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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...
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...
Toxic Reactions: Overview01:26

Toxic Reactions: Overview

When toxic substances penetrate the human body, they disseminate to various tissues, undergoing metabolic changes. This process yields reactive metabolites that may covalently bind with specific target molecules, resulting in toxicity.
Toxicity falls into two primary categories: local and systemic.
Local toxicity appears at the exposure site, such as protein denaturation caused by caustic substances.
In contrast, systemic toxicity requires the toxic agent's absorption and distribution,...
Types of Toxins01:36

Types of Toxins

Humans continually engage with an environment rich in potentially harmful chemicals. These are introduced to our bodies through inhalation, ingestion, or skin contact. These chemicals exist in various forms, such as air and environmental pollutants, agricultural chemicals, organic solvents, and heavy metals.
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Environmental pollutants like...
Enhanced Elimination of Poison01:26

Enhanced Elimination of Poison

Poison can be effectively removed from the gastrointestinal (GI) tract through various decontamination procedures.
Antidotes serve a crucial role in counteracting the effects of poison by inhibiting enzymes responsible for producing harmful drug metabolites. In some cases, these toxic metabolites can be neutralized by endogenous cosubstrates, which are maintained at specific concentrations to prevent interaction with cellular macromolecules and subsequent cell death.
Renal excretion is the...
Drug Toxicity: Dose-Dependent Reactions01:24

Drug Toxicity: Dose-Dependent Reactions

Drug toxicities can be stratified into pharmacological, pathological, or genotoxic based on their mechanisms. The incidence and severity of these toxicities generally increase with the drug's concentration in the body and exposure time.Pharmacological toxicity is evident when the therapeutic effects of drugs overshoot into adverse reactions in a predictable, dose-dependent manner. Central nervous system (CNS) depression from barbiturates is a classic example, with effects escalating from...

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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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Published on: June 17, 2015

From alternative methods to a new toxicology.

Thomas Hartung1

  • 1Dept Environmental Health Sciences, Johns Hopkins University, Baltimore, MD 21205, USA. THartung@jhsph.edu

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
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PubMed
Summary

Mechanistic toxicology is advancing with new methods that complement animal testing. Evidence-based toxicology (EBT) and systematic reviews are crucial for integrating these approaches into regulatory safety assessments.

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Area of Science:

  • Toxicology
  • Regulatory Science
  • Biotechnology

Background:

  • Mechanistic toxicology increasingly uses non-animal testing methods driven by biotechnology and informatics.
  • Regulatory toxicology adoption of these new approaches has been slow despite validation efforts.
  • Regulatory pressures in the EU (REACH, cosmetics legislation) and US (NRC vision report) necessitate new toxicological strategies.

Purpose of the Study:

  • To advocate for the integration of new methodologies into regulatory toxicology.
  • To highlight the need for evidence-based toxicology (EBT) for objective assessment.
  • To propose a new regulatory toxicology framework based on toxicity pathways and data analysis.

Main Methods:

  • Review of validation efforts for alternative toxicological methods.
  • Analysis of regulatory drivers for adopting new approaches (e.g., EU legislation, US EPA strategy).
  • Conceptualization of evidence-based toxicology (EBT) principles.

Main Results:

  • Validation studies confirm that new approaches do not compromise safety standards.
  • New approaches, including human cell cultures, high-throughput testing, and modeling, are feasible.
  • Evidence-based toxicology (EBT) offers a framework for rigorous assessment of toxicological data.

Conclusions:

  • A new approach to regulatory toxicology is needed, centered on identified toxicity pathways.
  • Evidence-based toxicology (EBT), modeled on evidence-based medicine, can guide this transition.
  • Systematic reviews and quantitative meta-analyses are key tools for advancing regulatory toxicology.