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On Nov. 30, 2020, Indonesia BPOM released te draft In Vivo Preclinical Toxicity Test Guidelines for public consultation.
In Vivo Preclinical Toxicity Test is a test performed on test animals to detect toxic effects on biological systems and to obtain typical dose-response data from test preparations.
In Vivo Preclinical Toxicity Test Guidelines include:
a. oral acute toxicity test;
b. oral sub-chronic toxicity test;
c. oral chronic toxicity test;
d. teratogenicity test;
e. skin sensitization test;
f. eye irritation test;
g. acute dermal irritation/corrosion test;
h. vaginal mucosal irritation test;
i. acute dermal toxicity test;
j. sub-chronic dermal toxicity test; and
k. carcinogenicity toxicity test.
