Results 81 to 90 of about 16,022 (277)

Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making

Pharmaceutics, 2021
Atorvastatin (ATS) is the gold-standard treatment worldwide for the management of hypercholesterolemia and prevention of cardiovascular diseases associated with dyslipidemia.
Javier Reig-López, Alfredo García-Arieta, Víctor Mangas-Sanjuán, Matilde Merino-Sanjuán   +3 more
doaj   +1 more source

Building Pharmacoequity through Student and Trainee Education, Service, and Global Outreach

Clinical Pharmacology &Therapeutics, EarlyView.
Students and trainees are integral to clinical pharmacology, as they have the potential to shape the field. This perspective highlights how the ASCPT Student and Trainee Community engages members worldwide, providing opportunities and resources to advance scientific and professional development.
Chazmyn Riley, Natasha Desiree Casas, Patricia D. Maglalang, Hongyu Su, An Le, Shravani Etrouth, Shayna R. Killam, MaryPeace McRae   +7 more
wiley   +1 more source

A Physiologically-Based Pharmacokinetic (PBPK) Model Network for the Prediction of CYP1A2 and CYP2C19 Drug–Drug–Gene Interactions with Fluvoxamine, Omeprazole, S-mephenytoin, Moclobemide, Tizanidine, Mexiletine, Ethinylestradiol, and Caffeine

Pharmaceutics, 2020
Physiologically-based pharmacokinetic (PBPK) modeling is a well-recognized method for quantitatively predicting the effect of intrinsic/extrinsic factors on drug exposure.
Tobias Kanacher, Andreas Lindauer, Enrica Mezzalana, Ingrid Michon, Celine Veau, Jose David Gómez Mantilla, Valerie Nock, Angèle Fleury   +7 more
doaj   +1 more source

An IQ Consortium Perspective on the FDA Guidance for Assessment of Pharmacokinetics in Participants With Impaired Renal Function

Clinical Pharmacology &Therapeutics, EarlyView.
The FDA published guidance on assessing pharmacokinetics (PK) in participants with impaired renal function in 2024. The IQ CPLG Organ Impairment Working Group summarized the industry’s perspective on this guidance by highlighting a few key updates in the 2024 guidance, including: (1) the recommendation of using estimated glomerular filtration rate ...
Yan Jin, Ashish Sharma, Mariam A. Ahmed, Sravanthi Cheeti, Ying Ou, Damayanthi Devineni, Yizhe Chen, Jitendra S. Kanodia, Yasmeen Abouelhassan, Nadia Noormohamed, Jin Zhou, Patrick Marroum, Vaishali Sahasrabudhe, Islam R. Younis   +13 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

Physiologically Based Pharmacokinetic Modeling of Caffeine in Preterm Neonates: Influence of Renal Function and Impairment on Dosing. [PDF]

J Clin Pharmacol
Abstract Currently, the same weight‐based caffeine citrate dosing regimen is applied to all neonates. However, due to differences in growth trajectories by gestational age (GA) and altered caffeine elimination in neonates with renal injury, optimal dosing regimens may differ. In this study, we refined the existing physiologically based pharmacokinetic (
Thomas N, Harer MW, Lim SY.
europepmc   +2 more sources

Cutting Edge PBPK Models and Analyses: Providing the Basis for Future Modeling Efforts and Bridges to Emerging Toxicology Paradigms [PDF]

, 2012
Physiologically based Pharmacokinetic (PBPK) models are used for predictions of internal or target dose from environmental and pharmacologic chemical exposures.
Jane C. Caldwell, Kannan Krishnan, Marina V. Evans   +2 more
core   +1 more source

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK [PDF]

CPT: Pharmacometrics & Systems Pharmacology, 2015
The US Food and Drug Administration (FDA) public workshop, entitled “Application of Physiologically‐based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions ...
Wagner, C, Zhao, P, Pan, Y, Hsu, V, Grillo, J, Huang, SM, Sinha, V   +6 more
openaire   +2 more sources

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

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