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pash413
Regular

India,
2017-10-04 15:44

Posting: # 17855
Views: 1,853
 

 Patient population for bioequivalence study [Regulatives / Guidelines]

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.
DavidManteigas
Regular

Portugal,
2017-10-06 10:34

@ pash413
Posting: # 17866
Views: 1,408
 

 Patient population for bioequivalence study

It is hard to provide a valuable opinion without knowing much details, namely whether you're talking about a biosimilar or generic. :-D

Generally, the product-specific guideline states in which condition should be bioequivalence study be performed. For instance, in USA diclofenac is approved for 3 indications but for BE only a study in subjects with osteoarthritis of the knee is required (https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm244644.pdf). If no product-specific guideline exists, I would recommend you to ask for scientific advice on which patient population should be selected for the BE study with clinical endpoint. If I were the Sponsor, I would pick the condition on which the primary endpoint presents less variability in the outcome.
pash413
Regular

India,
2017-10-06 15:33

@ DavidManteigas
Posting: # 17867
Views: 1,401
 

 Patient population for bioequivalence study

Dear David
Thanks for the reply.
We are talking about the generic drug with PK endpoint study submission.
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