Back to the Top
Dear All,
1. For BE study if we include both male and female subjects in the
study, do the number of female and male subjects need to be equal and
can we combie data from both sex and then analyse.
2. Another point is about fed condition in BE, the amount meal
that Canadian-FDA suggest ( 2 eggs fried in butter, 2 stips of bacons,
2 lides of toast, 120 g harshed brown potato, 240 ml of milk) seems to
be to much for asian subjects, some of them could not finish their
meal and about to vomit. Is anyone have experience with this type of
study?
Best Regards,
Wichittra
Back to the Top
> 1. For BE study if we include both male and female subjects in the
> study, do the number of female and male subjects need to be equal and
> can we combie data from both sex and then analyse.
Attempt should be made to enroll equal numbers of male and female
volunteers...however, it is not mandatory...and yes, the data analysis
is to be done taking into consideration all the volunteers,
irrespective of gender...analysis of data separately from males and
females is not required...
> 2. Another point is about fed condition in BE, the amount meal
> that Canadian-FDA suggest ( 2 eggs fried in butter, 2 stips of
bacons,
> 2 lides of toast, 120 g harshed brown potato, 240 ml of milk) seems
to
> be to much for asian subjects, some of them could not finish their
> meal and about to vomit. Is anyone have experience with this type of
> study?
We have also found such difficulty...moreover, we have substantial
number of veg population also...what we do is change the menu
maintaining the calories and bulk as suggested by the regulatory
guidance...
Back to the Top
Dear wichittra,
1.The number of male and female subjects need not be equal
2.you can alter the food according to calorie value,percentage of
fat,protein and carbohydrate and more importantly the viscosity of the
food.
regards,
Muhiyideen
Back to the Top
I agree with Renu
You can change the breakfast menu while maintaining the amount of
calories. At one of the places I worked, we served fried chicken and
the same was consumed by volunteers with more compliance (though there
were rare cases of non-compliance). The breakfast was about 900-950
kcal. TIP: keep the breakfst cum calorie breakup with you alongwith a
calibrated weighing scale at time of serving breakfast. In case the
volunteer leaves some portion of the meal weigh the leftover food
immediately. If the subject had consumed over 700-725 kcal, you can
still consider dosing him/her despite the fact that some portion of
the meal was left out. All such instances should be well documented
and permission from CI / PI to go ahead with dosing should also be
documented.
Another advice: During my placement in Gujarat state I noted that the
volunteers had altogether different preferences for meals. So we
consulted our hospital dietitian and she came out with such wonderful
snacks/ meal menu, which catered to the taste of the local population
and also contained the required no of calories while maintaining the
proportion of fat: carbs: proteins etc. I suggest you consult a
dietitian too!
Another opinion: I strongly feel female volunteers may not be able to
eat such heavy meals. Since you are facing such problems, why don't
you keep all males in the study. Keeping females is not
mandatory...though recommended....
Dr. Gagandeep Singh
Sr. Consultant, Lifesciences
Cognizant Tech. Solns.
|
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 "Gender in BE" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)