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This review discusses issues in using animals to predict human toxicity in pharmaceutical development. Part 1 focuses on scientific concerns over the validity of animal research. Part 2 will discuss alternatives to animal research and their validation and use in production of human pharmaceuticals.
Increasingly, toxicologic testing in animals and preclinical animal studies in drug development have been questioned because of poor correlation with in-human results (1).
4 sty 2017 · Widespread public and scientific interest in promoting the care and well-being of animals used for toxicity testing has given rise to improvements in animal welfare practices and views over time, as well as laws and regulations that support means to reduce, refine, and replace animal use (known as the 3Rs) in certain toxicity studies.
1 wrz 2023 · Alternatives to animal testing are emerging across of variety of sectors that require toxicity testing. Alternatives to animal testing were pioneered by the cosmetics industry, but their use in food safety testing is limited.
Toxicity testing in animals is conducted to identify possible adverse effects resulting from exposure to an agent and to develop dose-response relationships that allow evaluation of responses at other exposures. Toxicity tests are designed to minimize variance, bias, and the potential for false-positive and false-negative results.
24 lis 2020 · Toxicity assessments in animals form an integral part of the drug development process, providing data to support the design of human clinical trials and the safety of participating volunteers and patients.
17 gru 2019 · Animal toxicity tests are phenotypic “apical” tests—complex experiments that measure integrated biological endpoints, each of which is an integrated measure of multiple facets of the machinery necessary for in vivo function.
