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FDA regulatory guidance
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
Sponsors usually must conduct PD studies, such as in vitro binding assays and in vivo studies that assess the product’s pharmacological activity and define its mechanism of action (MOA). Biologics typically undergo single- and repeat-dose toxicity studies using relevant species, as noted earlier. Safety pharmacology studies, which evaluate the product’s functional effects on major body systems and specific organs, and local tolerance testing can be done separately or subsumed in toxicity testing.
Evaluation of in vitro cytotoxicity and in vivo potential toxicity of the extract from in vitro cultivated Anoectochilus roxburghii Lindl
Published in Journal of Toxicology and Environmental Health, Part A, 2021
Doan Chinh Chung, Thanh Long Le, Nguyen Quynh Chi Ho, Thi Thuy Nguyen, Dang Giap Do, Duc Thang Do, Thi Phuong Mai Nguyen, Thi Phuong Thao Nguyen, Nghia Son Hoang
According to the guidelines for safety pharmacology evaluation of natural products or drugs (CFDA 2007), Sprague Dawley rats of both genders were used in both acute and subchronic oral toxicity tests to assess the safety of iARE. Data demonstrated that iARE did not produce any apparent acute or sub-chronic toxicity. In the acute oral toxicity study, a single dose of iARE at 1000 or 5000 mg/kg produced no mortality and no signs of toxicity within 14 days. According to OECD 407 (2008), iARE may thus be considered safe for rats even at the highest dose of 5000 mg/kg (LD50 > 5000 mg/kg). These results are in agreement with the study of Liu et al. (2020) who found that the LD50 of A. roxburghii crude extract in rats was estimated to be greater than 5000 mg/kg. Similarly, Lin et al. (2000) also indicated that A. formosanus had a value of LD50 above 5000 mg/kg in rats.