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In Vivo Preclinical Toxicity Test Guidelines
Local Title:
NOMOR … TAHUN ... TENTANG PEDOMAN UJI TOKSISITAS PRAKLINIK SECARA IN VIVO
Country/Region:
Indonesia
Competent Authority:
Badan Pengawas Obat dan Makanan
Type:
Regulation
Status:
Draft
Release Date:
2020-11-30
Implementation Date:
/
Document
Language Source Title Access
ID
Official In Vivo Preclinical Toxicity Test Guidelines
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In Vivo Preclinical Toxicity Test Guidelines
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Summary

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.

Noteworthy Information