By Rose on Monday, April 9, 2001 - 12:26 pm:
I work for a small pharmaceutical laboratory that performs research on transdermal patches. We are interested in starting a stability program and would like to know if someone can suggest where to find information on this subject or courses that are available on this subject.
Some information we are interested in is:
-FDA guidelines on how large of a sample size is needed for stability testing
-storage conditions for the samples
-recommended stability software for projecting shelf life
If you have any information on this subject, please let me know.
Thanks-Rose e-mail:rlobello@dermatrends.com
By Anonymous on Monday, April 9, 2001 - 02:46 pm:
www.fda.gov
By srinivas on Saturday, August 11, 2001 - 10:57 am:
in transdermal patches the drug and the polymer are very important. the drug content and the polymer nature have to be studied. the release studies will be more useful than the assay of the patch. it is better to do real time stability for such delivery sytems. accelarated stability will not predictable.
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