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Group,
A very happy new year to you all and let's keep the scientific temper
high thro this discusssion forum.
Now, coming to my query:
We are developing a generic equivalent of an innovator product, the
strength of which is 0.25 mcg.Considering that I get a satisfactory
invitro matching (Dissolution profile matching)with the innovator, is
there any possibility of getting a biowaiver based on the following
points:-
1.Low strength and thus very low detection levels in the body,
requiring very sensitive and accurate analytical methodology.
2.Presence of similar endogenous compounds in the body/plasma at
almost the similar levels and thereby interfering with the analysis.
3.The drug is formulated as a suspension encapsulated as a Soft
gelatin capsule for immediate release.
Your views on the same shall be of immense help to me.
Thanks and regards
K.Natrajan
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The following message was posted to: PharmPK
Not being able to demonstrate PK equivalence does not waive demonstration
of PD equivalence. See albuterol guidance from OGD. In addition, data has
to be provided to support all the claims made in item1-3.
Good luck!
MH
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As my understanding from October 2000 guidance, waiver of in vivo studies
may be requested, if
1-the drug substance is highly soluble and highly permeable
2-the drug product dissolves quickly (e.g.., >85% with in 30 minutes) in
physiological pH range (e.g., at pH 1.3, to 6.8)
3-the drug substance does not have a narrow therapeutic index.
From your e-mail, I understand that the dissolution profile of the drug
product is similar to brand product but how about the permeability (e.g.
different excipients??). It may be a good idea to identify the
biopharmaceutical classification of the drug product before reach any
conclusion.
Following article may be helpful on your decision:
" Advance Exp. Med. Biol", 1997;423:111-28, Corrigan O.I.
" J. Pharm Sci" 1998 Dec;87(12):1604-7, Pade, V., Stavchansky, S.,
Good luck,
Sibel Ucpinar PhD.
Cedra Corp,
In vitro Drug Metabolism Division
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)