balakotu
★    

India,
2017-03-21 13:16
(2563 d 22:43 ago)

Posting: # 17171
Views: 2,034
 

 HVDP for Health Canada [Regulatives / Guidelines]

Dear All,

Please clarify,

As per recent approach for highly variable drug products, health Canada accepts studies in full replicate or partial replicate design with widening of confidence intervals for AUC.

For such studies that will be conducted in full replicate or partial replicate studies for health Canada submissions, how to evaluate the subjects completing only two treatment periods; one with test product and other with reference product i.e (TR or RT).

Whether these subjects should be included or excluded for Bioequivalence assessment.

Regards
Kotu
Dr_Dan
★★  

Germany,
2017-03-21 14:10
(2563 d 21:48 ago)

@ balakotu
Posting: # 17174
Views: 1,656
 

 HVDP for Health Canada

Dear Kotu
all subjects in which a test/reference comparison is possible must be included in the statistical Analysis, i.e. a subject who misses one or two consecutive periods of four can not be excluded.

Kind regards and have a nice day
Dr_Dan
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