Individual Bioequivalence Criterion

R., Hauck, W.W. et al., An individual bioequivalence criterion regnlatory considerations, Stat. Med. 19, 2821-2842, 2000 Meyer, M.C., United States Food and Drug Administration requirements for approval of generic drug products, J. Clin. Psychiatry 62 (Suppl. 5), 4-9, 2001 Temple, R., Policy developments in regulatory approval, Stat. Med. 21, 2939-3048, 2002 Gould, A.L, Substantial evidence of effect, J. Biopharm. Stat. 12, 53-77, 2002 Chen, M.L., Panhard, X., and Mentre, F, Evaluation by simulation of tests based on nonlinear mixed-effects models in pharmacokinetic interaction and bioequivalence cross-over clinical trials, Stat. Med. 24,1509-1524,2005 Bolton, S., Bioequivalence studies for levothy-roxine, AAPS J. 7, E47-E53, 2005. 

Bioequivalence Criterion and the Population Bioequivalence Criterion. The Individual Bioequivalence Criterion calls for a replicate study design, whereas the Population Bioequivalence Criterion does not involve a replicate study design, but a replicate crossover design or parallel design, which can also be used for this criterion. A replicate study design is one in which both the test and the reference drug products are administered to the same individuals on two separate occasions. 

Holder, D.J. Hsuan, F. A moment-trased criterion for determining individual bioequivalence. Drug Inf. J. 1995, 29 (3), 965-979. 

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