COT FSA PBPK for Regulators Workshop Report 2021

References - 2021 Workshop Report

Last updated: 11 April 2024

Blancato, J. N. and Rhomberg, L. (1988) The Impact of Pharmacokinetics on the Risk Assessment of Dichloromethane. US Environmental Protection Agency, Office of Research and Development, Office of Health and Environmental Assessment: IMPACT OF PHARMACOKINETICS ON THE RISK ASSESSMENT OF DICHLOROMETHANE | Risk Assessment Portal | US EPA

Berkley Madonna Website: Berkeley Madonna (berkeley-madonna.myshopify.com)

Bois, F.Y. and Maszle, D.R., 1997. MCSim: a Monte Carlo simulation program. Journal of Statistical Software, 2, pp.1-60.

Clewell, H. J., Gentry, P. R., Gearhart, J. M., Allen, B. C. and Andersen, M. E. (2001) Comparison of cancer risk estimates for vinyl chloride using animal and human data with a PBPK model. Science of the Total Environment 274, pp.37-66.

COT Working Paper On Physiologically Based Pharmacokinetic Modelling
Version 1: [ARCHIVED CONTENT] (nationalarchives.gov.uk)

COT Statement on physiologically based pharmacokinetic modelling (2023)

[ARCHIVED CONTENT] Statement on physiologically based pharmacokinetic modelling | Food Standards Agency (nationalarchives.gov.uk)

COT statement on the COT workshop on evolving approaches to chemical risk assessment: [ARCHIVED CONTENT] COT statement on the COT workshop on evolving approaches to chemical risk assessment | Food Standards Agency (nationalarchives.gov.uk)

COT statement on the COT workshop on 21st century toxicology:

[ARCHIVED CONTENT] COT statement on the COT workshop on 21st century toxicology | Food Standards Agency (nationalarchives.gov.uk)

COT Discussion Paper TOX 2019 34 -Review of physiologically-based pharmacokinetic (PBPK) modelling used for human health risk assessment: Tox-2019-34 PBPK (food.gov.uk)

COT Discussion Paper Case studies: applications of physiologically-based

pharmacokinetic (PBPK) modelling in human health risk assessment:
tox201973pbpkcasesstudies (food.gov.uk)

EFSA. (2014) Scientific Opinion on good modelling practice in the context of mechanistic effect models for risk assessment of plant protection products:
Good modelling practice | EFSA (europa.eu)

ElKhateeb, E., Burkhill, S., Murby, S., Amirat, H., RostamiHodjegan, A. and Ahmad, A., 2021. Physiologicalbased pharmacokinetic modeling trends in pharmaceutical drug development over the last 20years; indepth analysis of applications, organizations, and platforms. Biopharmaceutics & Drug Disposition, 42(4), pp.107-117.

EMA. (2018) Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation: Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation - Scientific guideline | European Medicines Agency (europa.eu) 

INTEGRA Website: INTEGRA – Integrated External and Internal Exposure Modelling Platform – Cefic-Lri

Japanese PMDA. (2020) Guidelines on the use of PBPK model simulations for drug development: 000239317.pdf (pmda.go.jp)

Magnolia Website:Magnolia – Software for Mathematical Modeling and Simulation (magnoliasci.com)

Meek, M. B., Barton, H. A., Bessems, J. G., Lipscomb, J. C. and Krishnan, K. (2013) Case study illustrating the WHO IPCS guidance on characterization and application of physiologically based pharmacokinetic models in risk assessment. Regulatory Toxicology and Pharmacology 66, pp.116-129.

Mielke, H., Abraham, K., Götz, M., Vieth, B., Lampen, A., Luch, A. and Gundert-Remy, U. (2011) Physiologically based toxicokinetic modelling as a tool to assess target organ toxicity in route-to-route extrapolation – The case of coumarin. Toxicology Letters 202, pp. 100-110.

National Research Council. 2007. Toxicity Testing in the 21st Century: A Vision and a Strategy. Washington, DC: The National Academies Press: Toxicity Testing in the 21st Century: A Vision and a Strategy | The National Academies Press

OECD Guidance document on the characterisation, validation and reporting of PBK modes for regulatory purposes (2021): Guidance document on the characterisation, validation and reporting of Physiologically Based Kinetic (PBK) models for regulatory purposes (oecd.org)

Paini, A., Joossens, E., Bessems, J., Desalegn, A., Dorne, J-L., Gosling, J. P., Heringa, M. B., Klaric, M., Kramer, N., Loizou, G., Louisse, J., Lumen, A., Madden, J. C., Patterson, E. A., Proença, S., Punt, A., Setzer, R. W., Suciu, N., Troutman, J., Yoon, M., Worth, A. and Tan, Y. M. (2017) EURL ECVAM Workshop on new generation of physiologically-based kinetic models in risk assessment. EUR 28794 EN, Publications Office of the European Union, Luxembourg. ISBN 978-92-79-73849-4, http://dx.doi.org/10.2760/619902

Pendse, S. N., Efremenko, A., Hack, C. E., Moreau, M., Mallick, P., Dzierlenga, M., Nicolas, C. I., Yoon, M., Clewell, H. J. and McMullen, P. D. (2020) Population Life-course exposure to health effects model (PLETHEM): An R package for PBPK modelling. Computational Toxicology 13, 100115.

Pletz, J. (2021) A mechanistic model to study the kinetics and toxicity of salicylic acid in the kidney of four virtual individuals. Computational Toxicology (Under review).

RVis – Open Access PBPK Modelling Platform:AIMT7: RVis – Open Access PBPK Modelling Platform – Cefic-Lri

SCCS. (2016) Opinion on decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic products: Opinion of the Scientific Committee on Consumer Safety on o-aminophenol (A14) (europa.eu)

SCCS. (2018) The SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation 10th revision:8d49f487-909c-4498-af89-1f769aaa628c_en (europa.eu)

Sympcyp: Certara Simcyp™ PBPK Simulator | Predicting Drug Performance

Tan, Y-M., Worley, R. R., Leonard, J. A. and Fisher, J.W. (2018) Challenges associated with applying physiologically based pharmacokinetic modeling for public health decision-making. Toxicological Sciences 162, pp.341-348.

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.

US FDA. (2018) Physiologically based pharmacokinetic analyses – Format and content Guidance for Industry: Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (fda.gov)

WHO & IPCS. (2010) Characterisation and application of physiologically based pharmacokinetic models in risk assessment: Characterization and application of physiologically based phamacokinetic models in risk assessment (who.int)