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.
is also a design of that type andcommonly used in bioequivalence studies.
Selection of BE Study Design