Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIINuisance: group effectMore than one group of subjects‘If a crossover study is carried out in two or moregroups of subjects (e.g., if for logistical reasons onlya limited number of subjects can be studied at onetime), the statistical model should be modified toreflect the multigroup nature of the study. Inparticular, the model should reflect the fact that theperiods for the first group are different from theperiods for the second group.’informalife sciencesFDA, Center for Drug Evaluation and Research (CDER)Guidance for Industry: Statistical Approaches to Establishing Bioequivalence (2001)Bioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201062 • 68
6/6 | Statistical Design and Analysis IIINuisance: group effectMore than one group of subjectsCases where ‘… the study is carried out in two ormore groups and those groups are studied at differentclinical sites, or at the same site but greatlyseparated in time (months apart, for example) […]should be discussed with the appropriate CDERreview division.’EMEA BA/BE (2001), BE GL (2010)The study should be designed in such a way that theformulation effect can be distinguished from othereffects.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201063 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence