The development of advanced alternative testing methods has led to approaches that use no animals in the pharmaceutical development process. (Ministry of Trade, Industry and Energy)
By Jeon Misun
A government initiative is developing advanced alternative testing methods that use no animals in the pharmaceutical development process.
In a joint project with the Ministry of Science and ICT and the Ministry of Health and Welfare to be launched this year, the Ministry of Trade, Industry and Energy on June 27 announced a performance dissemination council for nonclinical efficacy evaluation technology and product development for advanced biopharmaceuticals.
The new methods are expected to resolve ethical issues arising from nonclinical animal testing, which used to be key to new drug development, and raise accuracy in predicting human biological responses to new drug candidates.
In the drug development process, nonclinical animal testing saw drug candidates injected into animals to assess toxicity and efficacy. This approach, however, raised bioethical concerns and often led to clinical failure because of the fundamental biological differences between animals and humans.
This project seeks to support the development of full-cycle technologies including the setup of a microphysiological system that can be tested under human-like conditions; development of source technologies for verification; creation of systems and assessment methods with a high degree of human likeness; and localization of materials, components, software and analytical equipment for nonclinical evaluation platforms.
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