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Helmut ★★★   Vienna, Austria, 2006-05-25 15:33 (6401 d 11:28 ago) Posting: # 137 Views: 10,122 |
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Dear all, EMEA recently published a “Concept paper for an Addendum to the Note for Guidance on the Investigation of Bioavailability and Bioequivalence: Evaluation of Bioequivalence of Highly Variable Drugs and Drug Products”. Scaled average bioequivalence (SABE) is under consideration. The deadline for comments (by international scientific societies in statistics and in pharmacokinetics) is 31 July 2006; comments should be provided to ![[image]](img/email.png) monika.croton![[image]](https://static.bebac.at/img/at.png) emea.eu.int (Fax +44 20 7418 86 13).Unfortunately the document (dated 27 April 2006) was distributed by EMEA’s mailserver on 23 May 2006, which cuts down the response time to just two months  The document is available at the EMEA (36kB PDF): Edit: the document was removed from the EMEA’s website in October 2007. A copy is available at our site. — 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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joyjac ★ Philippines, 2006-10-03 08:03 (6270 d 18:58 ago) @ Helmut Posting: # 266 Views: 7,372 |
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Hi Helmut, We are looking forward to this. Thanks. |
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Helmut ★★★ Vienna, Austria, 2007-11-02 20:57 (5875 d 05:04 ago) @ joyjac Posting: # 1269 Views: 7,109 |
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Dear Joy and all others! ❝ We are looking forward to this. It will take some time... During EGA’s BE workshop last week (more than 80 members of regulatory authorities were attending) some kind of a “roadmap” was presented. HVD(P)s will be covered by the new version of the European BA/BE guideline (no separate document is to be expected). Scaled ABE is currently under discussion, but personally I would consider any application without a Scientific Advisory Meeting still a very risky business. The drafted guideline (for comments) is expected for autumn 2008, the final version for 2008/2009.  — 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