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DOPATREE
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
IMMUNOGENICITY (ANTI-DRUG ANTIBODIES, ADA, IMMUNOGENECITY, IMMUNOTOXICITY, IMMUNOTOXIC POTENTIAL, TESTING)
IMMUNOGENICITY / RELATED
IMMUNOGENICITY STUDY (BIOLOGICS ONLY)
IMMUNOGENICITY STUDY / LAWS AND REGULATIONS / US
Parents
IMMUNOGENICITY STUDY (BIOLOGICS ONLY)
Children
ICH. SAFETY GUIDELINES. ACCESSED : JUN 13, 2022. (S1-CARCINOGENICITY STUDIES, S2-GENOTOXICITY STUDIES, S3-TOXICOKINETICS AND PHARMACOKINETICS, S4-TOXICITY TESTING, S5-REPRODUCTIVE TOXICOLOGY, S6-BIOTECHNOLOGICAL PRODUCTS, S7-PHARMACOLOGY STUDIES, S8-IMMUNOTOXICOLOGY STUDIES, S9-NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS, S10-PHOTOSAFETY EVALUATION, S11-NONCLINICAL PAEDIATRIC SAFETY, S12-NON-CLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS)
US FDA. DRAFT GUIDANCE. CLINICAL IMMUNOGENICITY CONSIDERATIONS FOR BIOSIMILAR AND INTERCHANGEABLE INSULIN PRODUCTS. NOV 2019.
US FDA. DRAFT GUIDANCE. IMMUNOGENICITY INFORMATION IN HUMAN PRESCRIPTION THERAPEUTIC PROTEIN AND SELECT DRUG PRODUCT LABELING - CONTENT AND FORMAT. FEB 2022.
US FDA. DRAFT GUIDANCE. NONCLINICAL SAFETY EVALUATION OF THE IMMUNOTOXIC POTENTIAL OF DRUGS AND BIOLOGICS. FEB 2020.
US FDA. GUIDANCE. IMMUNOGENICITY ASSESSMENT FOR THERAPEUTIC PROTEIN PRODUCTS. AUG 2014.
US FDA. GUIDANCE. IMMUNOGENICITY TESTING OF THERAPEUTIC PROTEIN PRODUCTS - DEVELOPING AND VALIDATING ASSAYS FOR ANTI-DRUG ANTIBODY DETECTION. JAN 2019.
US FDA. GUIDANCE. IMMUNOGENICITY-RELATED CONSIDERATIONS FOR LOW MOLECULAR WEIGHT HEPARIN. FEB 2016.
US FDA. GUIDANCE. IMMUNOTOXICITY TESTING GUIDANCE. MAY 05, 1999.
US FDA. GUIDANCE. IMMUNOTOXICOLOGY EVALUATION OF INVESTIGATIONAL NEW DRUGS. NOV 01, 2002.
US FDA. GUIDANCE. S8 IMMUNOTOXICITY STUDIES FOR HUMAN PHARMACEUTICALS. APR 12, 2006.