Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development

Clinical and Translational Science

Volumn 9, Issue 2, 2016, Pages 74-88

  Burt, T ^a   Yoshida, K ^b,c   Lappin, G ^d   Vuong, L ^e,f   John, C ^b   de Wildt, Sn ^g   Sugiyama, Y ^h   Rowland, M ^i,j  

^a Burt Consultancy   (United States)

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

^c OAK RIDGE INSTITUTE FOR SCIENCE AND EDUCATION   (United States)

^d UNIVERSITY OF LINCOLN   (United Kingdom)

^e LTV Consulting   (United States)

^f Clinical Advisor at BioCore   (South Korea)

^g SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^h RIKEN   (Japan)

ⁱ UNIVERSITY OF MANCHESTER   (United Kingdom)

^j UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; CYTOCHROME P450 2C9; CYTOCHROME P450 3A; DOXORUBICIN; FEXOFENADINE; FLUVOXAMINE; ITRACONAZOLE; KETOCONAZOLE; METFORMIN; MIDAZOLAM; MITOCHONDRIAL DNA; MULTIDRUG RESISTANCE PROTEIN; ORGANIC CATION TRANSPORTER 2; PRAVASTATIN; RIFAMPICIN; ZIDOVUDINE;

ANALYTIC METHOD; ANTINEOPLASTIC ACTIVITY; ANTIVIRAL ACTIVITY; CLINICAL TRIAL; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG COST; DRUG DEVELOPMENT; DRUG DISPOSITION; DRUG ELIMINATION; DRUG MANUFACTURE; DRUG MECHANISM; DRUG MICRODOSE; DRUG TOLERABILITY; HEALTH CARE SYSTEM; HUMAN; MAXIMUM TOLERATED DOSE; MITOCHONDRIAL TOXICITY; PATIENT ADVOCACY; PRIORITY JOURNAL; RECEPTOR BINDING; REVIEW; RISK BENEFIT ANALYSIS; RISK REDUCTION; SINGLE DRUG DOSE; CLINICAL TRIAL (TOPIC); DECISION MAKING; DOSE RESPONSE; DRUG INTERACTION; TRANSLATIONAL RESEARCH;

CLINICAL TRIALS AS TOPIC; DECISION MAKING; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DISCOVERY; DRUG INTERACTIONS; HUMANS; TRANSLATIONAL MEDICAL RESEARCH;

EID: 84963705486     PISSN: 17528054     EISSN: 17528062     Source Type: Journal    
DOI: 10.1111/cts.12390     Document Type: Review

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