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Hi,
I've read that subjects who vomit within 2x median Tmax in a BE study
should be dropped from analysis. Does this rule also apply to a
study where several dose cohorts (of the same drug) are characterized
for PK and compared?
Thx,
Young
Young Kim
Biostatistician
DP Clinical Associates Inc.
1803 Research Boulevard, Suite 404
Rockville, MD 20850
Tel.: 301-294-6226
Fax: 301-294-6338/4561
www.dpclinical.com
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The following message was posted to: PharmPK
IMHO it depend about the administration routes and about the
pharmacological formulation (sachet, slow release tablets etc).
If the AUC of the subject is not statistically different from other
AUC I believe that he can be considered for the study.
best regards
Fabio Macchi
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The following message was posted to: PharmPK
Dear Forum.
IMHO Young Kim's question about vomiting in a BE study (discard data if
vomiting occurs before twice the median Tmax) should be widened to
nausea
because nausea is a precursor of vomiting and whenever I have been
able to
measure gastric emptying in a situation where nausea existed (eg: during
migraine and after opiates) it was markedly delayed and that would
clearly
affect the PK profile. Therefore on that basis alone I would not
consider
any subject's PK profile during nausea or vomiting to be comparable
to the
others.
If I may make a more general observation, this is a good example of a
narrow
focussed "rule" giving a false sense of security to those who follow it
blindly. This encouraged no doubt by the use of reassuring technical
terms
like median, since that suggests a prudent avoidance of the
assumption that
the data is normally distributed.
Andrew Sutton
--
Andrew Sutton, MBBS, MD(London), FFA
Guildford Clinical Pharmacology Ltd.
The Technology Centre, Occam Road
Guildford, Surrey, UK. GU2 7YG
Tel: +44 (0)1483 455375. Direct: 688303
Mobile +44 (0) 7770 820 145 (To 5pm EST)
URL: www.gcpl.co.uk
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