Exploratory assessment of dose proportionality: Review of current approaches and proposal for a practical criterion

Pharmaceutical Statistics

Volumn 8, Issue 1, 2009, Pages 38-49

  Hummel, Jürgen ^a   McKendrick, Sue ^b   Brindley, Charlie ^c   French, Raymond ^d  

^a Fleming House   (United Kingdom)

^b AAI Pharma Ltd   (United Kingdom)

^c Kinet Assist Ltd   (United Kingdom)

^d CHARLES RIVER LABORATORIES   (United Kingdom)

Author keywords

Equivalence criterion; Exploratory dose proportionality; Pharmacokinetics; Power calculations; Power model

Indexed keywords

DRUG; PLACEBO;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CLINICAL STUDY; CLINICAL TRIAL; CONFIDENCE INTERVAL; DECISION MAKING; DOSE CALCULATION; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG RESEARCH; EXPLORATORY RESEARCH; HUMAN; HUMAN EXPERIMENT; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; POWER ANALYSIS; REPEATED DRUG DOSE; REVIEW; SINGLE DRUG DOSE; METHODOLOGY; PHARMACOKINETICS; STATISTICAL ANALYSIS; STATISTICAL MODEL;

CLINICAL TRIALS, PHASE I AS TOPIC; CONFIDENCE INTERVALS; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MODELS, STATISTICAL; THERAPEUTIC EQUIVALENCY;

EID: 65649128074     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.326     Document Type: Review

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