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qualityassurance ★ 2024-07-02 10:32 (370 d 05:59 ago) Posting: # 24052 Views: 3,595 |
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Dear Forum members, We have conducted a BE study with test product having PSD of X micron API. Now due to patent issue we want to decrease PSD of API to Y micron. Test product is BCS class 3 molecule. Do we need to conduct BE study again due to change in PSD of API? Our target submission is EMA. Regards, QA |
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Helmut ★★★   Vienna, Austria, 2024-07-02 11:37 (370 d 04:53 ago) @ qualityassurance Posting: # 24053 Views: 2,884 |
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Hi QA, IMHO, this is Type-II Variation (according to the EMA’s Q&A ‘a change that may have a significant impact on the quality, safety or efficacy of the medicinal product’), and, thus, an in-vivo study is required. See also EC 2013/C 223/01, Section B.II.b.3.b). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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qualityassurance ★ 2024-07-02 13:29 (370 d 03:01 ago) @ Helmut Posting: # 24054 Views: 2,865 |
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Dear Helmut, Thank you for the response. Is it possible to waive in-vivo study if we achieve similar in-vitro dissolution profile in multimedia between test products (BE batch vs new formulation) having different particle size? Regards, QA |
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SMA ☆ Europe, 2024-07-02 18:27 (369 d 22:03 ago) @ qualityassurance Posting: # 24055 Views: 2,895 |
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Dear QA ❝ Is it possible to waive in-vivo study if we achieve similar in-vitro dissolution profile in multimedia between test products (BE batch vs new formulation) having different particle size? BCS based biowaivers for class III products are possible according to the ICH M9 guideline which has already reached Step 5 in Europe (i.e. has been implemented). However all of the conditions required for a Class III waiver have to be met and this goes beyond simply showing dissolution similarity. |
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Relaxation ★ Germany, 2024-07-04 14:19 (368 d 02:11 ago) @ SMA Posting: # 24061 Views: 2,713 |
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Hello everybody ❝ However all of the conditions required for a Class III waiver have to be met and this goes beyond simply showing dissolution similarity. And as I happen to have the ICH M-9 just in front of me for other reasons, I cite chapter 3 first paragraph: "A drug product is eligible for a BCS-based biowaiver ... drug product is the same dosage form and strength" Best regards! |
Ing. Helmut Schütz