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hi everyone
I have got one doubt ie when we can go for waiver of be studies.
As i know when we have 3 products in the following strength 1mg,10mg,
50mg.
Nomally the regulatory people accept to do the highest concn.
But if i am formulating the lower strength after 2 years of BE study
ie if i want to go for BE study for 1mg, is must to do the BE studies
or can go for waiver since i have done BE study for 50mg.
Kindly give the details.
naga.
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The following message was posted to: PharmPK
You can still get a waiver if your product with higher strength is
already
approved. Waiver for the lower strengths can be granted as per the
guidance, based upon the dose proportionality and dissolution
similarity.
Also you can go for supplimenting your earlier approved ANDA by
providing
the waiver request for the lower strength. Hope this calrifies
something.
Manoj Kumar Vishwakarma
Group- Leader
Biopharmaceutics
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Dear naga,
What is important here is to see which is the RLD for your drug
product(reference listed drug). If 50 mg is your RLD, you can go for
asking waiver for your both of lower strengths.
Hope i have answered to your query.
SCM
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