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Updated: Jul 12, 2026
07:13
A Two-interval Forced-choice Task for Multisensory Comparisons
Published on: November 9, 2018
Open questions on bioequivalence: what about the time interval between two consecutive trials?
1I.P.A.S. S.A., Ligornetto, Switzerland. antonio.marzo@ipas-research.com
Arzneimittel-Forschung
|September 7, 2007
Summary
The traditional 3-month interval between pharmacokinetic trials is questioned by a 6-month requirement in Italy. This Italian regulation for bioequivalence trials may not enhance trial quality or volunteer safety.
Area of Science:
- Pharmacokinetics
- Clinical Trial Design
- Regulatory Science
Background:
- Consecutive pharmacokinetic trials in healthy volunteers traditionally have a 3-month interval.
- This interval aligns with blood donation turnover and involves significant blood withdrawal (400-500 ml).
- Current operating guidelines lack specific recommendations for inter-trial intervals.
Purpose of the Study:
- To examine the implications of a mandatory 6-month interval between pharmacokinetic trials.
- To evaluate the regulatory requirement imposed by the Italian Ministerial Decree (DM 122/98).
- To discuss the impact of this extended interval on bioequivalence trial design and volunteer management.
Main Methods:
- Review of traditional practices in pharmacokinetic trial scheduling.
- Analysis of the Italian Ministerial Decree (DM 122/98) concerning inter-trial intervals.
- Discussion of the scientific and ethical considerations related to extended volunteer participation intervals.
Main Results:
- The Italian DM 122/98 mandates a minimum 6-month interval, which is unusually long.
- This regulatory requirement is not based on scientific evidence for enhancing trial quality.
- The decree may overstep the purview of ethics committees and necessitate volunteer registration systems.
Conclusions:
- The 6-month interval requirement for pharmacokinetic trials in Italy appears arbitrary and potentially burdensome.
- This regulation raises questions about its scientific justification and impact on bioequivalence studies.
- Further discussion is needed regarding the necessity and oversight of such extended intervals in clinical research.
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