Handbook - COT FSA PBPK for Regulators Workshop 2021

Abbreviations and References - Handbook 2021 Workshop

Last updated: 11 April 2024

Abbreviations

ADME

Absorption, Distribution, Metabolism and Excretion

AOP

Adverse Outcome Pathway

ATSDR

Agency for Toxic Substances and Disease Registry

BMDL

Benchmark Dose Level

COT

Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment

DDI

Drug-drug interaction

EFPIA

European Federation of Pharmaceutical Industries and Associations

EFSA

European Food Safety Authority

EMA

European Medicines Agency

EURL-ECVAM

European Union Reference Laboratory for Alternatives to Animal Testing

FSA

Food Standards Agency

HBM

Human Biomonitoring

HESI

Health and Environmental Sciences Institute

Httk

High-Throughput Toxicokinetics

ICF

IndusChemFate

ICH

International Council for Harmonisation

ILSI

International Life Sciences Institute

IMED

Innovative Medicines

IPCS

International Programme on Chemical Safety

ISI

The Institute for Scientific Information

JECFA

Joint Food and Agriculture Organisation/World Health Expert Committee on Food Additives

JMPR

Joint Food and Agriculture Organisation/World Health Expert Committee on Pesticide Residues

LJMU

Liverpool John Moores University

MoA

Mode of Action

NAMs

New Approach Methodologies

NOAEL

No-observed-adverse-effect-level

OECD

Organisation for Economic Cooperation and Development OSHA

OECD

Organisation for Economic Cooperation and Development OSHA

PBPK

Physiologically based Pharmacokinetic Modelling

PFOA

Perfluorooctanoic acid

(Q)SAR

(Quantitative-) Structure Activity Relationship SERD

TD

Toxicodynamic

TK

Toxicokinetic

US EPA

United States Environmental Protection Agency US FDA

TD

Toxicodynamic

WHO

World Health Organisation

References

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Bossier, H., Chau, J., Ndour, C., Varewyck, M., Verbeke, T. and Vergucht, S. (2020) A Web-based open source tool for Toxicokinetic and Toxicodynamic modelling. EFSA Supporting Publication: EN-1926. Available at: A Webbased open source tool for Toxicokinetic and Toxicodynamic modelling | EFSA (europa.eu). Accessed: 17/11/2020.

IPCS. (2005) Principles of characterizing and applying human exposure models. Geneva, World Health Organisation, International Programme on Chemical Safety. Harmonisation Project Document No. 3; pp.67. Available at: Principles of characterizing and applying human exposure models (who.int) Accessed: 28/10/2020.

OECD. (2005) Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment. OECD Series on Testing and Assessment Number 34. OECD Guidance Document 34: Validation and International Acceptance of New or Updated Internationally Acceptable Test Methods for Hazard Assessment (nih.gov) Accessed: 17/11/2020.

Paini, A., Leonard, J. A., Kliment, T., Tan, Y-M. and Worth, A. (2017) Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications. Regulatory Toxicology and Pharmacology 90, pp. 104-115.

Parish, S. T., Aschner, M., Casey, W., Corvaro, M., Embry, M. R., Fitzpatrick, S., Kidd, D., Kleinstreuer, N. C., Lima, B, S., Settivari, R. S., Wolf, D. C., Yamazaki, D. and Boobis, A. (2020) An evaluation framework for new approach methodologies (NAMs) for human health safety assessment. Regulatory Toxicology and Pharmacology 111, 104592.

Pletz, J., Blakeman, S., Paini, A., Parissis, N., Worth, A., Andersson, A-M., Frederiksen, H., Sakhi, A. K., Thomsen, C. and Bopp, S. K. (2020) Physiologically based kinetic (PBK) modelling and human biomonitoring data for mixture risk assessment. Environment International 143, 105978.

Rietjens, I. M. C. M., Louisse, J. and Punt, A. (2011) Tutorial on physiologically based kinetic modelling in molecular nutrition and food research. Molecular Nutrition and Food Research 55(6), pp. 941-956.

Sager, J. E., Yu, J., Raguneneau-Majlessi, I. and Isoherran, N. (2015) Physiologically based pharmacokinetic (PBPK) modelling and simulation approaches: A systematic review of published models, applications, and model verification. Drug Metabolism and Disposition 34; pp. 1823-1837.

Tan, Y-M., Chan, M., Chukwudebe, A., Domoradzki, J., Fisher, J., Hack, C. E., Hinderliter, P., Hirasawa, K., Leonard, J., Lumen, A., Paini, A., Qian, H., Ruiz, P., Wambaugh, J., Zhang, F. and Embry. M. (2020) PBPK Model reporting template for chemical risk assessment applications. Regulatory Toxicology and Pharmacology 115, 104691.

Teorell, T. (1937) Kinetics of distribution of substances administered to the body. I & II. Archives internationales de pharmacodynamie et de therapie 57, pp. 205-240. ISSN 0003-9780.

US EPA. (2006) Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (Final Report). U.S. Environmental Protection Agency, Washington, D.C., EPA/600/R-05/043F, 2006: Approaches For the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data In Risk Assessment (Final Report) | Risk Assessment Portal | US EPA Accessed: 28/10/2020.

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