Results 41 to 50 of about 10,433 (192)

Human Food Safety Implications of Variation in Food Animal Drug Metabolism [PDF]

, 2016
Citation: Lin, Z., Vahl, C. I., & Riviere, J. E. (2016). Human Food Safety Implications of Variation in Food Animal Drug Metabolism. Scientific Reports, 6.
Lin, Zhoumeng, Riviere, Jim E., Vahl, Christopher I.   +2 more
core   +1 more source

PBPK Modeling on Organs-on-Chips: An Overview of Recent Advancements

Frontiers in Bioengineering and Biotechnology, 2022
Organ-on-a-chip (OoC) is a new and promising technology, which aims to improve the efficiency of drug development and realize personalized medicine by simulating in vivo environment in vitro.
Yi Yang, Yin Chen, Liang Wang, Shihui Xu, Guoqing Fang, Xilin Guo, Zaozao Chen, Zaozao Chen, Zhongze Gu, Zhongze Gu   +9 more
doaj   +1 more source

Modélisation physiologique des interactions métaboliques [PDF]

, 2009
National audienceModeling metabolic interactions between chemicals can be a task of formidable complexity. Here I present a new approach and new tools to facilitate that development.
Bois, Frédéric Y.
core   +3 more sources

AZD0449, an inhaled JAK1 inhibitor, in healthy participants and patients with mild asthma

British Journal of Clinical Pharmacology, EarlyView.
Aims Inhaled corticosteroids (ICS) plus bronchodilator are recommended for the treatment of asthma. Targeting the JAK1‐dependent pathway may be an alternative for asthma management in patients with incomplete response to ICS. The aim of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD0449, a
Anna Lundahl, Rod Hughes, Joachim Almquist, David Close, Jukka Mäenpää, Ulrika Tehler, Tina Jellesmark Jensen, Szilárd Nemes, Anne‐Kristina Mercier, Zala Jevnikar, Pablo Forte Soto, Dave Singh   +11 more
wiley   +1 more source

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug ...
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao   +17 more
doaj   +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

Pharmacokinetics of teicoplanin in paediatric patients—A systematic review of current literature

British Journal of Clinical Pharmacology, EarlyView.
Background and Objective Teicoplanin is commonly used in children to treat gram‐positive infections and is sometimes used off‐label prophylactically in surgical or paediatric oncology settings. The pharmacokinetics (PK) of teicoplanin in children exhibit considerable variability, such as in critically ill children or those with renal impairment.
Noa E. Wijnen, Daan J. Touw, Kim Klein, Gertjan J. L. Kaspers, Paola Mian   +4 more
wiley   +1 more source

Effect of developmental changes on pharmacokinetics of drugs used in the treatment of infant acute lymphoblastic leukaemia—A comprehensive review

British Journal of Clinical Pharmacology, EarlyView.
While the event‐free survival (EFS) of children treated for acute lymphoblastic leukaemia (ALL) has improved greatly in the last decades, the EFS for patients diagnosed with ALL before the age of one is still under 50%. This outcome further decreases when infants have a rearrangement in the gene encoding histone‐lysine N‐methyltransferase 2A (KMT2A ...
Tirsa de Kluis, Leiah J. Brigitha, Lidwien M. Hanff, Alwin D. R. Huitema, Inge M. van der Sluis, Meta H. M. Diekstra   +5 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

Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk

British Journal of Clinical Pharmacology, EarlyView.
Aims To determine breastmilk concentrations of doravirine via PBPK modelling in combination with a clinical lactation study. As women living with HIV are not able to cease antiretroviral therapy during lactation, it is necessary to establish drug transfer into breastmilk to determine exposure of the infant to antiretroviral drugs and potential risk of ...
Lena van der Wekken‐Pas, David Burger, Rick Greupink, Angela Colbers   +3 more
wiley   +1 more source