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Dear all
As a matter of curiosity, is it possible to conduct a partial replicate
(RTR) parallel BE study rather than crossover study for a drug which is
highly variable and has a long half life so as to establish
bioequivalence? I have not found any reference regarding partial
replicate "parallel" BE study design. All the references suggest a
partial replicate "crossover" BE study design. Kindly suggest whether
such a BE study design is possible.
Regards
Raghuram Chimata M Pharm
Manager - Medical Services
Office No. 5119, 5th Floor, D-Wing,
Oberoi Garden Estates,
Chandivali, Andheri (E),
Mumbai 400072.
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The following message was posted to: PharmPK
If the drug has a long half-life then it is not necessary to undertake a
study with partial replication. A parallel-design investigation with
two arms, R and T, is sufficient. The third (R) arm would provide
information in a crossover study about the within-subject variation of
the reference product. In a parallel-design investigation, this
information can not be obtained.
Laszlo Endrenyi
University of Toronto
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