Results 51 to 60 of about 6,010 (176)

Systematic review and scoring‐based selection of pharmacokinetic models for precision dosing of vancomycin in neonates and children

British Journal of Clinical Pharmacology, EarlyView.
This systematic review identified 112 population pharmacokinetic models of vancomycin in neonates and children. To support rational model selection for model‐informed precision, we developed and applied expert‐driven, transparent criteria that integrate both methodological rigour and clinical relevance.
Zoë Vander Elst, Pieter‐Jan Spiessens, Dorian Vanneste, Nada Dia, Matthias Gijsen, Isabel Spriet, Karel Allegaert, Erwin Dreesen, Anne Smits   +8 more
wiley   +1 more source

Population Pharmacokinetic and Pharmacokinetic/Pharmacodynamic Analyses of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria

Drugs in R&D
Background and Objective Paroxysmal nocturnal hemoglobinuria is a rare blood disorder characterized by life-threatening hemolysis and thrombosis. Complement C5 inhibitor therapy improves symptoms and life prognosis; however, it can result in insufficient
Ryan L. Crass, Brandon Smith, Sven Adriaens, Sunny Chapel, Grant Langdon   +4 more
doaj   +1 more source

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

Clinical Pharmacology &Therapeutics, EarlyView.
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

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

Clinical Pharmacology &Therapeutics, EarlyView.
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, EarlyView.
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

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

Clinical Pharmacology &Therapeutics, EarlyView.
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

Software Tools for Model-Informed Precision Dosing: How Well Do They Satisfy the Needs?

Frontiers in Pharmacology, 2020
Model-informed precision dosing (MIPD) software tools are used to optimize dosage regimens in individual patients, aiming to achieve drug exposure targets associated with desirable clinical outcomes.
Wannee Kantasiripitak, Ruth Van Daele, Ruth Van Daele, Matthias Gijsen, Matthias Gijsen, Marc Ferrante, Marc Ferrante, Isabel Spriet, Isabel Spriet, Erwin Dreesen, Erwin Dreesen   +10 more
doaj   +1 more source

Commentary on Pharmacometrics for Immunotherapy.

CPT: pharmacometrics & systems pharmacology, 2017
This commentary provides an overview of recent examples of pharmacometrics applied during the clinical development of two antagonists of the programmed death-1 (PD-1) cell surface receptor, pembrolizumab and nivolumab. Despite the remarkable achievements obtained in predicting the correct dosing schedule from different quantitative approaches, data ...
Garrido, MJ, Berraondo, P, Trocóniz, IF
openaire   +2 more sources

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

Clinical Pharmacology &Therapeutics, EarlyView.
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

Pharmacometrics models with hidden Markovian dynamics [PDF]

Journal of Pharmacokinetics and Pharmacodynamics, 2017
The aim of this paper is to provide an overview of pharmacometric models that involve some latent process with Markovian dynamics. Such models include hidden Markov models which may be useful for describing the dynamics of a disease state that jumps from one state to another at discrete times.
openaire   +3 more sources