Results 81 to 90 of about 12,660 (249)

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

Exploring inter-ethnic and inter-patient variability and optimal dosing of osimertinib: a physiologically based pharmacokinetic modeling approach

Frontiers in Pharmacology
Purpose: This study aimed to develop and validate a physiologically based pharmacokinetic (PBPK) model for osimertinib (OSI) to predict plasma trough concentration (Ctrough) and pulmonary EGFRm+ (T790M and L858R mutants) inhibition in Caucasian, Japanese,
Feng Liang, Yimei Zhang, Qian Xue, Na Yao   +3 more
doaj   +1 more source

PrEP at the site of action in cisgender and transgender women: A pharmacology study of blood and rectal CD4+ lymphocytes

British Journal of Clinical Pharmacology, EarlyView.
Background Female sex hormones used in feminizing hormone therapy (FHT) may influence activation and persistence of HIV pre‐exposure prophylaxis (PrEP) medications. The clinical relevance of this interaction remains unclear, particularly for transgender and cisgender women (TGW and CGW).
Elizabeth Hastie, Megha Srivasta, Edward R. Cachay, Leah Burke, Sara Gianella, Stephen Rawlings, Frank Z. Stanczyk, Craig Sykes, Angela D. M. Kashuba, Jill Blumenthal, Mackenzie L. Cottrell   +10 more
wiley   +1 more source

PBPK Modeling of Lamotrigine and Efavirenz during Pregnancy: Implications for Personalized Dosing and Drug-Drug Interaction Management

Pharmaceutics
This study aimed to model the pharmacokinetics of lamotrigine (LTG) and efavirenz (EFV) in pregnant women using physiologically based pharmacokinetic (PBPK) and pregnancy-specific PBPK (p-PBPK) models.
Bárbara Costa, Maria João Gouveia, Nuno Vale   +2 more
doaj   +1 more source

Advances in Human Mass Balance Studies: An IQ Consortium Perspective on Current Practices and Emerging Trends

Clinical Pharmacology &Therapeutics, EarlyView.
Human radiolabeled mass balance studies are crucial for comprehensively characterizing the absorption, distribution, metabolism, and excretion (ADME) of investigational drugs, providing essential data for drug development, regulatory evaluation, and product labeling.
Jason Boer, Ellen Cannady, Filip Cuyckens, Ulrike Glaenzel, Camille Granvil, Felix Huth, Alexander D. James, Wenying Li, Céline Veau, Graeme Young, Qin Yue, Gregory S. Walker, Upendra A. Argikar, Jonathan N. Bauman, Cathy Cantalloube, Yu‐Luan Chen, Ping Kang, Patricia Moliner, Mette L. Pedersen, Isabel Piel, Simone Schadt, Hanno Schieferstein, Julia Suchomel, Shuai Wang, S. Cyrus Khojasteh   +24 more
wiley   +1 more source

Quantitative global sensitivity analysis of a biologically based dose-response pregnancy model for the thyroid endocrine system [PDF]

, 2015
A deterministic biologically based dose-response model for the thyroidal system in a near-term pregnant woman and the fetus was recently developed to evaluate quantitatively thyroid hormone perturbations.
Annie Lumen, George D. Loizou, Jeffrey W. Fisher, Kevin McNally, Nysia George   +4 more
core   +2 more sources

Making PBPK models more reproducible in practice

Briefings in Bioinformatics
Abstract Systems biology aims to understand living organisms through mathematically modeling their behaviors at different organizational levels, ranging from molecules to populations. Modeling involves several steps, from determining the model purpose to developing the mathematical model, implementing it computationally, simulating the ...
Elena Domínguez-Romero, Stanislav Mazurenko, Martin Scheringer, Vítor A P Martins dos Santos, Chris T Evelo, Mihail Anton, John M Hancock, Anže Županič, Maria Suarez-Diez   +8 more
openaire   +3 more sources

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

Is a Clinical Trial With a Non‐Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK

Clinical Pharmacology &Therapeutics, EarlyView.
Although physiologically based pharmacokinetic (PBPK) modeling is increasingly being used to support oral drug formulation bridging, the acceptance by regulatory agencies is low. One of the primary concerns is the absence of clinical pharmacokinetic (PK) data from a non‐bioequivalent (non‐BE) batch during model validation.
Jin Dong, Andrea Moir, Xavier Pepin, Elizabeth Lowe, Sandy Hopkins, Weifeng Tang, Diansong Zhou   +6 more
wiley   +1 more source

A White Paper on Advancing Long‐Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation

Clinical Pharmacology &Therapeutics, EarlyView.
As use cases for long‐acting therapeutics expand across clinical indications, there is a critical need to ensure the inclusion of women who are pregnant or breastfeeding, infants and children—populations with a historical gap in the availability of interventions already approved for use in adults.
Moherndran Archary, Robert Bies, Osei Boateng, Rachel Daley, Pierre Gashema, Mili Karina, Emily Njuguna, Sharon Nachman, Nathaniel Nkrumah, Carolyne Odula, Andrew Owen, Ethel D. Weld, Prajith Venkatasubramanian, Adeniyi Olagunju, on behalf of the Community of Practice for Long‐acting Therapeutics for Maternal and Paediatric Health, Rana Abutaima, Dorothy Akongo, Abdulnaser Alsharaa, Moherndran Archary, Shakir Atoyebi, Benoit Bestgen, Robert Bies, Osei Boateng, Andrew Butler, Edmund Capparelli, Rachel Daley, Layla Davies, Joelle Dountio, Henry Enzama, Pierre Gashema, Katila George, Dan Hawcutt, Rene Holm, Patrick Gad Iradukunda, Elodie Jambert, Mili Karina, Linda Lewis, Grace Miheso, Sebastien Morin, Andrew Morrison, Sharon Nachman, Shadia Nakalema, Emily Njunga, Nathaniel Nkrumah, Carolyne Odula‐Obonyo, Brenda Okware, Adeniyi Olagunju, Andrew Owen, Martina Penazzato, Natella Rakhmanina, Mphako Brighton Ratlabyana, Rachel Scott, Kimberly Struble, Andre‐Marie Tchouatieu, Catherine Unsworth, Prajith Venkatasubramanian, Catriona Waitt, Ethel Weld, Janine Winterbottom, Leena Zino   +59 more
wiley   +1 more source