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Dear Members,
1. In case a particular strength of the powder for injection product is
meant for both IM / IV route of administration then do we need to
perform
the Bio equivalence study on the situation when less amount of diluent
addition will make this powder for injection as aqueous Suspension,
ready
for IM injection, whereas high amount of diluent addition will make the
same product as Clear solution ready for IV administration. This
solubility
criteria is solely on the basis of solubility profile of a particular
API
and the injection product contains API only without any excipients /
solubilizers / buffers etc.
2. Are there any standards available with US FDA / UK MHRA, whereby it
becomes mandatory to check the reconstitution time of a given powder for
injection. What if we are exceeding few seconds from US innovator
samples.
The rationale behind such query is - In case where the reference
product is
sterile- Lyophilized amorphous powder for Injection, WHEREAS the generic
product is sterile- Crystalline powder for reconstitution. What if It
takes reference product to dissolve in 30 seconds with minimal shaking
whereas Test product takes 50 seconds with vigorous shaking, on adding
similar amount of diluent. Rest of the parameters like Potency,
stability,
impurity profile is comparable to reference formulation.
Are there any clear guideline to review such kind of quality issues or
should it handled at the individual organizational quality assurance
levels.
Kindly share your expert opinion and oblige.
Thanks,
Ashish Gogia
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)