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Dear All,
I am seeking an opinion about conducting BE studies of Antiretrovirals
in healthy volunteers (single and combination drugs) as we are
requested by our sponsors to conduct those studies in our facility. I
am working as clinical pharmacologist in a CRO.
Thanks and Regards,
Dr.Padmavathi.V
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Dear Dr.Padmavathi,
I hope your question is regarding safety?
Even the antiretroviral drugs are very toxic drugs, severe adverse
events are reported in patients on long term therapy, but a single dose
in healthy volunteers is manageable (nausea and vomiting) if more
stand-by subjects are recruited for the study than the required sample
size for analysis.
With Regards,
V.Radhakrishna
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Dear All
regarding the question related to BE studies of Antiretrovirals, there
is no specific regulations about conducting BE for these agents and
hence they are treated same like other drugs. Still BE study is
designed depending on half-life and tmax of the drug and geometric
means and 90% confidence intervals for AUC and Cmax as an acceptance
criteria.
Regards
Isra' Admour, M.Sc Pharm
Regualtory Affairs Director
International Pharmaceutical Research Center (IPRC)
Tel: +962-6-5627651/52/48 (ext. 213)
PO Box 963166, Amman11196, Jordan
www.iprc.com.jo
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Hi Dr. Padmavathi,
You can have a look at the US FDA guideline on Fixed Dose Combination
and Co-Packaged Drug Products for Treatment of HIV (5/17/2004).
http://www.fda.gov/OHRMS/DOCKETS/98fr/04D-0228-GDL0001-6283dft.pdf
The guideline clearly outlines the procedure for the conduct of the
studies including number of subjects, study design and has a list of
acceptable and unacceptable combinations.
Hope this will be helpful
Regards
M.M. Ganesh
Senior Research Scientist
Ranbaxy Research Laboratories
New Delhi, INDIA
Web Page: www.geocities.com/ganaish/gans
Tel: 91-9891532434
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