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Anyone has experience with bioequivalence of risedronate active?
bicompartmental model: plasma and bone. two half-lives(long and short).
Bioequivalence with the first t1 / 2? or the second T1 / 2?
Regards,
Bernardino Silva
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The following message was posted to: PharmPK
Dear Mr. Bernardino Silva,
Single-dose, two-treatment, two-period crossover bioequivalence studies
with the following doses 35 mg and 150 mg is generally recommended. You
may also conduct a parallel design study due to its long half life.
Truncated AUC at 72 hours is also advisable.
Bioanalytical estimation of risedronate in plasma is adequate.
You can go for biowaiver for invivo testing of the following doses 5mg,
30mg and 75 mg based on proportional similarity of the formulations
across all strengths and acceptable in vitro dissolution testing of all
strengths.
Regards,
Dr.S.Gunasakaran,MBBS,MD
Medical Affairs.
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