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The following message was posted to: PharmPK
Dear Sir,
I am working in one pharmaceutical company which has it's own
Pharmacokinetic Unit to carried out all inhouse Bio-Equivalence Studies
for Regulatory purpose. I am working as a Bio-Statistician in it. Now I
would like to know about BRAZILLIAN GUIDLINES related to Biostatistics
& Datamanagement in Clinical Research. In near future we are expecting
Brazillin Inspection to approve our Pharmacokinetic Unit. So which type
of queries / questions they may ask to me (a bio-statistician) related
to BE studies or Clinical Trials or any related area of Bio-Statistics.
Kindly reply me on urgent basis..
Thanking you in advance...
With Regards
RONAK PATEL
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The following message was posted to: PharmPK
Ronak Patel,
The Brazillian Inspection may ask you about your SOP of statistics that
may
include this points:
1)Design of Bioequivalence studies, 2)Power and sample size
determination
and 3)statistical methods for average bioequivalence.
This article may help you with sample size and its references with
others
topics (1 and 3):
E.Diletti,D.Hauschke and V.W.Steinijans. Sample size determination for
bioequivalence assessment by means of confidence intervals.
International
Journal of Clinical Pharmacology, Therapy and Toxicology,
vol.29(1):1-8,1991
Another reference is the book of Shein-Chung Chow and Jen-Pei Liu and
the
FDA guidance of statistics:
Design and Analysis of Bioequivalence Studies
Guidance for Industry - Statistical Approches to establishing
Bioequivalence
- January 2001
This topics are in the document of ANVISA (Brazilian Health
Authorities)edited in this year. The name of this document is: "Manual
de
Boas Prática em Biodisponibilidade e Bioequivalencia - volume 01" ( Good
Laboratory Practices to Bioavailability and Bioequivalence studies -
vol 01)
If you have new questions, contact me.
with regards,
Daniel Rossi de Campos
Brazilian Consultant of Bioequivalence
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)