[e-drug] therapeutic equivalence of different dosage forms? (6)

["Rakesh Chaurasia" <chaurasiarakesh@macleodspharma.com>]

E-DRUG: therapeutic equivalence of different dosage forms? (6)
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Respected Mr. Robert Ancuceanu,

In my opinion, there will not be any difference in the therapeutic efficacy
of 100ml vs 200ml as long as the composition remains same and there is no
change in packaging material specifications apart from the volume.

In any case, in my opinion, manufacturer should conduct stability study on
200ml pack against the specification set for 100ml product and if stability
result is satisfactory, the approval should be granted.

Regards,

Rakesh Chaurasia
Dy. General Manager-Drug Regulatory Affairs,
Macleods Pharmaceuticals-Mumbai
India
chaurasiarakesh@macleodspharma.com