ryraman2661 ☆ India, 2023-05-15 15:03 (577 d 15:50 ago) Posting: # 23554 Views: 2,586 |
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Dear Members, I have one point to be discussed in the forum. For Bioequivalence studies for EU submission, can we compare capsules VS tablets of same drug, and same strength. If yes, whether both Cmax and AUC (total) to be included in the criteria? or we can compare only AUC (total). What are the others points to be taken care. Members can give their opinion. Thanks Raman Chennai Edit: Subject line changed; see also this post #2. [Helmut] |
Helmut ★★★ Vienna, Austria, 2023-05-15 15:40 (577 d 15:12 ago) @ ryraman2661 Posting: # 23556 Views: 2,144 |
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Hi Raman, ❝ For Bioequivalence studies for EU submission, can we compare capsules VS tablets of same drug, and same strength. Yes (see the applicable guideline about ‘pharmaceutical alternatives’). ❝ If yes, whether both Cmax and AUC (total) to be included in the criteria? What do you mean by ‘AUC (total)’? You need to demonstrate BE for Cmax and AUC0-tlast (alternatively AUC0-72). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
ryraman2661 ☆ India, 2023-05-16 10:04 (576 d 20:49 ago) @ Helmut Posting: # 23558 Views: 2,134 |
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Thanks Mr. Helmet Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] ≠ Helmet |
Ohlbe ★★★ France, 2023-05-16 10:51 (576 d 20:01 ago) @ Helmut Posting: # 23559 Views: 2,089 |
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Dear Raman, ❝ ❝ For Bioequivalence studies for EU submission, can we compare capsules VS tablets of same drug, and same strength. ❝ ❝ Yes (see the applicable guideline about ‘pharmaceutical alternatives’). ... but only for immediate release products. Not for modified release. See section 1.2 of the guideline and article 10(2)(b) of Directive 2001/83/EC. — Regards Ohlbe |