Bioequivalence and Bioavailability Forum

❝ 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)
  

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• Page 8, 5. Sensitivity (⇒ Table 1)
  

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• Page 9, 7. Stability (⇒ Table 1)
  

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• Page 10, 8. Dilution Effects (⇒ Table 1)
  

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• Page 12, C. Validated Methods: Expectations of In-Study Analysis and Reporting (⇒ Table 1)
  

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• Page 13, last bullet point (⇒ Table 1)
  

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• 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.