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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...
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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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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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...
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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...
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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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Historical control data in reproductive and developmental toxicity studies.

Eve Mylchreest1, Stephen B Harris

  • 1Southern Research, Birmingham, AL, USA. mylchreest@southernresearch.org

Methods in Molecular Biology (Clifton, N.J.)
|November 10, 2012
PubMed
Summary

Historical control data enhances the interpretation of reproductive and developmental toxicity studies by providing a broader context for rare events like fetal malformations. This approach improves risk assessment for pharmaceuticals and chemicals.

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Area of Science:

  • Toxicology
  • Reproductive toxicology
  • Developmental toxicology

Background:

  • Reproductive and developmental toxicity studies assess risks of pharmaceuticals and chemicals.
  • Concurrent control groups are standard but have limitations, especially for rare events like fetal malformations.
  • Differences between groups can occur by chance, potentially mimicking dose-related effects.

Purpose of the Study:

  • To provide guidance on building and applying a historical control database for interpreting reproductive and developmental toxicity data.
  • To highlight the utility of historical control data for understanding biological variability and laboratory performance.
  • To demonstrate the application of historical control data using supernumerary rib as an example.

Main Methods:

  • Utilizing historical control data alongside concurrent control groups for comparative analysis.
  • Establishing a laboratory historical control database.
  • Applying descriptive statistics for data presentation and interpretation.
  • Analyzing rare events, such as fetal malformations, against a larger control dataset.

Main Results:

  • Historical control data aids in understanding the range of normal biological variation for specific endpoints.
  • It helps monitor long-term biological variability influenced by external factors.
  • It enables tracking of laboratory performance and identification of internal factor-related data changes.

Conclusions:

  • Historical control data is crucial for robust interpretation of reproductive and developmental toxicity studies, especially for rare adverse events.
  • It provides a valuable benchmark for assessing the significance of findings from concurrent control groups.
  • Implementing historical control data improves the scientific rigor and reliability of toxicity risk assessments.