Handbook - COT FSA PBPK for Regulators Workshop 2021

Handbook table of contents - 2021 Workshop

Last updated: 11 April 2024

 

About the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT)  3
About the UK Food Standards Agency (FSA)     4
Notes on data and presentations at the workshop 4
    
Preface and workshop objectives
6
PBPK for Regulators Workshop agenda     7
Introduction to physiologically based pharmacokinetic (PBPK) modelling  8
PBPK modelling: Considerations of the COT   14
PBPK models  14
RVis     14
European Food Safety Authority (EFSA): A Web-based open source tool for toxicokinetic (TK) and toxicodynamic (TD) modelling 14
In emerging approaches  16
Cumulative Risk Assessment Approach for Mixtures 16
Current regulatory landscape  17
Questions put forward for the discussion sessions 20
Limitations / Ensuring fit for purpose 20
Potential applications 21

Validation for regulatory application 
21
Duties as regulators 21
Speakers biosketches  22
Professor Alan Boobis OBE    22
Dr Melvin Ernest Andersen PhD, CIH, DABT, ATS  22
Professor Mark Cronin     23
Professor Amin Rostami-Hodjegan PhD, FCP, FAAPS, FJSSX 23
Dr Alexander J. Stevens BSc, MSc, PhD 24
Dr Sheila Annie Peters  25
Dr George Loizou PhD     26
Dr Judith Madden   26
Dr Harvey J. Clewell III PhD, DABT, FATS     27
COT Members  28
COT Secretariat    28
Abbreviations     29
References     30