Results 51 to 60 of about 10,433 (192)

PBPK modelling of inter-individual variability in the pharmacokinetics of environmental chemicals [PDF]

, 2010
International audienceGeneric PBPK models, applicable to a large number of substances, coupled to parameter databases and QSAR modules, are now available for predictive modelling of inter-individual variability in the absorption, distribution, metabolism
Bois, Frédéric Y., Clewell, Harvey J., Jamei, Massoud   +2 more
core   +2 more sources

Translation of a physiologically‐based pharmacokinetic model for dabigatran etexilate to the design of a safety and efficacy study in post‐partum women

British Journal of Clinical Pharmacology, EarlyView.
Aims To translate a PBPK model developed for the direct oral anticoagulant, dabigatran etexilate, the prodrug of dabigatran, based on data obtained from healthy men to healthy non‐pregnant, pregnant and post‐partum women. To evaluate safety and efficacy of dabigatran etexilate in post‐partum women using simulations and design a future clinical study to
Kayode Ogungbenro, Lorna Aucott, Farhad Kamali, Paul Ayuk   +3 more
wiley   +1 more source

Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling—A Contribution from the ConcePTION Project

Pharmaceutics, 2023
Women commonly take medication during lactation. Currently, there is little information about the exposure-related safety of maternal medicines for breastfed infants.
Nina Nauwelaerts, Julia Macente, Neel Deferm, Rodolfo Hernandes Bonan, Miao-Chan Huang, Martje Van Neste, David Bibi, Justine Badee, Frederico S. Martins, Anne Smits, Karel Allegaert, Thomas Bouillon, Pieter Annaert   +12 more
doaj   +1 more source

Enhanced Vatiquinone Bioavailability With Fatty Meals and Optimal Dosing Schedule

Biopharmaceutics &Drug Disposition, EarlyView.
This investigation discusses two clinical studies. One investigated the effect of fatty meals (≥ 25% fat) on vatiquinone PK exposures, and the other one characterized vatiquinone PK profiles when administered on a TID dosing regimen corresponding to mealtimes. The data support the recommendation of administering vatiquinone with fatty meals (≥ 25% fat)
Lucy Lee, Katsuyuki Murase, Martin Thoolen, Peter Giannousis, Diksha Kaushik, Lee Golden, Ronald Kong   +6 more
wiley   +1 more source

Approaches to conducting a physiologically relevant test (PRT) in the study of medicines containing substance IIc of the BCS subclass using sorafenib as an example

Разработка и регистрация лекарственных средств
Introduction. Sorafenib is an antineoplastic drug belonging to class IIc according to the biopharmaceutical classification system (BCS) due to the presence of both acidic and basic properties.
A. V. Suvorova, Yu. V. Medvedev, P. A. Losenkova, O. S. Kramarenko, E. A. Malashenko, A. M. Poluyanov, I. E. Shohin   +6 more
doaj   +1 more source

HD Physiology Project-Japanese efforts to promote multilevel integrative systems biology and physiome research. [PDF]

, 2017
The HD Physiology Project is a Japanese research consortium that aimed to develop methods and a computational platform in which physiological and pathological information can be described in high-level definitions across multiple scales of time and size.
for HD physiology project investigators, Furutani, Kazuharu, Kurachi, Yoshihisa, Tsumoto, Kunichika   +3 more
core  

Physiologically based pharmacokinetic and pharmacodynamic modeling of an antagonist (SM‐406/AT‐406) of multiple inhibitor of apoptosis proteins (IAPs) in a mouse xenograft model of human breast cancer [PDF]

, 2013
The inhibitors of apoptosis proteins (IAPs) are a class of key apoptosis regulators overexpressed or dysregulated in cancer. SM‐406/AT‐406 is a potent and selective small molecule mimetic of Smac that antagonizes the inhibitor of apoptosis proteins (IAPs)
Baxter, Bissery, Brown, Cai, Cao, Chai, D'Argenio, Dai, Derendorf, Deveraux, Du, Hanahan, Holcik, Laufer, Liu, Lowe, Martinez-Ruiz, Nestorov, Nicholson, Norton, Ponder, Roth, Salphati, Salvesen, Shiozaki, Simeoni, Srinivasula, Verhagen, Wang, Xu, Yamazaki, Zhang   +31 more
core   +1 more source

Assessment of Pharmacokinetic Drug Interaction of Asciminib with Atorvastatin in Healthy Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Asciminib is the first BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP) in patients with chronic myeloid leukemia. This phase 1, two‐treatment‐period, drug‐drug interaction study evaluated the effect of steady‐state asciminib on the pharmacokinetics of atorvastatin.
Matthias Hoch, Wendy Weis, Felix Huth, Seshulatha Jamalapuram, Michelle Quinlan, Amarnath Bandaru, Suleyman Eralp Bellibas, Asmae Mirkou, Shruti Kapoor, Shefali Kakar   +9 more
wiley   +1 more source

Rules of Thumb for Estimating Drug Levels in Breast Milk: How Well Do They Work?

Clinical Pharmacology &Therapeutics, EarlyView.
The American Academy of Pediatrics and the World Health Organization recommend exclusive breastfeeding for the first 6 months of life due to extensive benefits for the maternal–infant dyad. While over 90% of mothers initiate breastfeeding, continuation drops to 35% by 6 months, often due to concerns about medication safety.
Juliya Gasparyan, Philip O. Anderson, Tamorah Lewis, Cindy H. T. Yeung   +3 more
wiley   +1 more source

Chemical risk assessment in food animals via physiologically based pharmacokinetic modeling − Part I: Veterinary drugs on human food safety assessment

Environment International
Veterinary drugs and environmental pollutants can enter food animals and remain as residues in food chains threatening human food safety and health.
Kun Mi, Xue Wu, Zhoumeng Lin
doaj   +1 more source