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Paresh ☆ 2012-01-27 07:47 (5248 d 23:22 ago) Posting: # 8008 Views: 5,048 |
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Dear all, I have one question regarding strength selection? If reference drug having list of strength 10mg, 20mg, 40mg, and 80mg. I have developed all strength and need to conduct BE study on highest strength 80mg. But for reference can i select dose as 2x40mg=80 for BE study. Due to un availability of reference drug as 80mg. Thanks Paresh |
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Helmut ★★★   Vienna, Austria, 2012-01-27 17:07 (5248 d 14:01 ago) @ Paresh Posting: # 8009 Views: 4,399 |
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Dear Paresh! ❝ If reference drug having list of strength 10mg, 20mg, 40mg, and 80mg. ❝ I have developed all strength and need to conduct BE study on highest strength 80mg. But for reference can i select dose as 2x40mg=80 for BE study. ❝ Due to un availability of reference drug as 80mg. Which regulation? In the US there is only one RLD – generally the highest strength. Was the 80mg strength discontinued? If yes, why? We need more information. — 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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Paresh ☆ 2012-01-28 12:29 (5247 d 18:39 ago) @ Helmut Posting: # 8010 Views: 4,551 |
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❝ Which regulation? In the US there is only one RLD – generally the highest strength. Was the 80mg strength discontinued? If yes, why? We need more information. Dear, It is for EUROPE submission. One client ask that the highest strength generally not in market. So for the same they need to conduct study as test 80mg and 2x40mg reference for BE. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2012-01-28 15:27 (5247 d 15:41 ago) @ Paresh Posting: # 8011 Views: 4,354 |
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Dear Paresh! ❝ It is for EUROPE submission. I’m not deaf. No need to shout. ❝ One client ask that the highest strength generally not in market. So for the same they need to conduct study as test 80mg and 2x40mg reference for BE.
— 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 |
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Ohlbe ★★★ France, 2012-01-28 19:20 (5247 d 11:48 ago) @ Helmut Posting: # 8012 Views: 4,339 |
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Dear Helmut and Paresh, ❝ The 80mg reference must not be on the market in any country of the EU, Norway, Switzerland,… Otherwise this reference must be used. AFAIK products from Switzerland will not be accepted as reference in the EU (no exchange of information: EU Agencies cannot be sure the composition and manufacturing process of the Swiss product are the same as for the EU product). Regards Ohlbe — Regards Ohlbe |
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Helmut ★★★ Vienna, Austria, 2012-01-28 19:30 (5247 d 11:38 ago) @ Ohlbe Posting: # 8013 Views: 4,460 |
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Dear Ohlbe and Paresh! ❝ AFAIK products from Switzerland will not be accepted as reference in the EU (no exchange of information: EU Agencies cannot be sure the composition and manufacturing process of the Swiss product are the same as for the EU product). One of our studies was accepted with a Swiss reference. Can give you the details when I’m back in Vienna. Edit: Dug it out. Manufacturer was ELAN Holdings Inc., Gainesville, USA for Novartis Pharma Schweiz AG, Bern, Switzerland. The reference was used according to the ‘Third Announcement for Drug Research in Humans’[1] and the mutual recognition of Good Manufacturing Practice (GMP)-conformed production of drugs between the European Union (EU) and Switzerland.[2] SwissMedic’s registration number (Zulassungsnummer) and the SmPC had to be provided to the BfArM where the protocol was approved in 2005.
— 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 |
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Ohlbe ★★★ France, 2012-01-28 23:31 (5247 d 07:38 ago) @ Helmut Posting: # 8014 Views: 4,321 |
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Dear Helmut, ❝ One of our studies was accepted with a Swiss reference. ❝ ... had to be provided to the BfArM where the protocol was approved in 2005. Maybe you were lucky in 2005... But look at section 4.1.2. of the current EU guideline: For Article 10(1) and 10(3) marketing authorisation applications reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted in the Union... Regards Ohlbe — Regards Ohlbe |
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Helmut ★★★ Vienna, Austria, 2012-01-29 04:51 (5247 d 02:17 ago) @ Ohlbe Posting: # 8015 Views: 4,310 |
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Dear Ohlbe! ❝ Maybe you were lucky in 2005... But look at section 4.1.2. of the current EU guideline: […] Oh, THX! The times they are a changin'. — 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 |
Ing. Helmut Schütz