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DOI: 10.1055/s-0031-1296638
Open Questions on Bioequivalence: What about the Time Interval between Two Consecutive Trials?
Publication History
Publication Date:
21 December 2011 (online)
Abstract
The interval between two different consecutive pharmacokinetic trials in the same healthy volunteers lasts traditionally 3 months, in compliance with the turnover of blood donations in volunteers. The above trials, in fact, mainly bioequivalence trials, involve pharmacokinetic measurements and relevant blood withdrawals, e. g. 400-500 ml. Operating guidelines do not give any suggestion about the above lapse of time between two consecutive trials.
An Italian Ministerial Decree (DM 122/98) requires the above period to last at least 6 months. This appears to be a unique more than a rare request in this field. In fact, it does not add anything to the quality of the trial and invades the field of competence of the ethics committees and virtually needs a national register of the volunteers to allow a check. This appears to be an additional open question on bioequivalence.