Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIINuisance: group effectIncreasing number of referrals (deficiencyletters) fromCanadaGulf States (Saudia Arabia, Emirates, Oman)Extended Statistical model (fixed effects inANOVA)GroupGroup × Treatment InteractionIf both terms are not significant (p>0.05), pooling ofgroups is justified.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201064 • 68
6/6 | Statistical Design and Analysis IIINuisance: 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. Perform at least one group in the maximum capacityof the clinical site(e.g., 24+8 instead of 16+16 for 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.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201065 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence