Results 31 to 40 of about 12,447 (257)

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria [PDF]

, 2017
Majority of bioequivalence studies are conducted in healthy volunteers. It has been argued that bioequivalence may not necessarily hold true in relevant patient populations due to a variety of reasons which affect one formulation more than the other for ...
Darwich Adam S., Doki Kosuke, Patel Nikunjkumar, Rostami-Hodjegan Amin, 土岐 浩介   +4 more
core   +1 more source

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

Integration of Genome Scale Metabolic Networks and gene regulation of metabolic enzymes with Physiologically Based Pharmacokinetics [PDF]

, 2017
The scope of Physiologically Based Pharmacokinetic (PBPK) modelling can be expanded by assimilation of the mechanistic models of intracellular processes from Systems Biology field.
Al Olama, Alimirah, Arshad, Ay, Bailey, Beste, Blätke, Bordbar, Cannon, Covert, Covert, El-Sankary, Fell, Fisher, Giacomantonio, Gibson, Gille, Goss, Guebila, Heino, Huang, Huang, Huizenga, Jain, Jin, Jones, Kobayashi, Kolodkin, Kotas, Krauss, Lee, Lewis, Mark, Matsuno, Murata, Oakley, Orth, Pascussi, Plant, Reul, Schellenberger, Schilling, Schuster, Shmulevich, Steggles, Stephanopoulos, Varma, Watkins, Wienkers, Wu, Xiao, Zhang   +51 more
core   +2 more sources

Developing a Physiologically-Based Pharmacokinetic Model Knowledgebase in Support of Provisional Model Construction.

PLoS Computational Biology, 2016
Developing physiologically-based pharmacokinetic (PBPK) models for chemicals can be resource-intensive, as neither chemical-specific parameters nor in vivo pharmacokinetic data are easily available for model construction.
Jingtao Lu, Michael-Rock Goldsmith, Christopher M Grulke, Daniel T Chang, Raina D Brooks, Jeremy A Leonard, Martin B Phillips, Ethan D Hypes, Matthew J Fair, Rogelio Tornero-Velez, Jeffre Johnson, Curtis C Dary, Yu-Mei Tan   +12 more
doaj   +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

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

Physiologically Based Pharmacokinetic (PBPK) Modeling to Predict CYP3A-Mediated Drug Interaction between Saxagliptin and Nicardipine: Bridging Rat-to-Human Extrapolation

Pharmaceutics
The aim of this study was to predict the cytochrome P450 3A (CYP3A)-mediated drug–drug interactions (DDIs) between saxagliptin and nicardipine using a physiologically based pharmacokinetic (PBPK) model.
Jeong-Min Lee, Jin-Ha Yoon, Han-Joo Maeng, Yu Chul Kim   +3 more
doaj   +1 more source

Predicting Resolvin D1 Pharmacokinetics in Humans with Physiologically‐Based Pharmacokinetic Modeling

Clinical and Translational Science, 2021
Sjögren’s syndrome (SS) is an autoimmune disease with no effective treatment options. Resolvin D1 (RvD1) belongs to a class of lipid‐based specialized pro‐resolving mediators that showed efficacy in preclinical models of SS.
Venkata K. Yellepeddi, Kaustubh Parashar, Spencer M. Dean, Kevin M. Watt, Jonathan E. Constance, Olga J. Baker   +5 more
doaj   +1 more source

Mechanistic Coupling of a Novel in silico Cotyledon Perfusion Model and a Physiologically Based Pharmacokinetic Model to Predict Fetal Acetaminophen Pharmacokinetics at Delivery

Frontiers in Pediatrics, 2021
Little is known about placental drug transfer and fetal pharmacokinetics despite increasing drug use in pregnant women. While physiologically based pharmacokinetic (PBPK) models can help in some cases to shed light on this knowledge gap, adequate ...
Paola Mian, Bridget Nolan, Bridget Nolan, John N. van den Anker, John N. van den Anker, Kristel van Calsteren, Kristel van Calsteren, Karel Allegaert, Karel Allegaert, Karel Allegaert, Nisha Lakhi, Nisha Lakhi, André Dallmann   +12 more
doaj   +1 more source

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   +3 more sources