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fno ☆  Belgium, 2014-03-21 12:42 (4485 d 10:58 ago) Posting: # 12686 Views: 8,082 |
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Hello, Newly released draft FDA guidance: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations Enjoy reading, and share your first impressions! — Kind regards, Fabrice |
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Helmut ★★★  Vienna, Austria, 2014-03-21 15:10 (4485 d 08:31 ago) @ fno Posting: # 12687 Views: 6,223 |
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Hi Fabrice, THX for bringing this goody to our attention. ❝ Enjoy reading, and share your first impressions! Interesting reading matter. IMHO, the draft deserves more than the twelve (‼) comments the ANDA guidance received. Submit your comments until 19 May 2014 at www.regulations.gov (see also “Tips for Submitting Effective Comments”). — 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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manu126 ☆ 2014-05-15 12:52 (4430 d 11:48 ago) @ Helmut Posting: # 12949 Views: 2,708 |
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Hi, According to this guidance, "..."The results of a pilot study can be used as the sole basis to document BA or BE provided the study’s design and execution are suitable and a sufficient number of subjects have completed the study". I'd like to know if you ever heard about any drug that have been approved by HA (for example a new formulation) based on the results of a pilot BA study (say N=12) rather than a formal BE study?. Thanks EB |
Ing. Helmut Schütz