Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
6/6 | Statistical Design and Analysis <strong>II</strong>INuisance: group effectRecommendationsIf possible, multiple groups should be avoided.Keep the time interval between groups as short aspossible.Do not split the study into equally sized groups. Per<strong>for</strong>m at least one group in the maximum capacityof the clinical site(e.g., 24+8 instead of 16+16 <strong>for</strong> a total of 32). If a significant group and/or group × treatmentinteraction is found (preventing a pooled analysis),it may still be possible to demonstrate BE in thelargest group only.in<strong>for</strong>malife sciences<strong>Bioequivalence</strong> and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201065 • 68
Change language