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Patient population for bioequivalence study [Regulatives / Guidelines]

posted by pash413 - India, 2017-10-04 15:44  - Posting: # 17855
Views: 1,853

Dear All
We are planning to conduct a bioequivalence study in patient population for USFDA submission.

As per product label, the drug is used in three indications (i.e. diseases)

Out of three indication, patients comprise of two indication are difficult to recruit, because of disease criticality & severity. However for third indication, patients are abundantly available for the enrollment in to the BE study.

Considering the above fact, is it necessary to conduct bioequivalence study in all eligible patient population as per label or we can recruit only patients for third indication. Will there be any regulatory concerns in term of BE acceptance, product approval & getting marketing authorization for all indication.

Kindly share your view.

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