DOPATREE
Preview
Open in TheBrain
DOPATREE
EMA PHARMACOVIGILANCE PLANS / RELATED
EMA PHARMACOVIGILANCE ACTIVITIES
EMA PHARMACOVIGILANCE ACTIVITIES / LISTINGS / ADDITIONAL
CLINICAL STUDIES-ALL (CLINICAL TRIALS, STUDY, PROTOCOLS, MASTER PROTOCOLS, CLINICAL OPERATIONS, CLINICAL STUDY DESIGNS, COVARIATES, CONTINUOUS OUTCOMES, ICH E8, ENRICHMENT, STUDY REPORT, HOLD, CLINICAL INVESTIGATIONS)
CLINICAL STUDIES / TYPES
EARLY-PHASE CLINICAL STUDY (PHARMACOKINETIC, PK/PD, PK-PD, NORMAL HEALTHY, FEED AND BLEED, EARLY STAGE, ES, PHASE IA, IB, 1, BA/BE, ASCENDING, SAD, MAD, DRUG-DRUG, POPULATION PK, DOSE-RESPONSE, FIH)
EARLY-PHASE CLINICAL STUDY / TYPES
FIRST-IN-HUMAN STUDY (FIH STUDIES, FIRST IN HUMAN, STARTING HUMAN DOSE, HUMAN MICRODOSE STUDIES, PHASE 0)
FIRST-IN-HUMAN STUDY / LAWS AND REGULATIONS / US
Parents
FIRST-IN-HUMAN STUDY (FIH STUDIES, FIRST IN HUMAN, STARTING HUMAN DOSE, HUMAN MICRODOSE STUDIES, PHASE 0)
Children
US FDA. GUIDANCE. ESTIMATING THE MAXIMUM SAFE STARTING DOSE IN INITIAL CLINICAL TRIALS FOR THERAPEUTICS IN ADULT HEALTHY VOLUNTEERS. JUL 28, 2005.
US FDA. GUIDANCE. EXPANSION COHORTS : USE IN FIRST-IN-HUMAN CLINICAL TRIALS TO EXPEDITE DEVELOPMENT OF ONCOLOGY DRUGS AND BIOLOGICS. MAR 2022.
US FDA. GUIDANCE. INVESTIGATIONAL DEVICE EXEMPTIONS (IDES) FOR EARLY FEASIBILITY MEDIAL DEVICE CLINICAL STUDIES, INCLUDING CERTAIN FIRST IN HUMAN (FIH) STUDIES. OCT 1, 2013.