Evidence-Based Toxicology - The Toolbox of Validation for the 21 st Century?

Research output: Contribution to journalArticle

Abstract

Validation has become a primary driver of the evolution of toxicological methods. Agreement at OECD level currently requires validation of new approaches for consideration in test guideline development. Several examples of this exist. However, the toxicology in the 21st century movement, prompted by the 2007 NRC/NAS vision document, might lead to a revolutionary change in the toxicological toolbox. The challenge is whether the validation process, as it has been formalized over the last two decades, meets the needs for this paradigm shift. The concept of evidence-based medicine (EBM) has emerged from clinical medicine, which retrospectively assesses the evidence of adequacy of a given approach. This is not typically done in prospective studies - the equivalent of validation studies might be multicenter randomized trials. Evidently, where such unambiguous evidence is available, no other assessment is necessary. EBM, however, has developed procedures, including meta-analysis, to collect and evaluate all the available evidence where no such definitive study is available. The recent successful introduction of retrospective validation, i.e. the collection and evaluation of existing evidence from various sources, represents a step in this direction. Here, we will explore new toxicological approaches via evidence-based toxicology (EBT).

Original languageEnglish (US)
Pages (from-to)253-263
Number of pages11
JournalAltex
Volume27
Issue number4
StatePublished - 2010

Fingerprint

Toxicology
Evidence-Based Medicine
Validation Studies
Clinical Medicine
Multicenter Studies
Meta-Analysis
Prospective Studies
Guidelines

Keywords

  • Alternative methods
  • Cell culture
  • Evidence-based medicine
  • Genomics
  • Quality assurance

ASJC Scopus subject areas

  • Medical Laboratory Technology
  • Pharmacology
  • Medicine(all)

Cite this

Evidence-Based Toxicology - The Toolbox of Validation for the 21 st Century? / Hartung, Thomas.

In: Altex, Vol. 27, No. 4, 2010, p. 253-263.

Research output: Contribution to journalArticle

@article{848d7ae7f15e46b8a108578bb79396de,
title = "Evidence-Based Toxicology - The Toolbox of Validation for the 21 st Century?",
abstract = "Validation has become a primary driver of the evolution of toxicological methods. Agreement at OECD level currently requires validation of new approaches for consideration in test guideline development. Several examples of this exist. However, the toxicology in the 21st century movement, prompted by the 2007 NRC/NAS vision document, might lead to a revolutionary change in the toxicological toolbox. The challenge is whether the validation process, as it has been formalized over the last two decades, meets the needs for this paradigm shift. The concept of evidence-based medicine (EBM) has emerged from clinical medicine, which retrospectively assesses the evidence of adequacy of a given approach. This is not typically done in prospective studies - the equivalent of validation studies might be multicenter randomized trials. Evidently, where such unambiguous evidence is available, no other assessment is necessary. EBM, however, has developed procedures, including meta-analysis, to collect and evaluate all the available evidence where no such definitive study is available. The recent successful introduction of retrospective validation, i.e. the collection and evaluation of existing evidence from various sources, represents a step in this direction. Here, we will explore new toxicological approaches via evidence-based toxicology (EBT).",
keywords = "Alternative methods, Cell culture, Evidence-based medicine, Genomics, Quality assurance",
author = "Thomas Hartung",
year = "2010",
language = "English (US)",
volume = "27",
pages = "253--263",
journal = "ALTEX : Alternativen zu Tierexperimenten",
issn = "1868-596X",
publisher = "Elsevier GmbH",
number = "4",

}

TY - JOUR

T1 - Evidence-Based Toxicology - The Toolbox of Validation for the 21 st Century?

AU - Hartung, Thomas

PY - 2010

Y1 - 2010

N2 - Validation has become a primary driver of the evolution of toxicological methods. Agreement at OECD level currently requires validation of new approaches for consideration in test guideline development. Several examples of this exist. However, the toxicology in the 21st century movement, prompted by the 2007 NRC/NAS vision document, might lead to a revolutionary change in the toxicological toolbox. The challenge is whether the validation process, as it has been formalized over the last two decades, meets the needs for this paradigm shift. The concept of evidence-based medicine (EBM) has emerged from clinical medicine, which retrospectively assesses the evidence of adequacy of a given approach. This is not typically done in prospective studies - the equivalent of validation studies might be multicenter randomized trials. Evidently, where such unambiguous evidence is available, no other assessment is necessary. EBM, however, has developed procedures, including meta-analysis, to collect and evaluate all the available evidence where no such definitive study is available. The recent successful introduction of retrospective validation, i.e. the collection and evaluation of existing evidence from various sources, represents a step in this direction. Here, we will explore new toxicological approaches via evidence-based toxicology (EBT).

AB - Validation has become a primary driver of the evolution of toxicological methods. Agreement at OECD level currently requires validation of new approaches for consideration in test guideline development. Several examples of this exist. However, the toxicology in the 21st century movement, prompted by the 2007 NRC/NAS vision document, might lead to a revolutionary change in the toxicological toolbox. The challenge is whether the validation process, as it has been formalized over the last two decades, meets the needs for this paradigm shift. The concept of evidence-based medicine (EBM) has emerged from clinical medicine, which retrospectively assesses the evidence of adequacy of a given approach. This is not typically done in prospective studies - the equivalent of validation studies might be multicenter randomized trials. Evidently, where such unambiguous evidence is available, no other assessment is necessary. EBM, however, has developed procedures, including meta-analysis, to collect and evaluate all the available evidence where no such definitive study is available. The recent successful introduction of retrospective validation, i.e. the collection and evaluation of existing evidence from various sources, represents a step in this direction. Here, we will explore new toxicological approaches via evidence-based toxicology (EBT).

KW - Alternative methods

KW - Cell culture

KW - Evidence-based medicine

KW - Genomics

KW - Quality assurance

UR - http://www.scopus.com/inward/record.url?scp=79952311389&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79952311389&partnerID=8YFLogxK

M3 - Article

C2 - 21240468

AN - SCOPUS:79952311389

VL - 27

SP - 253

EP - 263

JO - ALTEX : Alternativen zu Tierexperimenten

JF - ALTEX : Alternativen zu Tierexperimenten

SN - 1868-596X

IS - 4

ER -