Ethical, legal, and social implications (ELSI) of microdose clinical trials

Advanced Drug Delivery Reviews

Volumn 63, Issue 7, 2011, Pages 503-510

  Kurihara, Chieko ^a  

^a NATIONAL INSTITUTE OF RADIOLOGICAL SCIENCES   (Japan)

Author keywords

Belmont report; Drug development strategy; Ethics; Human dignity; Human screening; Microdose

Indexed keywords

BELMONT REPORT; DRUG DEVELOPMENT; ETHICS; HUMAN DIGNITY; HUMAN SCREENING; MICRODOSE;

EXPERIMENTS; MEDICAL APPLICATIONS; PHILOSOPHICAL ASPECTS;

LAWS AND LEGISLATION;

ANTINEOPLASTIC AGENT; CLARITHROMYCIN; DIAZEPAM; ERYTHROMYCIN; FEXOFENADINE; MIDAZOLAM; PARACETAMOL; PHENOBARBITAL; PROPAFENONE; SUMATRIPTAN; UNCLASSIFIED DRUG; WARFARIN; ZK 253;

ANIMAL WELFARE; BENEFICENCE; DOSIMETRY; DRUG CARCINOGENICITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSAGE FORM COMPARISON; DRUG HALF LIFE; DRUG IMPURITY; DRUG LEGISLATION; DRUG MICRODOSE; DRUG SAFETY; DRUG SCREENING; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GENOTOXICITY; GOOD MANUFACTURING PRACTICE; HEALTH CARE ACCESS; HUMAN; HUMAN DIGNITY; INFORMED CONSENT; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MEDICAL ETHICS; MEDICOLEGAL ASPECT; NONHUMAN; PHARMACEUTICAL CARE; PHARMACODYNAMICS; PHARMACOKINETICS; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; RESEARCH SUBJECT; REVIEW; RISK BENEFIT ANALYSIS; RISK REDUCTION; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; SOCIAL ASPECT; SOCIAL JUSTICE;

ANIMALS; CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DESIGN; DRUGS, INVESTIGATIONAL; EUROPEAN UNION; HUMANS; INTERNATIONALITY; JAPAN; UNITED STATES;

EID: 79957709720     PISSN: 0169409X     EISSN: 0169409X     Source Type: Journal    
DOI: 10.1016/j.addr.2011.01.002     Document Type: Review

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