Bioequivalence and Bioavailability Forum • upper limit blood loss

maverick
☆

India,
2010-04-27 13:08
(5907 d 14:37 ago)

Posting: # 5244
Views: 6,640

upper limit blood loss [Regulatives / Guidelines]

dear all,
what is the upper limit for accepted blood volume that can be withdrawn for a BE study in healthy human beings.
i would like to know the regulators/guidelines specifications.
also what is the limit an IRB/IEC can approve.

in general for a typical bio study, the blood wont exceed more than 400 mL, however there are atypical studies in which we need to design a four period replicate, containing double or triple analytes to be measured and add to this sponsor seeks double aliquots of plasma samples. under such conditions the total volume of blood loss exceeds 700 mL.
so my question is how can we perform the study with such mammoth blood draw.
also getting the IRB approval is very difficult.

plz clarify

thanks!!

Jaime_R
★★

Barcelona,
2010-04-27 13:31
(5907 d 14:14 ago)

@ maverick
Posting: # 5245
Views: 5,181

upper limit blood loss

Post reply

Dear Maverick,

see this thread first. AFAIK no guideline, but limited to the volume of a normal blood donation (500 ml) by the ethics committee. In my experience IECs are flexible, if the volume is slightly exceeded and longer washout periods + HBe monitoring is employed.
And yes, replicate designs are problematic. Do you really need a full 4-period design, or is a partial replicate enough? Also problematic: all higher-order designs, dose proportionality,...
I'm afraid, as a last resort you have to improve analytics.

—
Regards, Jaime

suds4u
☆

India,
2010-04-28 11:36
(5906 d 16:09 ago)

(edited on 2010-04-28 12:12)
@ maverick
Posting: # 5251
Views: 5,027

upper limit blood loss

Post reply

Dear maverick
I do not know where you want to do the study, but in the ethical guideline of ICMR has defined this

from healthy adults and non-pregnant women who weigh normal for their age and not more than 500 ml blood is drawn in an 8 week period and frequency of collection is not more than 2 times per week;
from other adults and children, where the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected has been considered and not more than 50 ml or 3 ml per kg, whichever is lesser is drawn in an 8 week period and not more than 2 times per week;

And also very important, as discussed depends on the ethics committee which provides approval for the protocol.
Ethics may deny the permission if it exceeds the limit specified and you have to relook into the time points of the draw and frequency of washout period also.

Regards
Suds

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post!
@Maverick: You find the document (3.1MB!) at the Guideline Collection; the section quoted by Suds is at p14. [Jaime]