Part II - BEBAC â¢ Consultancy Services for Bioequivalence

More documents

Recommendations

Info

6/6 | Statistical Design and Analysis IIISequential Designsinformalife sciencesCurrent work by D Potvin et al. (2007) seemspromisingWork backed by support form FDA, USP,Health Canada,…Likely to be implemented by US-FDAShould be acceptable as a Two-Stage Design inthe EUTwo of BEBAC’s protocols approved by BfArMand competent EC in May and December 2009Potvin D, Diliberti CE, Hauck WW, Parr AF, Schuirmann DJ, and RA SmithSequential design approaches for bioequivalence studies with crossover designsPharmaceut Statist (2007), DOI: 10.1002/pst.294http://www3.interscience.wiley.com/cgi-bin/abstract/115805765/ABSTRACTBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201056 • 68
6/6 | Statistical Design and Analysis IIIPotvin et al. (2007)Evaluate power at Stage 1Method ‘C’using α-level of 0.050If power ≥80%, evaluate BE atStage 1 (α = 0.050) and stopIF BE met,stopIf power
Page 3 and 4:
6/6 | Statistical Design and Analys
Page 5 and 6: 6/6 | Statistical Design and Analys
Page 7: 6/6 | Statistical Design and Analys
show all

Part II - BEBAC â¢ Consultancy Services for Bioequivalence

Create successful ePaper yourself

Delete template?

Save as template?

Part II - BEBAC â¢ Consultancy Services for Bioequivalence