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

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HVDs (EU) Questions & Answers document (July 2006) #2: referring to the NfG: “In certain cases a wider interval […] prospectively defined, e.g. 0.75 – 1.33, and justified addressing in particular any safety or efficacy concerns for patients switched between formulations”. Widening only for C max (not for AUC) exceptional, and limited to a small widening (0.75 − 1.33). Dissolution Testing, Bioequivalence and Bioavailability Strategies es | London, 27 June 2008 20 • 36
HVDs (EU) Q & A document (cont.’d) Widening for C max Restricted to products for which at least one of the following criteria applies: 1) Data on PK/PD relationships (safety and efficacy) adequate to demonstrate that PD is not affected in a clinically significant way. 2) If PK/PD data are inconclusive or not available, clinical safety and efficacy data may be used, but specific for the compound and persuasive. 3) Reference product is a HVDP. See #8 of the Q&A document. Different interpretation of both the NfG and the Q&A document within the European Union.*) *) European Generic Medicines Association 1 st EGA Workshop on Bioequivalence Study Design, Working to GCP and Interpreting the Guidelines Lisbon, October 23 rd -24 th , 2007 Dissolution Testing, Bioequivalence and Bioavailability Strategies es | London, 27 June 2008 21 • 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: HVDs (US/EU) Advisory Committee for
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 and 32: Adhering to guidelines NfG (Section
Page 33 and 34: To bear in remembrance... Whenever
Page 35 and 36: Ready for planning and designing a

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