Ethical considerations in conducting pediatric and neonatal research in clinical pharmacology

Current Pharmaceutical Design

Volumn 21, Issue 39, 2015, Pages 5619-5635

  Roth Cline, Michelle ^a   Nelson, Robert M ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Child assent; Children; Clinical research; Ethics; Neonates; Parental permission; Pediatrics; Subpart D

Indexed keywords

ANALGESIC AGENT; CLOPIDOGREL; DEXAMPHETAMINE; HEMATOLOGIC AGENT; HEMOGLOBIN;

ADVISORY COMMITTEE; ANALYTIC METHOD; ARTICLE; ATTENTION DEFICIT DISORDER; BIOETHICS; BLOOD VOLUME; CHILD; CHILD PROTECTION; CHILD SAFETY; CHILDHOOD CANCER; CLINICAL PHARMACOLOGY; CLINICAL RESEARCH; COMPONENT ANALYSIS; CONCEPTUAL FRAMEWORK; CONGENITAL HEART DISEASE; CONSENSUS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG INDICATION; DRUG METABOLISM; EQUIPOISE; FIRST IN HUMAN STUDY; FOOD AND DRUG ADMINISTRATION; GESTATIONAL AGE; GOOD CLINICAL PRACTICE; HEALTH HAZARD; HEMOGLOBIN BLOOD LEVEL; HUMAN; INFORMED CONSENT; INTESTINE MOTILITY; LICENSING; MINOR (PERSON); NEWBORN; NONALCOHOLIC FATTY LIVER; NONHUMAN; OFF LABEL DRUG USE; PATENT; PATIENT PARTICIPATION; PEDIATRICS; PERINATAL DEVELOPMENT; PHASE 1 CLINICAL TRIAL (TOPIC); PHYSICAL EXAMINATION; PRACTICE GUIDELINE; PREMATURITY; PRESCRIPTION; PRIORITY JOURNAL; PSYCHOLOGIC TEST; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH SUBJECT; RISK BENEFIT ANALYSIS; SHUNT THROMBOSIS; STANDARD; STOMACH EMPTYING; STOMACH PH; SYSTEMIC PULMONARY SHUNT; THROMBOCYTE AGGREGATION; UNLICENSED DRUG USE; VERY LOW BIRTH WEIGHT; VULNERABLE POPULATION; CLINICAL TRIAL (TOPIC); DRUG THERAPY; MEDICAL RESEARCH; PHARMACOLOGY;

BIOMEDICAL RESEARCH; CHILD; CLINICAL TRIALS AS TOPIC; DRUG THERAPY; HUMANS; INFANT, NEWBORN; PHARMACOLOGY;

EID: 84954247418     PISSN: 13816128     EISSN: 18734286     Source Type: Journal    
DOI: 10.2174/1381612821666150901105146     Document Type: Article

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