The impact of missing values in the concentration-time curve on the assessment of bioequivalence

Pharmaceutical Statistics

Volumn 4, Issue 2, 2005, Pages 91-99

  Donner, Allan ^a,c   Hauck, Walter W ^b   Zou, Guangyong ^a,c  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

^c ROBARTS RESEARCH INSTITUTE   (Canada)

Author keywords

Concentration time curve; Confidence interval estimation; Missing values; Pharmacokinetic parameters; Two one sided t tests

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL STUDY; CONFIDENCE INTERVAL; DRUG BIOAVAILABILITY; DRUG FORMULATION; GEOMETRY; PROBABILITY; SIMULATION; STATISTICS;

EID: 21244461863     PISSN: 15391604     EISSN: None     Source Type: Journal    
DOI: 10.1002/pst.156     Document Type: Article

References (5)

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3. Health and Welfare Canada. Drugs directorate guidelines: conduct and analysis of bioavailability and bioequivalence studies. Ottawa, Ontario, 1992.
4. Gaudreault J, Potvin D, Lavigne J, Lalonde RL. Truncated area under the curve as a measure of relative extent of bioavailability: evaluation using experimental data and Monte Carlo simulations. Pharmaceutical Research 1998; 15(10): 1621-1629.
5. Schuirman DJ. A comparison of the two-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics 1987; 15:657-680.