Back to the Top
Can we get the biowaiver for Acetaminophen (paracetamol) Immediate
release Tablet.
With Regards,
Back to the Top
The following message was posted to: PharmPK
Hi All
Yes, you can. Look to the Orange-book by the FDA
With best of luck
Back to the Top
Dear Sir,
As acetaminophen comes under BCS class III drugs , please let me know
how can we get biowaiver for this drug.
Regards,
Tushar Nahata
Sr Research Executive
Panacea Biotec Pvt Ltd
Lalru,(HR) India
Back to the Top
The following message was posted to: PharmPK
Hai
DESI (Drug Efficacy Study Implementation) effective drug for which there
are no known or suspected bioequivalence problems, and as such is rated
"AA"
Regards
Chander kazipeta
Back to the Top
The following message was posted to: PharmPK
Hi Tushar,
Biowaiver for acetaminophen? I haven't heard of biowaiver for
acetaminophen.
I think members of this group can put their experiences with
acetaminophen.
Bye
Back to the Top
The following message was posted to: PharmPK
Dear Tushar,
you wrote:
> Can we get the biowaiver for Acetaminophen (paracetamol) Immediate
> release Tablet.
Yes, but: Whenever answering questions concerning regulatory approval
please indicate the 'target' country (national regulations differ).
Acetaminophen (Paracetamol) is considered a BCS Class III drug
(borderline Class I).
L Kalantzi, C Reppas, JB Dressman, GL Amidon, HE Junginger, KK Midha, VP
Shah, SA Stavchansky, DM Barends
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms:
Acetaminophen (Paracetamol)
J. Pharm. Sci. 95(1), 4-14 (2006)
available for download at FIP's website:
http://www.fip.org/www/index.php?page=pharmacy_sciences&pharmacy_sciences=ps_sig_bcs
Helmut
--
Ing. Helmut SchAtz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
e-mail helmut.schuetz.at.bebac.at
web http://bebac.at/
contact http://bebac.at/Contact.htm
forum http://forum.bebac.at
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 "Acetaminophen biowaiver" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)