What nonclinical toxicology studies are recommended for the development of biotechnology-derived pharmaceuticals?

刊登日期:2019-11-12  |  點閱次數 : 368 次 

General toxicology, safety pharmacology, and immunogenicity assessments should be considered for the biotechnology-derived products. Functional indices of safety pharmacology may be investigated in separate studies or incorporated in the design of toxicity studies. The need for reproductive/developmental toxicity studies is dependent upon the product, clinical indication and intended patient population. Standard carcinogenicity bioassays are generally inappropriate for biotechnology-derived products. However, product-specific assessment of carcinogenic potential may still be needed depending upon duration of clinical dosing, patient population and/or biological activity of the product (e.g., growth factors, immunosuppressive agents, etc.). When there is a concern about carcinogenic potential, a variety of approaches may be considered to evaluate risk. In general, the routinely genotoxicity studies are not needed for biotechnology-derived products. Appropriate nonclinical safety studies should be determined in accordance with ICH S6(R1)「Preclinical safety evaluation of biotechnology-derived pharmaceuticals」and 「藥品非臨床試驗安全性規範」-第四章生物藥品之非臨床試驗規範。



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