Bioequivalence and Bioavailability Forum • Requirements ⇒ recommendations

Requirements ⇒ recommendations [BE/BA News]

posted by Obinoscopy – Nigeria, 2018-08-02 22:59 – Posting: # 19129
Views: 1,556

» Not surprising. I used an online tool. Requirement(s) in the version of May 21 changed to recommendation(s):

Page 5, 5^th 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
» 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