dryogesh
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India,
2012-08-07 10:55
(5070 d 18:18 ago)

Posting: # 9044
Views: 1,346
 

 Indian regulatory requirements for reduced dosage [Regulatives / Guidelines]

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Does a Therapeutic/BE equivalence study would be enough to get an approval for a new reduced dosage form of already approved generic oncology drug? or one has to conduct all phases of trials with complete pre-clinical studies mentioned in Sch-Y.
Thanks in advance
 
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