E-DRUG: RFI: Bioequivalence and generics registration (3)
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Hi there Mr Anonymous;
I am a Regulatory Affairs specialist in a private
company and have worked on the regulated, semi
regulated and the non regulated markets for
registration of generic version of pharmaceutical
products.
When ever you say that you are establishing
Bio-equivalence between the Innovator Brand and the
New Generic, you have to carry out a bio-study. The
parameters that would be assessed are T1/2 (biological
half life), Cmax & Tmax. Now when we have these three
minimum criteria to be established to deem
bio-equivalency between two products. Secondly you
also have to know that a plain dissolution (in vitro)
profile will not suffice, it has to be a proper IVIVC
(Invitro Invivo corelation) calcutated using the f1 &
f2 values.
Now your question should a developing country ask for
these parameters...well dont we think that by laxing a
few procedures in testing you are inviting a lot of
unruly generics who would not necessarily have good
therapeutic effect but however qualify on a
physico-chemical parameter assessment and get
registered. Even small countries or developing
coutries do request a complete Bio study and it is not
difficult for new entrants to give it mainly because
they will have already carried out a bio for atleast
one market and will have it ready...so inclusion of
this in the larger interest of GOOD QUALITY MEDICATION
to the public should be the outlook. Especially if you
are in a policy making & decision making
authoratative position it would really be better if
you give it a good thought than think about how a
developing nation is going to afford this.
Regards,
Milind Nadgouda
Cadila Pharmaceuticals Limited
India
milindnadgouda@yahoo.co.uk
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