Considerations for planning and designing a bioequivalence (BE ...

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Adhering to guidelines Guideline Collection http://bebac.at/Guidelines.htm Dissolution Testing, Bioequivalence <strong>and</strong> Bioavailability Strategies es | London, 27 June 2008 32 • 36
To bear in remembrance... Whenever a theory appears to you as the only possible one, take this as a sign that you have neither under- stood the theory nor the problem which it was intended to solve. Even though it’s applied science we’re dealin’ with, it still is – science! Karl R. Popper Leslie Z. Benet Dissolution Testing, Bioequivalence <strong>and</strong> Bioavailability Strategies es | London, 27 June 2008 33 • 36
Page 1 and 2: Considerations for planning and des
Page 3 and 4: Main Topics Ethical considerations
Page 5 and 6: Defining study objectives Comparati
Page 7 and 8: Assumptions World ‘Reality’ α
Page 9 and 10: Defining study objectives In vivo B
Page 11 and 12: Protocol development Whatever proce
Page 13 and 14: Protocol development Sample size pl
Page 15 and 16: Protocol development Power to show
Page 17 and 18: Highly variable drugs All (!) ANDAs
Page 19 and 20: HVDs (US/EU) Advisory Committee for
Page 21 and 22: HVDs (EU) Q & A document (cont.’d
Page 23 and 24: HVDs (US/EU) Reference Scaled ABE R
Page 25 and 26: Protocol development Analytical par
Page 27 and 28: Ethical considerations Polymorphism
Page 29 and 30: Selecting subjects NfG (Section 3.2
Page 31: Adhering to guidelines NfG (Section
Page 35 and 36: Ready for planning and designing a

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