Results 81 to 90 of about 14,687 (252)

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

Advancing Pharmacometrics in Africa: Insights and Perspectives From the 2025 Pharmacometrics Africa Conference. [PDF]

Clin Pharmacol Ther
Pharmacometrics (PMX) in Africa has transitioned from foundational capacity‐building to job creation, scientific leadership, regulatory influence, and health innovation. To accelerate this progress, the 2025 Pharmacometrics Africa Conference (PMXAC‐2025) convened key stakeholders to consolidate the continental PMX community, review progress in local ...
Adeagbo BA, Asiimwe IG, Chaba L, Kawuma AN, Ojara FW, Orherhe OM, Asiimwe SP, Pillay-Fuentes Lorente V, Sawe S, Phogole CM, Waitt C, Mouksassi S, Pillai GC.   +12 more
europepmc   +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

Repurposing Drugs for Malaria through a Human Dose Prediction: A Case Study with Berzosertib

Clinical Pharmacology &Therapeutics, EarlyView.
Repurposing drugs whose clinical safety has been established offers a valuable approach to reduce the cost and time associated with the development of new drugs for malaria. Here, we investigate the potential to repurpose the anticancer kinase inhibitor berzosertib for the treatment of malaria, by assessing whether a predicted efficacious human dose ...
Devasha Redhi, Mwila Mulubwa, Mmakwena M. Mmonwa, Mathew Njoroge, Liezl Krugmann, Kelly Chibale   +5 more
wiley   +1 more source

Physiologically Based Pharmacokinetic (PBPK) Modeling to Predict CYP3A-Mediated Drug Interaction between Saxagliptin and Nicardipine: Bridging Rat-to-Human Extrapolation

Pharmaceutics
The aim of this study was to predict the cytochrome P450 3A (CYP3A)-mediated drug–drug interactions (DDIs) between saxagliptin and nicardipine using a physiologically based pharmacokinetic (PBPK) model.
Jeong-Min Lee, Jin-Ha Yoon, Han-Joo Maeng, Yu Chul Kim   +3 more
doaj   +1 more source

Comparison of dermal and inhalation routes of entry for organic chemicals [PDF]

The quantitative comparison of the chemical concentration inside the body as the result of a dermal exposure versus an inhalation exposure is useful for assessing human health risks and deciding on an appropriate protective posture.
Clewell, Harvey J., III, Jepson, Gary W., Mcdougal, James N.   +2 more
core   +1 more source

Physiologically-based pharmacokinetic and toxicokinetic models for estimating human exposure to five toxic elements through oral ingestion [PDF]

, 2017
Biological monitoring and physiologically-based pharmacokinetic (PBPK) modelling are useful complementary tools in quantifying human exposure to elements in the environment.
Alloway, Amzal, ATSDR, Bailey, Bechet, Berglund, Brown, Buchet, Choudhury, Chris Collins, Clewell, Coelho, De Flora, El-Masri, Environment Agency, Eric Dede, Evans, Finley, Fleming, Fransson, Horak, Hsieh, Hughes, Hwang, John W. Cherrie, Ju, Kelly, Kerger, Kirman, Kjellstrom, Krishnan, Leggett, Liao, Lyons, MacMillan, Mann, Marcus J. Tindall, McNeely, McNeely, Morisawa, Nielsen, Nordberg, O’Flaherty, O’Flaherty, O’Flaherty, Paustenbach, Prakash, R Core Team, Rabinowitz, Ruiz, Sasso, Schmitt, Steve Hankin, Sunderman, Walther, Wen, White, Yu, Yu   +58 more
core   +1 more source

A Review of Virtual Twins in Physiologically‐Based Pharmacokinetic Modeling and Simulation

Clinical Pharmacology &Therapeutics, EarlyView.
The novel application of Virtual Twins (VT) in PBPK (VT‐PBPK) presents the opportunity to advance precision dosing and accelerate the shift from one‐size‐fits‐all to targeted, individualized treatments. This review aims to: (1) critically evaluate existing research on the use of VTs in PBPK, (2) develop a conceptual definition of VT‐PBPK, (3) describe ...
Emily Mannix, Sam Mostafa, Amin Rostami‐Hodjegan, Thomas M. Polasek, Carl M. J. Kirkpatrick   +4 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