American College of Clinical Pharmacology position statement on the use of microdosing in the drug development process

Journal of Clinical Pharmacology

Volumn 47, Issue 4, 2007, Pages 418-422

  Bertino Jr , Joseph S ^a   Greenberg, Howard E ^b   Reed, Michael D ^c,d  

^a ORDWAY RESEARCH INSTITUTE   (United States)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

^c CASE WESTERN RESERVE UNIVERSITY   (United States)

^d CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

14C labeled drug; AMS; Drug development; FDA guidance; Microdosing

Indexed keywords

DIAZEPAM; ERYTHROMYCIN; FLUCONAZOLE; MIDAZOLAM; NELFINAVIR; TOLBUTAMIDE; UNCLASSIFIED DRUG; WARFARIN; ZK 253;

ARTICLE; CLINICAL TRIAL; DRUG RESEARCH; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; METHODOLOGY; NONHUMAN; POSITRON EMISSION TOMOGRAPHY; UNITED STATES;

BIOMEDICAL RESEARCH; CLINICAL TRIALS; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; PHARMACOLOGY, CLINICAL; REPRODUCIBILITY OF RESULTS; SOCIETIES, SCIENTIFIC;

EID: 33947512605     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270006299092     Document Type: Article

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