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Hi Sirat
Sorry for the delayed response. I presume you may have completed the
study, but we can surely discuss the issue for our knowledge.
Regarding your questions... answers are placed below each question...
1. Can we continue the subjects in the study?
Yes - continue. I read in one of your posts that food does not have
significant impact on the absorption of drug, so i think its ok to
continue.
2. If we continue them in study (for period 2), for the subjects who
did not consume full meal, should we give equal amount of meal what
they had consumed in period 1?
No - give them the entire meal as in protocol. In my past experience,
if a subject did not complete full meal in period 1 and was not
discontinued, the same subject was given complete meal as per protocol
in period 2.
3. If yes, will it violate ethics? suppose one of the subject is
hungry and he wants to consume full meal though he did not consume
full meal in period 1. (not applicable here)
4. Suppose in period 2, we give full meal to all subjects and all of
them consume full meal and study passes. Can we justify regulatory
bodies stating that food doses not have any effect on medicine
absorption.It will be helpful to give comments.
I also noticed that there was a post regarding withdrawal of subject
at any time if subject vomits - my opinion is: In case your drug is
not a "sustained/delayed" release, then for sure you can make your own
"cut off" time (i.e. time beyond which if a person vomits, he can be
kept in study) - tmax and t-half should help in calculation of the
same. For delayed release, the cut off point can be as long as 24
hours depending on nature of the drug!!!
Hope that helps. Ping me if you have any questions.
Dr. Gagandeep SinghSr. Consultant, Cognizant Tech Soln.
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The following message was posted to: PharmPK
On the subject of size of meal in BE or BA studies Dr Singh wrote:
2. If we continue them in study (for period 2), for the subjects who
did not consume full meal, should we give equal amount of meal what
they had consumed in period 1?
No - give them the entire meal as in protocol. In my past experience,
if a subject did not complete full meal in period 1 and was not
discontinued, the same subject was given complete meal as per protocol
in period 2.
My feeling is that this advice works most of the time because portal
blood flow, the main element in the first pass effect, is activated by
a relatively modest amount of food. Therefore once the subject has
consumed a quite modest meal there is little change when the size of
meal increases. However, I do regard Singh's advice as putting the
protocol procedural cart before the scientifically logical horse, so I
would require the volunteer to have the same meal each time. The main
reason is that I would not know how to interpret a difference should
one occur. You either have to reject the difference as being
conveniently due to chance, or you have to admit you made a bad
assumption that the two meals were comparable or you have to do
another study to explain the difference. In that last case you would
have to be prepared to explain to your director the big hole that has
appeared in your budget and the delays ...
My advice would be to have a suitable and adequate choice of specified
meals that the volunteer can choose from and that they must consume
the same meal on all occasions. If they then fail to comply and
actually take meals that are not comparable in amount and lipid
content, their data would be recorded for completeness but not
included in the group analysis.
Andrew Sutton
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The following message was posted to: PharmPK
Another effect to be considered is gastric emptying time, which is
somewhat
proportional to calories consumed.
Walt Woltosz
Chairman & CEO
Simulations Plus, Inc. (NASDAQ: SLP)
42505 10th Street West
Lancaster, CA 93534-7059
U.S.A.
http://www.simulations-plus.com
E-mail: walt.-at-.simulations-plus.com
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