Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Part II - BEBAC ⢠Consultancy Services for Bioequivalence
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6/6 | Statistical Design and Analysis <strong>II</strong>INuisance: group effectMore than one group of subjects‘If a crossover study is carried out in two or moregroups of subjects (e.g., if <strong>for</strong> 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 <strong>for</strong> the first group are different from theperiods <strong>for</strong> the second group.’in<strong>for</strong>malife sciencesFDA, Center <strong>for</strong> Drug Evaluation and Research (CDER)Guidance <strong>for</strong> Industry: Statistical Approaches to Establishing <strong>Bioequivalence</strong> (2001)<strong>Bioequivalence</strong> and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201062 • 68