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Related Concept Videos

Toxicity Testing in Animals01:23

Toxicity Testing in Animals

Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
Mutagenicity and Carcinogenicity01:25

Mutagenicity and Carcinogenicity

Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Teratogenicity01:07

Teratogenicity

The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
In vitro Mutagenesis01:16

In vitro Mutagenesis

To learn more about the function of a gene, researchers can observe what happens when the gene is inactivated or “knocked out,” by creating genetically engineered knockout animals. Knockout mice have been particularly useful as models for human diseases such as cancer, Parkinson’s disease, and diabetes.
Toxicokinetics: Overview01:21

Toxicokinetics: Overview

Studies that assess how a drug is absorbed, distributed, metabolized, and excreted (ADME) at toxic doses are termed toxicokinetics. Understanding toxicokinetics helps predict adverse drug reactions (ADRs) and manage toxicity in humans.Toxicokinetics differs from pharmacokinetics mainly in the dose levels studied, with toxicokinetics focusing on higher toxic doses. The kinetics at these levels can be non-linear due to altered physiological processes. Toxicodynamics examines the relationship...

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Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
17:28

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Published on: June 17, 2015

The way forward in reproductive/developmental toxicity testing.

Horst Spielmann1

  • 1Faculty of Biology, Chemistry and Pharmacy, Freie Universität Berlin, Berlin, Germany. Horst.Spielmann@fu-berlin.de

Alternatives to Laboratory Animals : ATLA
|January 29, 2010
PubMed
Summary
This summary is machine-generated.

Reducing animal testing in reproductive toxicity is crucial. Advanced in vitro methods like the embryonic stem cell test show promise, alongside refined in vivo studies, to meet regulatory demands.

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Rapid Evaluation of Toxicity of Chemical Compounds Using Zebrafish Embryos
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Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
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Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
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Rapid Evaluation of Toxicity of Chemical Compounds Using Zebrafish Embryos
07:49

Rapid Evaluation of Toxicity of Chemical Compounds Using Zebrafish Embryos

Published on: August 25, 2019

Area of Science:

  • Reproductive toxicology
  • In vitro and in vivo testing methodologies
  • Chemical safety assessment

Background:

  • The EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) system may increase animal testing for reproductive toxicity.
  • Current testing strategies for drugs, agrochemicals, and industrial chemicals differ significantly due to historical reasons.
  • The 50th anniversary of the Three Rs concept (Replacement, Reduction, Refinement) prompts a review of animal use in reproductive toxicity testing.

Purpose of the Study:

  • To critically review the use of experimental animals in reproductive toxicity testing.
  • To evaluate the current status and validation of in vitro tests for reproductive toxicology.
  • To propose strategies for reducing animal use in reproductive toxicity testing under regulatory frameworks like REACH.

Main Methods:

  • Comparison of existing test guidelines for drugs, agrochemicals, and industrial chemicals.
  • Critical evaluation of the development and validation of in vitro tests, including the mouse embryonic stem cell test (mEST) and human embryonic stem cell test (hEST).
  • Overview of new in vitro tests being developed in the ReProTect project.
  • Discussion of opportunities for refining standard in vivo tests.

Main Results:

  • The mouse embryonic stem cell test (mEST) is the most advanced in vitro test, with established use in preclinical drug development and promising molecular endpoints.
  • The ReProTect project's test battery shows potential as a screening assay for reproductive toxicity under EU REACH.
  • Refinement of standard in vivo tests, such as the 'extended one-generation reproductive toxicity study' (EOGRTS), can significantly reduce animal numbers.
  • Validated in vitro methods are not yet available for short-term regulatory use.

Conclusions:

  • In vitro methods, including the ReProTect battery and embryonic stem cell (ESC) technology, hold significant promise for 21st-century reproductive toxicity testing.
  • Harmonization of test methods across regulatory areas is a necessary first step.
  • A shift towards exposure-driven testing for industrial chemicals, incorporating advanced studies like EOGRTS, is recommended to reduce animal use.
  • Continued development and validation of in vitro assays are essential for future regulatory acceptance.