Presenter flags missing comparative dissolution and failed BE studies as major deficiencies

On in vitro data the presenter cautioned that missing comparative dissolution (both test and RLD) in the recommended media for each strength is a major deficiency and that these data are often placed in module 2.7 or module 5. "The major deficiency in this space is missing comparative both test and RLD dissolution data and in the recommended media for both Casa Nardi and for each strength," the official said.

For in vivo submissions, the official warned that providing a failed BE study without demonstrating bioequivalence to the brand is a major deficiency. He also noted missing long-term storage stability in BE summary tables or insufficient sample storage days can count as major deficiencies under the BE summary requirements.