Results 61 to 70 of about 14,687 (252)

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

ZeroPM piece 12 PBPK modelling

ZeroPM Pieces, 2022
ZeroPM piece 12 about PBPK modelling. The presentation can be viewed as a film on the ZeroPM youtube channel.
openaire   +1 more source

Population pharmacokinetic modelling of amoxicillin in human breast milk—A contribution from the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Aims Amoxicillin, a widely used β‐lactam antibiotic, requires improved pharmacokinetic characterization during breastfeeding. This study used a population pharmacokinetic (PopPK) approach to model amoxicillin concentrations in breast milk, identify variability sources and estimate infant exposure, applying worst‐case scenarios.
Sarah Baklouti, Virginie Rigourd, Alice Panchaud, Hedvig Nordeng, Karel Allegaert, Pieter Annaert, Miao‐Chan Huang, Anaelle Monfort, Monia Guidi, Peggy Gandia   +9 more
wiley   +1 more source

Increasing application of pediatric physiologically based pharmacokinetic models across academic and industry organizations

CPT: Pharmacometrics & Systems Pharmacology, 2022
There has been a significant increase in the use of physiologically based pharmacokinetic (PBPK) models during the past 20 years, especially for pediatrics.
Trevor N. Johnson, Ben G. Small, Karen Rowland Yeo   +2 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  

Assessing transporter‐mediated rifampin–linezolid interaction using physiologically‐based pharmacokinetic modelling

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims The study aims to develop a physiologically‐based pharmacokinetic (PBPK) model to quantitatively evaluate the role of ATP‐binding cassette sub‐family B member 1 (ABCB1) and ATP‐binding cassette super‐family G member 2 (ABCG2) in the drug–drug interaction (DDI) between rifampin and linezolid and to predict the impact of high‐dose rifampin ...
Hoang Dat Nguyen, Vinh Hoa Pham, Richard M. Hoglund, Joel Tarning, Junjie Ding   +4 more
wiley   +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

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

British Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +3 more
wiley   +1 more source

The quantitative impact of metabolism‐inhibiting drugs on the occurrence of adverse drug reactions—A backward selection approach

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The quantitative effect of several inhibitory drugs on the development of adverse drug reactions (ADRs) is currently difficult to estimate. Our aim was to identify metabolic pathways, which, when inhibited, increase the risk for certain ADRs, and to use this system to consider comedication at individual level. Methods Data of a prospective
Judith Berres, Justyna Wozniak, Hannah Fölsch, Anja Knueppel‐Ruppert, Verena Graeff, Andrea Kriegisch‐Stumpf, Harald Dormann, Julia C. Stingl, Katja S. Just   +8 more
wiley   +1 more source

A Mechanistic, Model-Based Approach to Safety Assessment in Clinical Development [PDF]

, 2012
Peer ...
Becker, T, Brosch, M, Görlitz, L, Hampe, J, Kuepfer, L, Laffert, B, Lippert, J, Meyer, M, Neuvonen, PJ, Niemi, M, Schafmayer, C, Schreiber, S, Siegmund, H.-U, von Kampen, O   +13 more
core   +1 more source