Meeting the MIST regulations: Human metabolism in Phase I using AMS and a tiered bioanalytical approach

Bioanalysis

Volumn 4, Issue 4, 2012, Pages 407-416

  Lappin, Graham ^a   Seymour, Mark ^a   Gross, Gerhard ^b   Jørgensen, Martin ^b   Kall, Morten ^b   Kværnø, Lisbet ^b  

^a Xceleron Inc   (United States)

^b H LUNDBECK A S   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

CARBON 14; RADIOISOTOPE;

ANALYTIC METHOD; AREA UNDER THE CURVE; DOSIMETRY; DRUG ABSORPTION; DRUG EXCRETION; DRUG INDUSTRY; DRUG METABOLISM; DRUG RESEARCH; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; ISOTOPE LABELING; MASS SPECTROMETRY; NONHUMAN; PROCESS DEVELOPMENT; PROTON NUCLEAR MAGNETIC RESONANCE; QUALITY CONTROL; REVIEW;

AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; BIOTRANSFORMATION; CARBON RADIOISOTOPES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CLINICAL TRIALS, PHASE I AS TOPIC; DRUG EVALUATION, PRECLINICAL; DRUG TOXICITY; DRUGS, INVESTIGATIONAL; HUMANS; MASS SPECTROMETRY; PRACTICE GUIDELINES AS TOPIC;

EID: 84858017536     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.334     Document Type: Review

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