mittyri ★★ Russia, 2024-09-14 22:24 (50 d 03:13 ago) Posting: # 24199 Views: 984 |
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Dear All! may be someone can shed some light on the current status of guideline on quality and equivalence of topical products in EMA jurisdiction1? The consultation period is over more than 5 years ago and no updates on EMA site so far. Citing a paper with experts2: ❝ The principles defined in the EMA draft guideline on the quality and equivalence of topical products reflects the current state-of-the-art methods and are similar to those of the US-FDA. These principles have been applied in recent years and some products have been approved, which demonstrates that it is applicable; however, it could be convenient to widen the acceptance range according to the observed variability in the reference product. Everything is good to go, little amendments required. So what?
— Kind regards, Mittyri |
Helmut ★★★ Vienna, Austria, 2024-09-18 10:22 (46 d 15:15 ago) @ mittyri Posting: # 24201 Views: 785 |
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Hi Mittyri, ❝ may be someone can shed some light on the current status of guideline on quality and equivalence of topical products in EMA jurisdiction? ❝ The consultation period is over more than 5 years ago and no updates on EMA site so far. ❝ Citing a paper with experts: ❝ ❝ […] it could be convenient to widen the acceptance range according to the observed variability in the reference product. Already proposed in the draft, lines 708–715: The acceptance criteria for equivalence parameters is that the 90% confidence interval for the ratio of means of the test and comparator products should be contained within the acceptance interval of 80.00 – 125.00%, unless justified. ❝ Everything is good to go, little amendments required. So what? — 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 |
Ohlbe ★★★ France, 2024-09-18 12:26 (46 d 13:11 ago) @ Helmut Posting: # 24202 Views: 760 |
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Dear Helmut and Mittyri, ❝ Obviously the MWP (successor of the PKWP) has other priorities. I don't see it mentioned on the latest version of their 3-year work plan. — Regards Ohlbe |
Helmut ★★★ Vienna, Austria, 2024-10-03 13:44 (31 d 11:53 ago) @ Ohlbe Posting: # 24210 Views: 462 |
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— 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 |