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Single and Multiple Dose Bioequivalence Studies for Oxycodone Extended Release 80 mg and 5 mg Tablet.

PRESENTED TO: BioPharma Services Inc.
PRESENTED BY: J. He, N. Gharavi, and F. Trabelsi

PURPOSE

Single and Multiple-Dose Bioequivalence Studies for Oxycodone Extended Release 80 mg and 5 mg Tablet – The oxycodone extended release (ER) tablet (OxyContin® by Purdue Pharma L.P) provides long therapeutic duration for pain relief. The requirements of bioequivalence (BE) trials for generic drug submission for FDA and TPD require single-dose studies only, while EMA requires both, a multiple-dose study with the highest strength to demonstrate BE at steady-state, as well as a single-dose study.

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