Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution

T Burgdorf, A H Piersma, R Landsiedel, R Clewell, N Kleinstreuer, M Oelgeschläger*, B Desprez, A Kienhuis, P Bos, R de Vries, L de Wit, T Seidle, Jesper Scheel, G Schönfelder, J van Benthem, Anne Marie Vinggaard, C Eskes, J Ezendam

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

At a joint workshop organized by RIVM and BfR, international experts from governmental institutes, regulatory agencies, industry, academia and animal welfare organizations discussed and provided recommendations for the development, validation and implementation of innovative 3R approaches in regulatory toxicology. In particular, an evolutionary improvement of our current approach of test method validation in the context of defined approaches or integrated testing strategies was discussed together with a revolutionary approach based on a comprehensive description of the physiological responses of the human body to chemical exposure and the subsequent definition of relevant and predictive in vitro, in chemico or in silico methods. A more comprehensive evaluation of biological relevance, scientific validity and regulatory purpose of new test methods and assessment strategies together with case studies that provide practical experience with new approaches were discussed as essential steps to build up the necessary confidence to facilitate regulatory acceptance.
Original languageEnglish
JournalToxicology in Vitro
Volume59
Pages (from-to)1-11
ISSN0887-2333
DOIs
Publication statusPublished - 2019

Keywords

  • Case studies
  • Evolution
  • Relevance
  • Revolution
  • Validation
  • Workshop

Cite this

Burgdorf, T., Piersma, A. H., Landsiedel, R., Clewell, R., Kleinstreuer, N., Oelgeschläger, M., ... Ezendam, J. (2019). Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution. Toxicology in Vitro, 59, 1-11. https://doi.org/10.1016/j.tiv.2019.03.039
Burgdorf, T ; Piersma, A H ; Landsiedel, R ; Clewell, R ; Kleinstreuer, N ; Oelgeschläger, M ; Desprez, B ; Kienhuis, A ; Bos, P ; de Vries, R ; de Wit, L ; Seidle, T ; Scheel, Jesper ; Schönfelder, G ; van Benthem, J ; Vinggaard, Anne Marie ; Eskes, C ; Ezendam, J. / Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution. In: Toxicology in Vitro. 2019 ; Vol. 59. pp. 1-11.
@article{4dfd284d454443edb0e8ffaa4729dcae,
title = "Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution",
abstract = "At a joint workshop organized by RIVM and BfR, international experts from governmental institutes, regulatory agencies, industry, academia and animal welfare organizations discussed and provided recommendations for the development, validation and implementation of innovative 3R approaches in regulatory toxicology. In particular, an evolutionary improvement of our current approach of test method validation in the context of defined approaches or integrated testing strategies was discussed together with a revolutionary approach based on a comprehensive description of the physiological responses of the human body to chemical exposure and the subsequent definition of relevant and predictive in vitro, in chemico or in silico methods. A more comprehensive evaluation of biological relevance, scientific validity and regulatory purpose of new test methods and assessment strategies together with case studies that provide practical experience with new approaches were discussed as essential steps to build up the necessary confidence to facilitate regulatory acceptance.",
keywords = "Case studies, Evolution, Relevance, Revolution, Validation, Workshop",
author = "T Burgdorf and Piersma, {A H} and R Landsiedel and R Clewell and N Kleinstreuer and M Oelgeschl{\"a}ger and B Desprez and A Kienhuis and P Bos and {de Vries}, R and {de Wit}, L and T Seidle and Jesper Scheel and G Sch{\"o}nfelder and {van Benthem}, J and Vinggaard, {Anne Marie} and C Eskes and J Ezendam",
year = "2019",
doi = "10.1016/j.tiv.2019.03.039",
language = "English",
volume = "59",
pages = "1--11",
journal = "Toxicology in Vitro",
issn = "0887-2333",
publisher = "Pergamon Press",

}

Burgdorf, T, Piersma, AH, Landsiedel, R, Clewell, R, Kleinstreuer, N, Oelgeschläger, M, Desprez, B, Kienhuis, A, Bos, P, de Vries, R, de Wit, L, Seidle, T, Scheel, J, Schönfelder, G, van Benthem, J, Vinggaard, AM, Eskes, C & Ezendam, J 2019, 'Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution', Toxicology in Vitro, vol. 59, pp. 1-11. https://doi.org/10.1016/j.tiv.2019.03.039

Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution. / Burgdorf, T; Piersma, A H; Landsiedel, R; Clewell, R; Kleinstreuer, N; Oelgeschläger, M; Desprez, B; Kienhuis, A; Bos, P; de Vries, R; de Wit, L; Seidle, T; Scheel, Jesper; Schönfelder, G; van Benthem, J; Vinggaard, Anne Marie; Eskes, C; Ezendam, J.

In: Toxicology in Vitro, Vol. 59, 2019, p. 1-11.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution

AU - Burgdorf, T

AU - Piersma, A H

AU - Landsiedel, R

AU - Clewell, R

AU - Kleinstreuer, N

AU - Oelgeschläger, M

AU - Desprez, B

AU - Kienhuis, A

AU - Bos, P

AU - de Vries, R

AU - de Wit, L

AU - Seidle, T

AU - Scheel, Jesper

AU - Schönfelder, G

AU - van Benthem, J

AU - Vinggaard, Anne Marie

AU - Eskes, C

AU - Ezendam, J

PY - 2019

Y1 - 2019

N2 - At a joint workshop organized by RIVM and BfR, international experts from governmental institutes, regulatory agencies, industry, academia and animal welfare organizations discussed and provided recommendations for the development, validation and implementation of innovative 3R approaches in regulatory toxicology. In particular, an evolutionary improvement of our current approach of test method validation in the context of defined approaches or integrated testing strategies was discussed together with a revolutionary approach based on a comprehensive description of the physiological responses of the human body to chemical exposure and the subsequent definition of relevant and predictive in vitro, in chemico or in silico methods. A more comprehensive evaluation of biological relevance, scientific validity and regulatory purpose of new test methods and assessment strategies together with case studies that provide practical experience with new approaches were discussed as essential steps to build up the necessary confidence to facilitate regulatory acceptance.

AB - At a joint workshop organized by RIVM and BfR, international experts from governmental institutes, regulatory agencies, industry, academia and animal welfare organizations discussed and provided recommendations for the development, validation and implementation of innovative 3R approaches in regulatory toxicology. In particular, an evolutionary improvement of our current approach of test method validation in the context of defined approaches or integrated testing strategies was discussed together with a revolutionary approach based on a comprehensive description of the physiological responses of the human body to chemical exposure and the subsequent definition of relevant and predictive in vitro, in chemico or in silico methods. A more comprehensive evaluation of biological relevance, scientific validity and regulatory purpose of new test methods and assessment strategies together with case studies that provide practical experience with new approaches were discussed as essential steps to build up the necessary confidence to facilitate regulatory acceptance.

KW - Case studies

KW - Evolution

KW - Relevance

KW - Revolution

KW - Validation

KW - Workshop

U2 - 10.1016/j.tiv.2019.03.039

DO - 10.1016/j.tiv.2019.03.039

M3 - Journal article

C2 - 30946968

VL - 59

SP - 1

EP - 11

JO - Toxicology in Vitro

JF - Toxicology in Vitro

SN - 0887-2333

ER -