qualityassurance ★ 2024-07-23 10:08 (106 d 22:16 ago) Posting: # 24087 Views: 1,847 |
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Dear Forum members, In case FDC (two active ingredients) with ascorbic acid is not approved in Europe. However, FDC (two active ingredients) is approved. In case if we want to apply for FDC (two active ingredients) with ascorbic acid in Europe, is it needed to conduct any safety and efficacy study in patients or only BE study will be enough justifying that ascorbic acid is used as an excipient? Regards, QA |
Ohlbe ★★★ France, 2024-07-23 11:55 (106 d 20:29 ago) @ qualityassurance Posting: # 24088 Views: 1,626 |
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Dear qualityassurance, ❝ In case FDC (two active ingredients) with ascorbic acid is not approved in Europe. However, FDC (two active ingredients) is approved. In case if we want to apply for FDC (two active ingredients) with ascorbic acid in Europe, is it needed to conduct any safety and efficacy study in patients or only BE study will be enough justifying that ascorbic acid is used as an excipient? I am not sure that I fully understand what you are trying to achieve here. If ascorbic acid is indeed only used as excipient (e.g. as antioxidant), and you are not intending to put it on the list of active substances: a BE study should be enough in module 5. You will have to justify the use of ascorbic acid in module 3, including the amount used, just like any other excipient. If you're just trying to disguise ascorbic acid as an excipient to make your life easier, but the quantity is not consistent with that use (500 mg won't do), or if you try at the same time to mention it on the SmPC elsewhere than just the list of excipients: this won't do, and you will have to provide justifications in module 5. Difficult to say which without knowing what your two active ingredients are. Could be limited to bibliography (well-established use), could need to provide more. — Regards Ohlbe |
qualityassurance ★ 2024-07-23 12:13 (106 d 20:11 ago) @ Ohlbe Posting: # 24089 Views: 1,582 |
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Dear Ohlbe, ❝ I am not sure that I fully understand what you are trying to achieve here. ❝ If ascorbic acid is indeed only used as excipient (e.g. as antioxidant). ❝ Difficult to say which without knowing what your two active ingredients are Regards, QA |
Helmut ★★★ Vienna, Austria, 2024-07-23 14:39 (106 d 17:45 ago) @ qualityassurance Posting: # 24090 Views: 1,598 |
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Hi qualityassurance, ❝ We want to register anti cold product combining with ascorbic acid. ❝ Actually ascorbic acid in our formulation will have therapeutic effect. Conclusion IMHO, such a product is a mere marketing gimmick.
— 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 |
mittyri ★★ Russia, 2024-07-23 16:54 (106 d 15:30 ago) @ Helmut Posting: # 24091 Views: 1,542 |
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Hi Helmut! Just adding fuel in the fire (warning! will be downloaded): Aspirin + C forte 800 mg/480 mg Brausetabletten — Kind regards, Mittyri |
Helmut ★★★ Vienna, Austria, 2024-07-24 13:16 (105 d 19:08 ago) @ mittyri Posting: # 24097 Views: 1,539 |
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Hi Mittyri, oh dear! The presence of period, sequence, and treatment effects were evaluated. Why the heck?For AUC0-t, a significant treatment effect was observed for ASA (p = 0.0221). So what?The lower and upper limit of the CI was below 100% … A consequence of p < 0.05.… but within the lower limit of the acceptance range of 80.00[%] Again: So what?Similar nonsense for SA. — 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 |
qualityassurance ★ 2024-07-24 13:37 (105 d 18:46 ago) @ Helmut Posting: # 24098 Views: 1,511 |
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Hello Helmut, ❝ IMHO, such a product is a mere marketing gimmick.❝ Allow me to ask the same question. As a strategy to register this product in EU, what is your suggestion? Regards, QA |
Helmut ★★★ Vienna, Austria, 2024-07-24 15:31 (105 d 16:52 ago) @ qualityassurance Posting: # 24099 Views: 1,468 |
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Hi QA, ❝ ❝ IMHO, such a product is a mere marketing gimmick.❝ ❝ Thank you for your HO. Let the BD and marketing team take the call. ❝ Allow me to ask the same question. As a strategy to register this product in EU, what is your suggestion? To give you an example: I was once asked by an innovator to develop the concept for a modified (i.e., prolonged) release formulation of a drug with a half-life of > 48 hours, which is only administered chronically. Doesn’t make any sense – a clear case of evergreening. BE of MR is much more difficult than the one of IR. Not my circus, not my monkeys. I refused. 🙈 🙉 🙊 — 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 |
mittyri ★★ Russia, 2024-07-24 18:01 (105 d 14:23 ago) @ Helmut Posting: # 24100 Views: 1,438 |
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Hi Helmut, ❝ To give you an example: I was once asked by an innovator to develop the concept for a modified (i.e., prolonged) release formulation of a drug with a half-life of > 48 hours, which is only administered chronically. Doesn’t make any sense – a clear case of evergreening. BE of MR is much more difficult than the one of IR. ❝ Not my circus, not my monkeys. I refused. A man is lucky (and wise) if he can say 'no' to work proposal due to internal concerns! — Kind regards, Mittyri |