Results 41 to 50 of about 6,306 (210)

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

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 pharmacokinetics and pharmacodynamics of canagliflozin in paediatric patients with type 2 diabetes mellitus

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Canagliflozin was recently approved in type 2 diabetes mellitus (T2DM) patients ≥10 and <18 years old as a single agent dosed once daily (QD) or in a fixed‐dose combination with metformin dosed twice daily (BID). We characterize canagliflozin pharmacokinetics in paediatric patients with T2DM, compare estimated individual and simulated ...
Nele Goeyvaerts, Per Olsson Gisleskog, Martine Neyens, Juan José Perez Ruixo, Saberi Rana Ali, Iolanda Cirillo, Oliver Ackaert   +6 more
wiley   +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

N‐acetylcysteine for non‐paracetamol‐induced acute liver failure in children: A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Non‐surgical treatment of acute liver failure (ALF) is primarily supportive and depends on the underlying cause. While N‐acetylcysteine (NAC) is proven effective in paracetamol‐induced ALF, its potential benefits in non‐paracetamol ALF for paediatric patients remain unclear.
Alise D. E. de Groot, Désanka M. Stoppels, Arno R. Bourgonje, Willemien F. J. Hof, Martin C. J. Kneyber, Daan J. Touw, Henkjan J. Verkade, Paola Mian   +7 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

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 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

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

Pharmacometric evaluation of pre‐referral rectal artesunate in children with severe malaria

British Journal of Clinical Pharmacology, EarlyView.
Aims Parenteral artesunate is the preferred first‐line treatment for severe malaria. Pre‐referral rectal artesunate suppositories are recommended where parenteral treatment is inaccessible. In this study, we compared dihydroartemisinin exposure and model‐predicted early parasite clearance following rectal artesunate and intravenous artesunate in ...
Ayorinde Adehin, Marie A. Onyamboko, Caterina Fanello, Nicholas J. White, Nicholas P. J. Day, Richard M. Hoglund, Joel Tarning   +6 more
wiley   +1 more source