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Sample Size and Power Analysis in Bioequivalence Studies

Sample Size and Power Analysis in Bioequivalence Studies

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Published by: Prof. Dr. Tasneem Ahmad on Feb 18, 2009
Copyright:Attribution Non-commercial

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07/30/2013

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02/18/09Prof. Dr. Tasneem Ahmad, CBSBR, Uni 1
Prof. Tasneem Ahmad
 B.Pharm, M.Pharm, Ph.D.
Project Director
Center for Bioequivalence Studies and Bioassay Research
International Center for Chemical and Biological Sciences
University of Karachi - Pakistan
 
02/18/09Prof. Dr. Tasneem Ahmad, CBSBR, Uni 2
Selection of BE StudyDesign Estimation ofSample Size(
number ofvolunteers
)Calculation of Bioavailability (BA) andPharmacokinetic (PK)Parameters
AUC
0
-t
Area under the curve 0-t
Elimination
Rate Constant and Half Life
AUC
0
-
 
Area under the
 
curve 0-∞
 
t
max
Time of C
max
in the plasma profile
C
max
Maximum concentration
LogarithmicTransformationMeasuringConfidence IntervalTesting the initialHypothesis and Power  assumptions
02004006008001000051015hr 
    m    c    g     /    m     L
 
02/18/09Prof. Dr. Tasneem Ahmad, CBSBR, Uni 3
Before a clinical trial is conducted , design ofstudy has to be selected .The choice of the design depends primarily on thevariability in the observations i.e., the individualssubjects may differ very widely in their responsesto the drug products.Thus , one major source o f variability arises fromdifferences between subjects. As a result criterionfor choosing an appropriate design is whether ornot the selected design can identify, estimate andisolate the intersubject variability in the dataanalysis.Any design that can remove this variation fromthe comparison in average bioavailability betweenformulations would be the appropriate one.
Crossover design
is also a design of that type andcommonly used in bioequivalence studies.
 
Selection of BE Study Design

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