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Dear Colleagues:
We are designing a four period replicate BE study. The study duration is
approximately 6 weeks including wash out phases. Are there any regulatory
limitations on the total volume ( say 850 ml for the entire study) of blood
that can be drawn from a subject. I would appreciate if anybody can guide
me if there is any guidelines that limits on amount of blood that can be
drawn from subjects in a clinical study.
Prasad Tata, Ph.D.
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Dear Prasad,
limit is based upon clinical considerations, ie a blood donation session, so
up to ca 550ml and time taken for recovery of haematol parameters - one
month. In addition to our pk samples remember to include the volumes for
blood given for safety screening and end of study examination.
Martin W Lunnon
CVS/Dyslipidaemia Clinical Pharmacology,
GWRD, Greenford
tel: +..44 (020) 8966 4456
fax + ..44 (020) 8869 1017
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