jansari
☆    

India,
2025-07-10 19:40
(337 d 13:35 ago)

Posting: # 24409
Views: 3,834
 

 Different comparator batches [Regulatives / Guidelines]

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Hi,

Kindly help me out for following question::

Is the use of a single batch of comparator product in Bioequivalence study mandatory or we can use multiple batches ?
If any regulatory guidance please share the guidance docs..

Quick response is highly appreciated…
 
jansari
☆    

India,
2025-07-11 09:17
(336 d 23:58 ago)

@ jansari
Posting: # 24410
Views: 3,248
 

 Different comparator batches

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Awaiting for the reply

Edit: 😴 Relax; 13½ hours ≠ two weeks. See also there (second paragraph). [Helmut]
 
Pharma_88
★    

India,
2025-07-11 10:44
(336 d 22:31 ago)

@ jansari
Posting: # 24411
Views: 3,211
 

 Different comparator batches

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❝ Awaiting for the reply


Hi,

Different RLD may add variations in the BE study and it is entirely depend upon the batch to batch variation and further statistical analysis should be done using combined data only and no adjustments to be made based on the different RLD used.


Reagrds,
Pharma_88
—
Regards,
Pharma_88
 
dshah
★★  

India,
2025-07-29 10:37
(318 d 22:38 ago)

@ jansari
Posting: # 24418
Views: 2,932
 

 Different comparator batches

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Hi Jansari!

There were few presentation by FDA about using more than one RLD in a single BE study during Covid period. There can be multiple challenges like - assay difference, dissolution difference and anticipated additional variability which may increase the risk.

Divyen
 
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