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General BE topics [Design Issues]

posted by VSL - India, 2017-06-05 20:34  - Posting: # 17444
Views: 658

Dear all,
Could you please give your views on the following topics?
  1. Half-life: Is half life independent of formulation effect? I mean, IR vs. MR products of the same substance. I am asking as protocol design depends a lot on it.
  2. High variable drug substance vs. High variable drug products, Is there is any demarcation for protocol design aspects?
  3. If there are two strengths, say, tablet, 10 and 20 mg and 20 mg is RLD. The company wishes to market only 10 mg strength but 10 mg is not RLD. What should be RLD in BE study? Is comparison of 10mg x2 tablets (test) vs. 20mg RLD right?
  4. What is the minimum sample size for parallel group BE study?
  5. For endogenous substances, how many and for how much time duration (-48 hours etc.) baseline samples should be collected?
  6. Why passing ratio is high for BE studies (especially pivotal studies) conducted in India compared to foreign countries? Is there any geographical/ethnic/staff expertise/deliberate effect?
  7. For some therapeutic class drugs BE study, I have not seen any PD effect. Example, For Antihypertensive drugs, no change in BP in vital recordings even at/around Cmax. Please explain.

Thanks and Regards,
VSL

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