Back to the Top
Dear All,
I would like to know if someone has had any experience with BE study
of rivastigmine (6mg).
regards,
Daniel Rossi de Campos
Brazil
Back to the Top
The following message was posted to: PharmPK
Dear Danniel,
Rivastigmine is listed as RLD in Orange book as 1.5mg Capsules and
6mg Capsules,conducting bioequivalence with 1.5mg does not pose any
problem but with respect to 6mg maximum number of subject will show
emesis which can be a safety concern and the study could be
nonconclusive. It is recommended to predose the subject with an
antiemetic and then dose Rivastigmine to minimize emesis.
Regards
Mkv
Back to the Top
BE with Rivastigmine 6mg is recommended to be conducted in patients
instead of healthy subjects...
It would be a good idea to seek regulatory agency's view on this
(regulatory agency of the country you are developing the drug for)..
Recently, OGD has recommended BE study in patients for a drug that
has lots of AEs at higher doses...
Cordially,
Dr. Renu Jain
Research Associate
Clinical Research & Regulatory Affairs
Torrent Research Centre,
Village: Bhat, Dist: Gandhinagar - 382 428
Back to the Top
The following message was posted to: PharmPK
Dear Renujain
I appreciate if you could send the correct link about this
matter .
Regards
Ney
Ney Carter Do Carmo Borges MD , Ph.D, FACC,FACP,FASCPT,FESC
Investigador Principal
Syncrhophar
www.synchrophar.com
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 "Rivastigmine BE" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)