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RegisterDifferent comparator batches [Regulatives / Guidelines]
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
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
Complete thread:
- Different comparator batches jansari 2025-07-10 17:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different comparator batches jansari 2025-07-11 07:17
- Different comparator batches Pharma_88 2025-07-11 08:44
- Different comparator batchesdshah 2025-07-29 08:37
- Different comparator batches jansari 2025-07-11 07:17
Ing. Helmut Schütz