CDE Incorporates Organoid Models into Guidelines
2025-03-10
On October 10, 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration released the "Notice on Soliciting Opinions on the Technical Guidelines for Model - Guided R & D of Rare Disease Drugs (Draft for Comment)". The draft clearly states that due to the particularity nature of rare diseases, non - clinical research data in the R & D of rare disease drugs include, but are not limited to, gene, molecular, cell, organoid, organ - on - a - chip, and animal research data. It also emphasizes that the basis for dose selection in clinical research can be derived from animal research and /or in - vitro research results such as organoids and molecules.Jiyan Biotech positions itself in the field of precision oncology medical services. It focuses on the construction of tumor organoid models and the development of organ - on - a - chip technology platforms, which are applied to drug sensitivity testing, drug evaluation, research on potential targe...
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