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Different comparator batches [Regulatives / Guidelines]

posted by Pharma_88 – India, 2025-07-11 10:44 (327 d 20:51 ago) – Posting: # 24411
Views: 3,189

❝ 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

Complete thread:

Different comparator batches jansari 2025-07-10 17:40
- Different comparator batches jansari 2025-07-11 07:17
  - Different comparator batchesPharma_88 2025-07-11 08:44
- Different comparator batches dshah 2025-07-29 08:37

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