Back to the Top
Dear All,
I would like to know if someone has had any experience with BE study
of Topiramate Tablets 25 mg.
Regards,
Taresh Patil,
Clinical Research Associate,
Phoenix Biopharma Research Center,
Taloja.
E-mail: tareshpatil.-a-.alkem.com
Back to the Top
Dear Taresh,
We carried out a study with 28 volunteers (CVintra = 14%) and
considering time points: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5,
4, 6, 8, 12, 24, 48, 72, 96, 120h.
Regards,
Daniel Rossi de Campos
Brazil
Back to the Top
The following message was posted to: PharmPK
Dear Daniel,
Thank you for providing this information i am
intrested
in knowing the study design for a pilot bioequivalence study of
topirmate
tablets 25 mg under fasting condition.
As absorption of topiramate is not affected by
food, do
we will have to show through a pilot study that food dosent affects the
absorption of topiramate.
Regards,
Taresh Patil,
Clinical Research Associate,
Phoenix Biopharma Research Center,
Taloja.
E-mail: tareshpatil.-a-.alkem.com
Back to the Top
The following message was posted to: PharmPK
Dear Friends,
It's really good to hear from all of you regarding various issues. I
have one more query to add upon.
The innovator's drug is available in two strengths 1 mg and 5 mg but
only the 5 mg strength is mentioned as RLD in "Orange Book" by USFDA.
Can we conduct bioequivalence study of our 1 mg generic product vs. 1
mg of innovator's product (instead of 5 capsules of our 1 mg generic
vs. 1 capsule of 5 mg innovator's product)?
Our 1 mg and 5 mg generic products are not proportionally similar to
each other with respect to weight. Is there any specific guideline or
case study (accepted by USFDA) on this issue?
Hope for an early response.
Regards,
Sukhbir Singh
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Bioequivalence Study of Topiramate" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)