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I'd like to know if there is any recommendation about the risperidone
bioequivalence.
Thinking about adverse events of 3 mg dosage, is there any
recommendation to assay only the 1 mg tablet wavering the 2 and 3 mg
dosages?
Regards and thanks,
Raquel Lima
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USFDA recommends BE studies with 1mg dose of risperidone for safety
reasons...
Cordially,
Dr. Renu Jain
Research Associate
Clinical Research & Regulatory Affairs
Torrent Research Centre,
Village: Bhat, Dist: Gandhinagar - 382 428
Desk: +91 79 23969100, ext. 297
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Dear Raquel,
Generally, BE studies are carried out with the highest dosage and
biowaiver are claimed to the lowest dosages. The Brazilian BE
Guidance doesn't say anything about situations when the highest
dosage presents adverse effects, so you may consider BE study with
the highest dosage (3mg) and dissolution profile to the others (2 and
1mg).
Regards,
Daniel Rossi de Campos
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The following message was posted to: PharmPK
Hi Raquel, if it's for the FDA you'll also want to measure the 9-hydroxy
metabolite. Cheers,
David Dubins
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The following message was posted to: PharmPK
Correction, the FDA does not require the hydroxy metabolite for
Risperidone. Parent only.
Nick V
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FDA does not ask for 9-OH measurement for risperidone.
OGD recommends to measure only the parent drug.
Cordially,
Dr. Renu Jain
Research Associate
Clinical Research & Regulatory Affairs
Torrent Research Centre,
Village: Bhat, Dist: Gandhinagar - 382 428
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