Results 71 to 80 of about 12,486 (248)

From PK/PD to QSP: Understanding the Dynamic Effect of Cholesterol-Lowering Drugs on Atherosclerosis Progression and Stratified Medicine [PDF]

, 2016
Current computational and mathematical tools are demonstrating the high value of using systems modeling approaches (e.g. Quantitative Systems Pharmacology) to understand the effect of a given compound on the biological and physiological mechanisms ...
Diaz-Zuccarini, V, Pichardo-Almarza, C
core  

Quantitative Systems Toxicology Modeling with DILIsym to Support Phase 3 Dose Selection for Fezolinetant

Clinical Pharmacology &Therapeutics, EarlyView.
Fezolinetant is a first‐in‐class, selective, non‐hormonal, neurokinin 3 receptor antagonist that is approved for the treatment of moderate to severe vasomotor symptoms due to menopause. In a phase 2b clinical study (n = 352), nine study participants experienced elevations in serum transaminases exceeding three times the upper limit of normal.
Jace C. Nielsen, Jeffrey L. Woodhead, Brett A. Howell, Lisl K. M. Shoda, Dolly A. Parasrampuria, Jiayin Huang, Megumi Iwai, Faith D. Ottery, Xuegong Wang, Marci English, Kentaro Miyazaki, Paul B. Watkins   +11 more
wiley   +1 more source

Integrated PBPK-EO modeling of osimertinib to predict plasma concentrations and intracranial EGFR engagement in patients with brain metastases

Scientific Reports
The purpose of this study was to develop and validate a physiologically based pharmacokinetic (PBPK) model combined with an EGFR occupancy (EO) model for osimertinib (OSI) to predict plasma trough concentration (Ctrough) and the intracranial time-course ...
Feng Liang, Yimei Zhang, Qian Xue, Xiaoling Zhang   +3 more
doaj   +1 more source

Simulating Intestinal Transporter and Enzyme Activity in a Physiologically Based Pharmacokinetic Model for Tenofovir Disoproxil Fumarate [PDF]

, 2017
Tenofovir disoproxil fumarate (TDF), a prodrug of tenofovir, has oral bioavailability (25%) limited by intestinal transport (P-glycoprotein), and intestinal degradation (carboxylesterase). However, the influence of luminal pancreatic enzymes is not fully
Domanico, P, Hobson, J, Moss, DM, Owen, A, Rajoli, RKR, Randolph, R, Rannard, S, Seonghee, P, Siccardi, M, Watkinson, M, Wring, S   +10 more
core   +1 more source

Advancing Maternal Health with Long‐Acting Therapeutics: Priorities, Efficacy and Safety Considerations, and Emerging Technologies

Clinical Pharmacology &Therapeutics, EarlyView.
Maternal health remains a critical global concern, particularly in underserved populations and in low‐ and middle‐income countries where access to safe and effective therapeutics is limited. Despite the use of medications by most women during pregnancy, the exclusion of pregnant and lactating women from clinical trials has resulted in significant data ...
Rachel K. Scott, Sharon Nachman, Ethel D. Weld, Rachel Daley, Shakir Atoyebi, Robert Bies, Catriona Waitt, Adeniyi Olagunju   +7 more
wiley   +1 more source

Physiologically Based Pharmacokinetic Modeling of Oxcarbazepine to Characterize Its Disposition in Children with Obesity

The Journal of Clinical Pharmacology, EarlyView.
Abstract Oxcarbazepine (OXC) is a second‐generation antiseizure medication, effective through its active metabolite, 10‐mono‐hydroxy derivative (MHD). OXC is used as adjunctive therapy for focal‐onset and primary generalized tonic–clonic seizures, with recommended dosing based on age and body weight.
Patricia D. Maglalang, Jaydeep Sinha, Victόria Etges Helfer, Andrea Edginton, Kanecia Zimmerman, Chi Dang Hornik, William J. Muller, Mobeen Rathore, Daniel K. Benjamin Jr., Jia‐Yuh Chen, Ravinder Anand, Daniel Gonzalez, the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee   +12 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

A combined in vitro/in silico approach to identifying off-target receptor toxicity [PDF]

, 2018
Many xenobiotics can bind to off-target receptors and cause toxicity via the dysregulation of downstream transcription factors. Identification of subsequent off-target toxicity in these chemicals has often required extensive chemical testing in animal ...
Colley, H, leedale, J, Mason, C, Murdoch, C, Norton, A, Peeney, D, Sathish, J, Sharkey, K, Sharma, P, Webb, SD   +9 more
core   +4 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

Machine Learning for Predictive Modeling in Nanomedicine‐Based Cancer Drug Delivery

Med Research, EarlyView.
The integration of AI/ML into nanomedicine offers a transformative approach to therapeutic design and optimization. Unlike conventional empirical methods, AI/ML models (such as classification, regression, and neural networks) enable the analysis of complex clinical and formulation datasets to predict optimal nanoparticle characteristics and therapeutic
Rohan Chand Sahu, Sanchit Arora, Dinesh Kumar, Ashish Kumar Agrawal   +3 more
wiley   +1 more source