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RegisterRequirements ⇒ recommendations [BE/BA News]
» Not surprising. I used an online tool. Requirement(s) in the version of May 21 changed to recommendation(s):Page 8, 5. Sensitivity (⇒ Table 1)
» Page 9, 7. Stability (⇒ Table 1)
» Page 10, 8. Dilution Effects (⇒ Table 1)
» Page 12, C. Validated Methods: Expectations of In-Study Analysis and Reporting (⇒ Table 1)
» Page 13, last bullet point (⇒ Table 1)
» Pages 20–27, VII. Appendix, Table 1.
» VIII. Glossary, Batch
» old:
» new:
Wow, thanks. Now I know the reason for the update. No more pondering. Mucho Gracias
- Page 5, 5th bullet point (⇒ Table 1)
» VIII. Glossary, Batch
» old:
A batch is a number of unknown samples from one or more patients in a study and QCs that are processed at one time.
» new:
For purposes of this guidance, a batch is a number of unknown samples from one or more patients in a study and QCs that are processed at one time.
Wow, thanks. Now I know the reason for the update. No more pondering. Mucho Gracias
—
Scopy
Scopy
Complete thread:
- New FDA BMV guideline Ohlbe 2018-05-21 16:28 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- What a monster! Helmut 2018-05-21 17:47
- What a monster! jag009 2018-05-24 03:19
- Two Versions: May 21 & May 24 Obinoscopy 2018-07-29 18:13
- What a monster! jag009 2018-05-24 03:19
- Repeats as part of investigations, ja oder nein? ElMaestro 2018-05-22 00:17
- Repeats as part of investigations, ja oder nein? Ohlbe 2018-05-22 12:02
- Two Versions: May 21 & May 24 Obinoscopy 2018-07-30 20:41
- Requirements ⇒ recommendations Helmut 2018-08-01 11:12
- Requirements ⇒ recommendationsObinoscopy 2018-08-02 22:59
- Requirements ⇒ recommendations Helmut 2018-08-01 11:12
- Two Versions: May 21 & May 24 Obinoscopy 2018-07-30 20:41
- Repeats as part of investigations, ja oder nein? Ohlbe 2018-05-22 12:02
- What a monster! Helmut 2018-05-21 17:47
Ing. Helmut Schütz