Results 71 to 80 of about 13,844,580 (194)

Model‐Informed Evaluation of Hydroxyurea Exposure During Lactation

Clinical Pharmacology &Therapeutics, EarlyView.
Hydroxyurea is a cornerstone therapy for sickle cell anemia; however, evidence guiding its use during lactation remains limited. This study aimed to develop a population pharmacokinetic (PK) model to characterize hydroxyurea disposition in maternal plasma and breast milk, and to quantify infant exposure under clinically relevant breastfeeding scenarios.
Anhar Hosawi, Kei Irie, Min Dong, Julie Ware, Russell Ware, Tomoyuki Mizuno   +5 more
wiley   +1 more source

Physiologically-based pharmacokinetic/pharmacodynamic modeling of meropenem in critically ill patients

Scientific Reports
This study aimed to develop a physiologically based pharmacokinetic/pharmacodynamic model (PBPK/PD) of meropenem for critically ill patients. A PBPK model of meropenem in healthy adults was established using PK-Sim software and subsequently extrapolated ...
Yujie Yang, Yirong Wang, Wei Zeng, Jinhua Zhou, Min Xu, Ying Lan, Lvye Liu, Jian Shen, Chuan Zhang, Qin He   +9 more
doaj   +1 more source

Integrated assessment of rifampicin‐mediated induction of transporters and drug‐metabolizing enzymes in a long‐term human liver tissue chip system

Clinical Pharmacology &Therapeutics, EarlyView.
Rifampicin is a prototypical clinical inducer used in drug–drug interaction (DDI) studies. However, the clinical relevance and predictability of rifampicin‐mediated hepatic transporter induction remain poorly defined. Conventional hepatocyte culture models fail to capture clinically relevant regulation of transporters and drug‐metabolizing enzymes ...
Mattie E. Hartauer, Raeanne M. Lanphier, Shivam Ohri, Jessica Snyder, Jacqueline B. Tiley, John K. Fallon, Henry Ho, Murat Cirit, Shiny Amala Priya Rajan, Kim L. R. Brouwer   +9 more
wiley   +1 more source

Do Brain Extracellular Fluid Concentrations Predict PET‐Inferred Receptor Occupancy in Human CNS? A Mechanistic Model‐Based Analysis of Dopamine D2 Receptor Ligands

Clinical Pharmacology &Therapeutics, EarlyView.
A mechanistic CNS PBPK model framework was applied to eight antipsychotic D2 receptor ligands, comparing brain extracellular fluid (brainECF) and brain cell membrane (brainM) as biophase for predicting human receptor occupancy compared against PET neuroimaging data. BrainM concentrations showed improved agreement with PET‐derived receptor occupancy for
Divakar Budda, J.G. Coen van Hasselt, Elizabeth C.M. de Lange   +2 more
wiley   +1 more source

Structure of pregnancy physiologically based pharmacokinetic (p-PBPK) model.

, 2015
Structure of pregnancy physiologically based pharmacokinetic (p-PBPK) model.
Saeed Alqahtani (802779), Amal Kaddoumi (802780)   +1 more
core   +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

Expanded Physiologically‐Based Pharmacokinetic Model of Rifampicin for Predicting Interactions With Drugs and an Endogenous Biomarker via Complex Mechanisms Including Organic Anion Transporting Polypeptide 1B Induction

CPT: Pharmacometrics & Systems Pharmacology, 2019
As rifampicin can cause the induction and inhibition of multiple metabolizing enzymes and transporters, it has been challenging to accurately predict the complex drug–drug interactions (DDIs).
Ryuta Asaumi, Karsten Menzel, Wooin Lee, Ken‐ichi Nunoya, Haruo Imawaka, Hiroyuki Kusuhara, Yuichi Sugiyama   +6 more
doaj   +1 more source

Long‐Acting Therapeutics in Pediatric Health: Bridging Innovation and Access

Clinical Pharmacology &Therapeutics, EarlyView.
Children have distinct therapeutic needs arising from age‐dependent physiology, disease epidemiology, formulation requirements, dosing considerations, and safety vulnerabilities. Despite substantial reductions in childhood mortality over the past three decades, nearly 5 million children under five died in 2023, with infectious diseases continuing to ...
Prajith Venkatasubramanian, Moherndran Archary, Daniel B. Hawcutt, Rachel Daley, Edmund Capparelli, Adeniyi Olagunju   +5 more
wiley   +1 more source

Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling

CPT: Pharmacometrics & Systems Pharmacology
Physiologically based pharmacokinetic (PBPK) modeling is a mechanistic cornerstone of model‐informed drug development (MIDD), providing evidence for regulatory decisions.
Marylore Chenel, Andre Dallmann, Ibrahim Ince, Michaela Meyer, Jan‐Frederik Schlender, Donato Teutonico, Erik Sjögren   +6 more
doaj   +1 more source

Physiologically Based Pharmacokinetic Modeling to Assess Transporter‐Mediated Drug–Drug Interactions in Support of Labeling Recommendations for Zavegepant Nasal Spray

Clinical Pharmacology &Therapeutics, EarlyView.
Zavegepant nasal spray, a calcitonin gene‐related peptide receptor antagonist indicated for acute treatment of migraine with or without aura in adults, is a substrate for organic anion transporting polypeptide 1B3 (OATP1B3), Na+/taurocholate cotransporting polypeptide (NTCP), P‐glycoprotein (P‐gp), and cytochrome P450 3A4 (CYP3A4).
Alice Ke, Ernesto Callegari, Manthena V.S. Varma, Mayur K Ladumor, Chieko Muto, Richard J. Bertz, Hannah M. Jones, Vaishali Sahasrabudhe, Jing Liu   +8 more
wiley   +1 more source