Results 81 to 90 of about 14,363 (238)

Development and evaluation of physiologically based pharmacokinetic drug-disease models for predicting captopril pharmacokinetics in chronic diseases

Scientific Reports, 2021
The advancement in the processing speeds of computing machines has facilitated the development of complex physiologically based pharmacokinetic (PBPK) models.
Muhammad F. Rasool, Shazia Ali, Sundus Khalid, Ramsha Khalid, Abdul Majeed, Imran Imran, Hamid Saeed, Muhammad Usman, Mohsin Ali, Amer S. Alali, Abdullah F. AlAsmari, Nemat Ali, Ali Mohammed Asiri, Fawaz Alasmari, Faleh Alqahtani   +14 more
doaj   +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

A generic framework for the physiologically‐based pharmacokinetic platform qualification of PK‐Sim and its application to predicting cytochrome P450 3A4–mediated drug–drug interactions

CPT: Pharmacometrics & Systems Pharmacology, 2021
The success of applications of physiologically‐based pharmacokinetic (PBPK) modeling in drug development and drug labeling has triggered regulatory agencies to demand rigorous demonstration of the predictive capability of the specific PBPK platform for a
Sebastian Frechen, Juri Solodenko, Thomas Wendl, André Dallmann, Ibrahim Ince, Thorsten Lehr, Jörg Lippert, Rolf Burghaus   +7 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

Advancing Pharmacoequity Globally: Reflections from the ASCPT Development, Regulatory, and Outcomes Network

Clinical Pharmacology &Therapeutics, EarlyView.
ASCPT has a mission to advance clinical pharmacology and translational sciences to reduce health disparities. The development, regulatory, and outcomes (DRO) network within ASCPT strives to advance pharmacoequity globally. Pharmacoequity, coined by Utibe Essien (2021), is the principle that all individuals, regardless of race, ethnicity, geography, or ...
Priya Jayachandran, Mayur K. Ladumor, Georgios Vlasakakis, Andrew Riselli, Katarina V. Ilic, Rob C. van Wijk, Mohamed Elmeliegy, Jatinder Kaur Mukker, Aarti Sawant‐Basak, Tao Long, Juyao Dong, Noha Rayad, Tao Zhang, on behalf of the DRO Network   +13 more
wiley   +1 more source

PBPK Modeling: Empowering Drug Development and Precision Dosing in China

CPT: Pharmacometrics & Systems Pharmacology
Physiologically based pharmacokinetic (PBPK) modeling, a cornerstone of model‐informed drug development and model‐informed precision dosing, simulates drug disposition in the human body by integrating physiological, biochemical, and physicochemical ...
Dongsheng Yang, Jian Li, Wen Yao Mak, Aole Zheng, Xiao Zhu, Qingfeng He, Yuzhu Wang, Xiaoqiang Xiang   +7 more
doaj   +1 more source

Current Approaches and Techniques in Physiologically Based Pharmacokinetic (PBPK) Modelling of Nanomaterials

Nanomaterials, 2020
There have been efforts to develop physiologically based pharmacokinetic (PBPK) models for nanomaterials (NMs). Since NMs have quite different kinetic behaviors, the applicability of the approaches and techniques that are utilized in current PBPK models ...
Wells Utembe, Harvey Clewell, Natasha Sanabria, Philip Doganis, Mary Gulumian   +4 more
doaj   +1 more source

Accelerating Generic Long‐Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access

Clinical Pharmacology &Therapeutics, EarlyView.
The global HIV response aims for widespread availability of affordable, quality‐assured long‐acting antiretroviral (LA ARV) drugs to achieve sustained epidemic control, particularly in low‐ and middle‐income countries. This report summarizes key discussion points, findings, and outcomes from an international workshop on generic LA ARVs, held in ...
Usman Arshad, Lobna Gaayeb, Henry Pertinez, Rajith K. R. Rajoli, Melynda Watkins, Parag Nimbolkar, Simone Perazzolo, Bharat Pagi, Annemarie Wensing, Saye Khoo, Marta Boffito, René Holm, Zack Panos, Imelda Mahaka, Francois Venter, Benny Kottiri, Keith W. Crawford, Rodney J. Y. Ho, Polly Clayden, Paul Domanico, Kimberly Struble, Andrew Owen, Charles Flexner   +22 more
wiley   +1 more source

Unveiling Hepatic Protein Alterations in Neonatal and Infant Biliary Atresia

Clinical Pharmacology &Therapeutics, EarlyView.
Pediatric populations differ from adults in drug elimination capacity. While current scaling methods account for enzyme and transporter maturation, they overlook comorbidities, such as biliary atresia (BA), a liver disease appearing within the first 2–8 weeks of life that can progress to cirrhosis.
Zubida M. Al‐Majdoub, Martyn Howard, Brahim Achour, Jill Barber, Naved Alizai, Amin Rostami‐Hodjegan   +5 more
wiley   +1 more source