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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...
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...
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...

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Related Experiment Video

Updated: Jun 24, 2026

Long-term Lethal Toxicity Test with the Crustacean Artemia franciscana
14:40

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Published on: April 14, 2012

Developmental and reproductive toxicity studies on artemisone.

G Schmuck1, A-M Klaus, F Krötlinger

  • 1Bayer Healthcare AG, Pharma Research Center, Wuppertal, Germany. Gabriele.Schmuck@bayerhealthcare.com

Birth Defects Research. Part B, Developmental and Reproductive Toxicology
|March 24, 2009
PubMed
Summary

Artemisone, a new artemisinin derivative, showed embryo- and fetotoxicity in animal studies. Reproductive and developmental effects were only observed at severe toxicity levels, indicating potential risks during pregnancy.

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Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants
07:08

Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants

Published on: March 6, 2018

Area of Science:

  • Reproductive toxicology
  • Developmental toxicology
  • Pharmacology

Background:

  • Artemisone is a novel artemisinin derivative.
  • Clinical studies in women of child-bearing age require safety data.
  • Preclinical studies assessed fertility, embryonic development, and toxicity.

Purpose of the Study:

  • To evaluate the reproductive and developmental safety of artemisone.
  • To determine dose-dependent effects on fertility, embryonic development, and offspring health.
  • To establish safe dosage limits for potential human trials.

Main Methods:

  • Fertility and early embryonic development study in rats.
  • Developmental toxicity studies in rats and rabbits.
  • Peri- and postnatal developmental toxicity study in rats.

Main Results:

  • Artemisone induced embryo- and fetotoxicity at maternally toxic doses.
  • Rats were more sensitive than rabbits; total litter loss occurred at 2 mg/kg in rats.
  • Cardiac defects and ossification delays were observed at high doses in rabbits and rats, respectively.

Conclusions:

  • Artemisone is embryo- and fetotoxic, causing cardiac defects and ossification delays at doses inducing abortions and litter loss.
  • No adverse reproductive or developmental effects were noted below severe toxicity levels.
  • Findings necessitate careful consideration for use in women of child-bearing age.