Bioequivalence of IR vs MR tablet [Design Issues]

posted by heritage – India, 2018-05-05 04:25  – Posting: # 18755
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One drug has been approved as IR tablet given 100 mg bid (total dose 200 mg). We want to make one ER formulation of 230 mg which can be given once daily. I need help in following issues

1. What should be the design?
2. Which PK parameter I should be looking at?
3. Should I do fasting or fed study?
4. Should I targeting BE in Cmax or AUC?

Please give me some reading material or link to any post wherein this had been already discussed

Thanks in advance


Edit: Category changed; see also this post #1. [Helmut]

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