Results 41 to 50 of about 6,245 (194)

The Many Flavors of Model‐Based Meta‐Analysis: Part I—Introduction and Landmark Data

CPT: Pharmacometrics & Systems Pharmacology, 2016
Meta‐analysis is an increasingly important aspect of drug development as companies look to benchmark their own compounds with the competition. There is scope to carry out a wide range of analyses addressing key research questions from preclinical through
M Boucher, M Bennetts
doaj   +1 more source

The status of pharmacometrics in pregnancy: highlights from the 3^rd American conference on pharmacometrics [PDF]

British Journal of Clinical Pharmacology, 2012
Physiological changes during pregnancy may alter drug pharmacokinetics. Therefore, mechanistic understanding of these changes and, ultimately, clinical studies in pregnant women are necessary to determine if and how dosing regimens should be adjusted.
Hasselt, J.G.C. van, Andrew, M.A., Hebert, M.F., Tarning, J., Vicini, P., Mattison, D.R.   +5 more
openaire   +3 more sources

Physiologically‐based pharmacokinetic modelling of uridine 5′‐diphosphoglucorosultransferase (UGT) substrate drugs in pregnant women

British Journal of Clinical Pharmacology, EarlyView.
Aims While pregnancy‐related changes in phase I enzyme activity are well‐documented, less is known about the impact on phase II enzymes. This study aimed to test the hypothesis that changes in the pharmacokinetics (PK) of uridine 5′‐diphosphoglucuronosyltransferase (UGT) substrates during pregnancy result from altered enzyme expression or activity ...
William Saffaf, Ymke van der Velde, Paul R. V. Malik, Jelmer R. Prins, Sanne J. Gordijn, Daan J. Touw, Paola Mian   +6 more
wiley   +1 more source

A dose‐finding population pharmacokinetic/pharmacodynamic model of ginisortamab, an anti‐gremlin‐1 monoclonal antibody, in patients with solid tumours

British Journal of Clinical Pharmacology, EarlyView.
Aims Ginisortamab, a first‐in‐class human monoclonal antibody for the treatment of advanced solid tumours, binds to gremlin‐1 and restores bone morphogenetic protein signalling. We used pharmacokinetic/pharmacodynamic (PK/PD) modelling to characterize the relationship between ginisortamab dose and serum gremlin‐1 binding, using model‐based simulations ...
Yin Cheong Wong, Luisa Rojas Chavarro, Paul Jones, David Egging, Wanchana Ungphakorn, Marta Valle, Ivan Matthews   +6 more
wiley   +1 more source

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source

A perspective on the current use of the phase distribution model for predicting milk‐to‐plasma drug concentration ratio

CPT: Pharmacometrics & Systems Pharmacology, 2022
The phase distribution model, proposed by Atkinson and Begg in 1990, has been widely used for predicting breastmilk‐to‐plasma drug concentration ratio. However, misrepresentations of the equations have been noted in recent publications.
Mian Zhang, Caroline Sychterz, Ming Chang, Lu Huang, Brian J. Schmidt, Lu Gaohua   +5 more
doaj   +1 more source

The International Society of Pharmacometrics [PDF]

Journal of Pharmacokinetics and Pharmacodynamics, 2013
In 2011, the American Society of Pharmacometrics (ASoP) was founded and over 600 members worldwide joined ASoP within 6 months. In 2012, ASoP evolved to the International Society of Pharmacometrics (ISoP) to reflect the increasing number of international members.
Marc Pfister, Donald E. Mager, Nicholas H. G. Holford, Brian Corrigan, Stacey Tannenbaum, Rene Bruno, Liping Zhang, Yaning Wang, David Z. D’Argenio   +8 more
openaire   +1 more source

First‐in‐human, phase I, randomized, safety, pharmacokinetic, food‐effect and pharmacodynamic study of a tyrosine kinase 2/Janus kinase 1 inhibitor, SDC‐1801

British Journal of Clinical Pharmacology, EarlyView.
Aim The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), food‐effect (FE) and pharmacodynamics (PD) of an oral tyrosine kinase‐2 (TYK2)/Janus kinase‐1 (JAK1) inhibitor, SDC‐1801, in healthy adult participants. Methods This first‐in‐human study randomized 95 male and female participants.
Chris Brearley, Sam Francis, John Reader, Judi Proctor   +3 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

Development and Application of a Mechanistic Population Modeling Approach to Describe Abemaciclib Pharmacokinetics

CPT: Pharmacometrics & Systems Pharmacology, 2020
Abemaciclib is an oral anticancer drug that inhibits cyclin dependent kinases 4 and 6 and is metabolized by cytochrome P450 3A in the intestines and liver to active metabolites.
Emmanuel Chigutsa, Siva Rama Prasad Kambhampati, Amanda Karen Sykes, Maria M. Posada, Jan‐Stefan van derWalt, P. Kellie Turner   +5 more
doaj   +1 more source