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balaji more ☆ 2008-01-11 10:33 (6739 d 02:26 ago) Posting: # 1507 Views: 4,472 |
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In which phase of clinial development (Phase I, II, III, IV) the bioequivalence studies fall? Balaji |
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Jaime_R ★★ Barcelona, 2008-01-11 12:32 (6739 d 00:26 ago) @ balaji more Posting: # 1508 Views: 3,620 |
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Dear Balaji! Phase I - though some nitpickers claim that the innovator's reference product is already in Phase IV (naming this type of study Phase I/IV)... — Regards, Jaime |
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Rajdeep ★ New Delhi, India, 2008-01-14 08:41 (6736 d 04:18 ago) @ balaji more Posting: # 1513 Views: 3,611 |
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According to me, BA/BE studies does not fall under any of the above phases. Its a clinical study that is different from all of it. There we have trials on new drug, but here the drug is generic. So no chance of categorizing BA/BE study in the above phases.  — Best regards Rajdeep Mukherjee Protocol Developer |
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Jaime_R ★★ Barcelona, 2008-01-14 13:46 (6735 d 23:13 ago) @ Rajdeep Posting: # 1515 Views: 3,556 |
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Dear Rajdeep! ❝ According to me,... That's a reference.  ❝ ... BA/BE studies does not fall under any of the above phases. Its a ❝ clinical study that is different from all of it. There we have trials ❝ on new drug, but here the drug is generic. So no chance of categorizing ❝ BA/BE study in the above phases. I think that your opinion is rather solitary... Just a reminder: BE studies are not essentially the comparison of a generic with an innovator's reference. Examples of BE studies an innovator company performs (sometimes strict BE; sometimes only by design): * BE between the formulation intended for MA vs. Phase I-III formulations * Food studies * PK interaction studies * Dose proportionality studies — Regards, Jaime |
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