T/CALAS 81-2020 Active Group standards

T/CALAS 81-2020 Quality specifications for genetically modified animal models used in potential carcinogenicity evaluation

Publish Date: 2020-12-01 Implement Date: 2021-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CALAS 81-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Animal husbandry and breeding

Publish Date: 2020-12-01

Implement Date: 2021-01-01

Scope

Scope: This document specifies the quality control requirements for genetically modified animal models used in the preclinical evaluation of the potential carcinogenicity of drugs, medical devices, and other test substances, including the technical requirements for model preparation, model biological characteristics, model background data, and sensitivity verification. This document is applicable to animal production and supply institutions for reference when controlling model quality, or for conducting short-term carcinogenicity evaluation experiments based on animal models in accordance with the ICH S1B Guidelines for Carcinogenicity Studies. It can also be used as a reference for GLP (Good Laboratory Practice for Preclinical Safety Evaluation of Drugs) institutions and CROs (contract research organizations) when selecting animal models; and it can also serve as a reference for regulatory authorities to evaluate whether the model selection is appropriate. Main technical contents: Establishment of genetically modified animal models, genotype identification and biological characteristics analysis, model resource preservation, background parameter requirements for carcinogenicity genetically modified animal models, genetic stability testing, animal model production systems, and microbiological grade control of animal models.