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UNDERSTANDING OF CHEMICAL CARCINOGENESIS: CURRENT AND FUTURE PERSPECTIVES Carcinogenesis refers to the process by which a normal cell is transformed into a malignant cell and repeatedly divides to become a cancer Chemicals which initiate this process is called chemical carcinogens Chemicals which increase the effectiveness of carcinogens is called co-carcinogens CLASSIFICATION OF CHEMICAL CARCINOGENS MECHANISM OF ACTION STAGES OF CARCINOGENESIS ROLE OF PROTO-ONCOGENES AND TUMOR SUPPRESSOR GENES ACTIVATION OF PROTO ONCOGENES INACTIVATION OF TUMOR SUPPRESSOR GENE OXIDATIVE STRESS IN CARCINOGENESIS ROS can be produced from both endogenous and exogenous sources Attack both purine and pyrimidine bases, as well as the deoxyribose backbone Induces DNA damage which includes single or double-strand breakage, deoxyribose modification, and DNA cross-link If DNA damage is not properly repaired it may result in mutation which leads to cancer BIOMARKERS REGULATORY BACKGROUND OECD guidelines 451- Carcinogenecity studies 453- Combined chronic toxicity/carcinogenecity ICH guidelines S1A- Guideline on the need for carcinogenicity studies of pharmaceuticals S1B- Testing for carcinogenicity of pharmaceuticals S1C- Dose selection for carcinogenicity studies of pharmaceuticals
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UNDERSTANDING OF CHEMICAL CARCINOGENESIS: CURRENT AND FUTURE PERSPECTIVES Carcinogenesis refers to the process by which a normal cell is transformed into a malignant cell and repeatedly divides to become a cancer Chemicals which initiate this process is called chemical carcinogens Chemicals which increase the effectiveness of carcinogens is called co-carcinogens CLASSIFICATION OF CHEMICAL CARCINOGENS MECHANISM OF ACTION STAGES OF CARCINOGENESIS ROLE OF PROTO-ONCOGENES AND TUMOR SUPPRESSOR GENES ACTIVATION OF PROTO ONCOGENES INACTIVATION OF TUMOR SUPPRESSOR GENE OXIDATIVE STRESS IN CARCINOGENESIS ROS can be produced from both endogenous and exogenous sources Attack both purine and pyrimidine bases, as well as the deoxyribose backbone Induces DNA damage which includes single or double-strand breakage, deoxyribose modification, and DNA cross-link If DNA damage is not properly repaired it may result in mutation which leads to cancer BIOMARKERS REGULATORY BACKGROUND OECD guidelines 451- Carcinogenecity studies 453- Combined chronic toxicity/carcinogenecity ICH guidelines S1A- Guideline on the need for carcinogenicity studies of pharmaceuticals S1B- Testing for carcinogenicity of pharmaceuticals S1C- Dose selection for carcinogenicity studies of pharmaceuticals
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