DOPATREE
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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
CLINICAL PHARMACOLOGY STUDIES (CP STUDIES, STUDY, HUMAN PHARMACOLOGY, DATA STUDIES)
CLINICAL PHARMACOLOGY STUDIES / TYPES
HEPATIC IMPAIRMENT STUDY (IMPAIRED LIVER STUDIES)
HEPATIC IMPAIRMENT STUDY / TYPES
Parents
HEPATIC IMPAIRMENT STUDY (IMPAIRED LIVER STUDIES)
Children
FULL STUDY (SINGLE DOSE TO NORMAL, CHILD-PUGH CLASS A MILD, CHILD-PUGH CLASS B MODERATE, CHILD-PUGH CLASS C SEERE)
POPULATION-PK (IF DRUG METABOLIZED BY ENZYME WITH GENETIC POLYMORPHISMS, SELECT BY GENOTYPE STATUS)
REDUCED STUDY (NORMAL VS. CHILD-PUGH B MODERATE)