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The following message was posted to: PharmPK
Dear all
Has anyone experience with bioequivalence studies for 100mg tablet of
thioridazine? My main concern is about tolerability by the volunteers
of the hypotension it may cause. I remember years ago a
bioequivalence study (unfortunately I do not remember the drug) that
was reported in the FDA site that some healthy volunteers had cardiac
arrest and the decision was to perform the study with lower dosage form.
Many thanks for any help
Gilberto De Nucci
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The following message was posted to: PharmPK
Hi!
Surprisingly Thioridazine HCl (Sandoz) has got 3 RLDs - 25, 100 and
200mg tablets. In such a case you may not be allowed waiver for other
strengths by conducting single bioequivalence study. If you are
worried about tolerability of 100mg then you have 200mg also to be
worried about. I think it would be better to get some information
from FOI or you may consider writing to FDA. Since it is a safety
issue they (FDA) will be very willing to support you.
Good Luck!!!
Dr. Manoj K. Paruthi
Manager, R&D
Phone - +962 79 6961604
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