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The following message was posted to: PharmPK
Dear Members of pharma Pk,
since i am in india, it is tough enough to get bacon for our clinical
studies? can you recommand meal plan for high fat high calorie breakfast
for bioequivalence studies?..
With Regards,
M.Francis,
Research Scientist,
Quest Life Sciences,
Chennai
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The following message was posted to: PharmPK
Dear Francis,
It is tough to get bacon for the clinical studies in India.
The following you can used in place of bacon as per FDA
Quantity (gm) Energy (Kcal)
Chicken 60 gm 146
Whole Milk 240 mL 152
Hash Brown Potatoes 120 gm 162
Fried Eggs in butter* 2 medium 267
Bread Slices 2 large 160
Butter 8 gm 72
Total: 959 Kcal
Sanjeev Kumar
Research scientist
Ranbaxy Research Laboratories
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The following message was posted to: PharmPK
Klein et al. (J. Pharm. Pharmacol. 56, 605-610 [2004]) showed that
the composition of the standard FDA breakfast was very close to that
of a commercially available liquid meal.
I don't know if this is an acceptable replacement for regulatory
submissions but it may make life easier otherwise.
All the very best,
Bernard
Bernard Murray, Ph.D.
Senior Research Scientist, Drug Metabolism
Gilead Sciences
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The following message was posted to: PharmPK
Dear M.!
If you are not performing a study for the US-FDA or CAN-HPB, it's up
to you.
You may have a look at this thread:
http://forum.bebac.at/forum_entry.php?id=20
[This URL should end "? i d = 2 0" without the " and spaces - db]
best regards,
Helmut
--
Helmut Schuetz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna/Austria
tel/fax +43 1 2311746
http://BEBAC.at
Bioequivalence/Bioavailability Forum at http://forum.bebac.at
http://www.goldmark.org/netrants/no-word/attach.html
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Hi Bernard!
> Klein et al. (J. Pharm. Pharmacol. 56, 605-610 [2004]) showed that
> the composition of the standard FDA breakfast was very close to that
> of a commercially available liquid meal.
>
Yes, but only in caloric/lipid/carbohydrate/protein-breakdown ;-)
> I don't know if this is an acceptable replacement for regulatory
> submissions but it may make life easier otherwise.
>
The test meal should challenge the formulation not only based on it's
composition, but also by potential changes in gastric motility and
emptying.
I would suspect that a liquid meal would rather quickly leave the
stomach; there is nothing like the 2-4mm particle threshold observed
in chewed food.
After a short time the stomach is again in the fasted state, leaving
only the bioanalyst later on dealing with dispersed lipids in early
blood samples.
If an alternate meal is used, FDA wants not only matching their
standard meal in composition, but also in *viscosity* - whatever the
viscosity of fried bacon is ;-)
You may also have a look at
http://forum.bebac.at/forum_entry.php?id=20 for links to other
country's regulatory guidelines.
[This URL should end "? i d = 2 0" without the " and spaces - db]
best regards
Helmut
--
Helmut Schutz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna/Austria
tel/fax +43 1 2311746
http://BEBAC.at
Bioequivalence/Bioavailability Forum at http://forum.bebac.at
http://www.goldmark.org/netrants/no-word/attach.html
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