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Dear All,
For BE study of suspension, should we pool all of suspension for
volunteers or use
the individual bottle for each subject?
Thankyou in advance for your information.
Srirat Kasiwong
Faculty of Pharmaceutical Sciences
Prince of Songkla University
Thailand
Hi Kasiwong,Back to the Top
Use individual bottles. Do not pool individual bottles in only one
large suspension.
It is a good idea to check the uniformity of content of the powder in
the bottles before the BE study.
When solid oral dosage forms, like tablets or capsules, are
administered the situation is similar. We do not grind all tablets in
one mass of powder. The manufacturing technology should be able to
produce individual dosing units that conform to the official
requirements (Pharmacopoeia). Those tolerances should be acceptable
differences between individual doses in a BE study.
radu
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Hello Srirat,
I would suggest to have individual bottles of suspension for each
subject. One bottle should be a single dose.
Your manufacturer will prepare one suspension and fill bottles as
unidoses. In your clinical protocol you will give the total dose and
rinse the bottles with additional water to ensure that all the dose is
given.
Best regards,
Frederic Doc (ex-Pfizer)
CEO, ADFINIS
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