Bioequivalence and Bioavailability Forum

Hi Scopy,

❝ ❝ Could it be that the May 24 version is the updated and thus the recommended version to use?

Yes.

❝ ❝ 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, 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.

Not unusual for the FDA to give recommendations rather than requirements. However, changing the wording was not consequent. In many places we still read e.g., “the requirements for […] are listed in Table 1.” – where only recommendations are given.

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.