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DOPATREE
UNITED STATES GOVERNMENT ORGANIZATIONS / LISTINGS
US FOOD AND DRUG ADMINISTRATION (FDA)
DRUGS AND BIOLOGICS / RELATED / US
DRUG SAFETY AND BIOLOGIC SAFETY (PHARMACOVIGILANCE, PV, CLINICAL, POSTMARKETING, SERIOUS ADVERSE EVENT, SAE, IND, 7-DAY, 15-DAY, EXPEDITED, SIDE EFFECTS, ICSR, PSUR, LITERATURE, SURVEILLANCE, E2B, SAFETY REPORTING, DATA, MEDICATION)
DRUG SAFETY AND BIOLOGIC SAFETY / RELATED / INTL
TREATMENT-RELATED CONDITIONS-ALL (DRUG-RELATED, BIOLOGIC-RELATED, DEVICE-RELATED, TREATMENT EMERGENT ADVERSE EVENTS, TEAE, ADVERSE DRUG REACTIONS, SIDE EFFECTS, ALL TOXICITIES, TOXICITY, PRODUCT-RELATED, DRUG-INDUCED)
TREATMENT-RELATED CONDITIONS / LISTINGS
CARCINOGENICITY STUDY (CARCINOGEN EXPOSURE, CANCER-CAUSING, IMPURITIES, STUDIES)
CARCINOGENICITY STUDY / LAWS AND REGULATIONS / US
Parents
CARCINOGENICITY STUDY (CARCINOGEN EXPOSURE, CANCER-CAUSING, IMPURITIES, STUDIES)
Children
US FDA. DRAFT GUIDANCE. STATISTICAL ASPECTS OF THE DESIGN, ANALYSIS, AND INTERPRETATION OF CHRONIC RODENT CARCINOGENICITY STUDIES OF PHARMACEUTICALS. MAY 08, 2001.
US FDA. GUIDANCE. CARCINOGENICITY STUDY PROTOCOL SUBMISSIONS. MAY 23, 2002.
US FDA. GUIDANCE. CVM GFI #141 (VICH GL28) STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: CARCINOGENICITY TESTING. JUL 27, 2006.
US FDA. GUIDANCE. M7 ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK - QUESTIONS AND ANSWERS. JUN 29, 2020.
US FDA. GUIDANCE. M7(R1) ADDENDUM TO ICH M7 : ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK. SEP 2015.
US FDA. GUIDANCE. M7(R1) ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK. MAR 2018.
US FDA. GUIDANCE. M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES. APR 2022.
US FDA. GUIDANCE. REDBOOK 2000 : IV.C.6. CARCINOGENICITY STUDIES WITH RODENTS. JAN 2006.
US FDA. GUIDANCE. S1A THE NEED FOR LONG-TERM RODENT CARCINOGENICITY STUDIES OF PHARMACEUTICALS. MAR 01, 1996.
US FDA. GUIDANCE. S1B TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS. FEB 23, 1998.
US FDA. GUIDANCE. S1B(R1) ADDENDUM TO S1B TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS. NOV 2022.
US FDA. GUIDANCE. S1C(R2) DOSE SELECTION FOR CARCINOGENICITY STUDIES. SEP 2008. REV. 1.