotal trial for the treatment of fibrodysplasia ossificans progressiva (FOP), an ultrarare genetic condition. This analysis assessed effects of renal and hepatic impairment on zilurgisertib pharmacokinetics.
Yan‐ou Yang, Yunlan Fang, Phillip Wang, Xiang Liu, Jay Getsy, Kevin Rockich   +5 more
wiley   +1 more source

A Phase 1, Open‐Label, Single‐Dose Study of the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib, an FGFR Inhibitor

Clinical Pharmacology in Drug Development, Volume 15, Issue 5, May 2026.
Abstract Erdafitinib, an oral pan‐FGFR inhibitor is extensively metabolized in the liver. This open‐label, single‐dose, phase 1 study evaluated the pharmacokinetics (PK) of erdafitinib in participants with hepatic impairment versus healthy controls. Overall, 26 participants were enrolled.
Wei Zhu, Peter Hellemans, Anna Mitselos, Marc De Meulder, Juhui James Jiao, Hui Tian   +5 more
wiley   +1 more source

Covariate modeling in pharmacometrics: General points for consideration

CPT: Pharmacometrics & Systems Pharmacology
Modeling the relationships between covariates and pharmacometric model parameters is a central feature of pharmacometric analyses. The information obtained from covariate modeling may be used for dose selection, dose individualization, or the planning of
Kinjal Sanghavi, Jakob Ribbing, James A. Rogers, Mariam A. Ahmed, Mats O. Karlsson, Nick Holford, Estelle Chasseloup, Malidi Ahamadi, Kenneth G. Kowalski, Susan Cole, Essam Kerwash, Janet R. Wade, Chao Liu, Yaning Wang, Mirjam N. Trame, Hao Zhu, Justin J. Wilkins, for the ISoP Standards & Best Practices Committee   +17 more
doaj   +1 more source

Capability Development in the European Medicines Regulatory Network—A European Learning Needs Analysis and Survey Study

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1288-1297, May 2026.
The European Medicines Regulatory Network plays a critical role in safeguarding public health through the assessment and supervision of human medicines. However, rapid scientific and technological advancements have exposed capability deficits across the network, threatening timely and effective regulatory decision‐making.
Naomi Beard, Marko J. Kallio, Luca Kosec, Ulrika Espefält Westin, on behalf of the IncreaseNET consortium   +4 more
wiley   +1 more source

A Combined Modeling Approach to Predict the Effect of Gastric Emptying Delay on the Pharmacokinetics of Small Molecules

CPT: Pharmacometrics & Systems Pharmacology
Dulaglutide, a long‐acting glucagon‐like peptide‐1 (GLP‐1) receptor agonist, is approved for improving glycemic control and reducing cardiovascular risks in patients with type 2 diabetes mellitus (T2DM).
Maria M. Posada, Karen B. Schneck, Bridget L. Morse, Luc R. A. Rougee, Lai San Tham, Jessica F. Rehmel, Brian Thompson, Stephen D. Stamatis, Stephen D. Hall, Gemma L. Dickinson   +9 more
doaj   +1 more source

Cardiovascular‐Kidney‐Metabolic Syndrome in People With HIV: An Emerging Frontier for Clinical Pharmacology

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1136-1140, May 2026.
As antiretroviral therapy (ART) prolongs lifespans, people with HIV (PWH) face a new syndemic: Cardiovascular‐Kidney‐Metabolic (CKM) syndrome. Yet CKM in PWH is poorly characterized. Inflammation, complex pharmacokinetic (PK) alterations, ART‐associated metabolic effects, and gut dysbiosis amplify risk. Managing CKM increases medication burden, thereby
Aaron S. Devanathan, Thomas D. Nolin
wiley   +1 more source

PKRxiv: A Best Practice Model for Advancing Pharmacoequity Through Open Pharmacokinetic Data Sharing

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1235-1248, May 2026.
Model‐informed drug development is increasingly integrated across the drug development continuum, enabling more efficient, cost‐effective, and targeted trials while reducing reliance on animal studies. Achieving pharmacoequity requires not only equitable access to medicines but also to the data and knowledge that inform drug development and regulatory ...
Shakir Atoyebi, Prajith Venkatasubramanian, Abdulafeez Akinloye, Oluwasegun Eniayewu, Brookie M. Best, Laura Else, Adeniyi Olagunju   +6 more
wiley   +1 more source

The implications of model-informed drug discovery and development for tuberculosis [PDF]

, 2016
Despite promising advances in the field and highly effective first-line treatment, an estimated 9.6 million people are still infected with tuberculosis (TB).
Davies, GR, Della Pasqua, O, Gillespie, SH, Muliaditan, M, Simonsson, USH   +4 more
core  

Advancing Maternal Health with Long‐Acting Therapeutics: Priorities, Efficacy and Safety Considerations, and Emerging Technologies

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1179-1194, May 2026.
Maternal health remains a critical global concern, particularly in underserved populations and in low‐ and middle‐income countries where access to safe and effective therapeutics is limited. Despite the use of medications by most women during pregnancy, the exclusion of pregnant and lactating women from clinical trials has resulted in significant data ...
Rachel K. Scott, Sharon Nachman, Ethel D. Weld, Rachel Daley, Shakir Atoyebi, Robert Bies, Catriona Waitt, Adeniyi Olagunju   +7 more
wiley   +1 more source

Advancing Pharmacoequity Globally: Reflections from the ASCPT Development, Regulatory, and Outcomes Network

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1156-1159, May 2026.
ASCPT has a mission to advance clinical pharmacology and translational sciences to reduce health disparities. The development, regulatory, and outcomes (DRO) network within ASCPT strives to advance pharmacoequity globally. Pharmacoequity, coined by Utibe Essien (2021), is the principle that all individuals, regardless of race, ethnicity, geography, or ...
Priya Jayachandran, Mayur K. Ladumor, Georgios Vlasakakis, Andrew Riselli, Katarina V. Ilic, Rob C. van Wijk, Mohamed Elmeliegy, Jatinder Kaur Mukker, Aarti Sawant‐Basak, Tao Long, Juyao Dong, Noha Rayad, Tao Zhang, on behalf of the DRO Network   +13 more
wiley   +1 more source