Requirements ⇒ recommendations [BE/BA News]
❝ ❝ Could it be that the May 24 version is the updated and thus the recommended version to use?
❝ ❝ Was also wondering what was the modification done
Unfortunately most regulatory documents are published without track changes. Not uncommon that older versions are overwritten (worst example: the EMA’s 15 versions of the Q&A document).
❝ I have skimmed through both documents. I did not notice any difference …
Not surprising. I used an online tool. Requirement(s) in the version of May 21 changed to recommendation(s):
- Page 5, 5th bullet point (⇒ Table 1)
- 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
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.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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