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Ohlbe ★★★ France, 2013-09-12 17:44 (4667 d 06:32 ago) Posting: # 11486 Views: 4,378 |
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Dear all, The FDA just released the draft revision of their bioanalytical method validation guidance, for a 90-day consultation period. — Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2013-09-12 18:22 (4667 d 05:53 ago) @ Ohlbe Posting: # 11487 Views: 3,741 |
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Dear Ohlbe, THX! ❝ […] for a 90-day consultation period. Wow, that’s an improvement. Still requiring recovery (what for?). At least they have managed to copypaste carryover from EMA’s GL.  7% ISRs, why not. Suggesting to run even a pilot study – not a bad idea.Comments until 12 December 2013 to 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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ElMaestro ★★★ Denmark, 2013-09-12 19:23 (4667 d 04:53 ago) @ Ohlbe Posting: # 11488 Views: 3,775 |
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Hi Ohlbe, thanks for the link. Makes good reading. I was hoping they would be more explicit about the required quality standard. In relation to human BA/BE they just refer to 21CFR320.29, which isn't so informative and leaves a lot of room for interpretation. Most analytical validations from US-based CROs I have seen do actually include a GLP compliance statement. Arguably there is a bit of scope clutter with 21CFR58, though. — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2013-09-26 00:34 (4653 d 23:42 ago) @ Ohlbe Posting: # 11562 Views: 3,504 |
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Dear all, The AAPS and the FDA are organising a new "Crystal City" meeting (this time in Baltimore, not in Crystal City !) to discuss the draft revised guidance. Dates: 3 to 5 December 2013. More details here. — Regards Ohlbe |
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Helmut ★★★ Vienna, Austria, 2013-09-26 01:15 (4653 d 23:01 ago) @ Ohlbe Posting: # 11563 Views: 3,432 |
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Dear Ohlbe and all, THX, have to find a patron paying for me. BTW, hopefully line 416 is meant as a joke? — 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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Helmut ★★★ Vienna, Austria, 2013-12-04 23:02 (4584 d 00:14 ago) @ Ohlbe Posting: # 12004 Views: 3,059 |
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Dear all, if you didn’t submit your comments yet – still one week to go: www.regulations.gov (see also “Tips for Submitting Effective Comments”). — 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