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Different regulatories follow different procedures for Scaled
And you can have a look for the following link for papers on SCABE:
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A partial list of references:
L. Tothfalusi, and L. Endrenyi. Limits for the scaled average
bioequivalence of highly variable drugs and drug products. Pharm. Res.
20: 382-389 (2003).
V. Karalis, P. Macheras, and M. Symillides. Geometric mean
ratio-dependent scaled bioequivalence limits with leveling-off
properties. Eur. J. Pharm. Sci. 26: 54-61.
S.H. Haidar, B. Davit, M.-L. Chen, et al. Bioequivalence approaches for
highly variable drugs and drug products. Pharm. Res.15: 237-241 (2008).
S.H. Haidar, F. Makhlouf, D.J. Schuirmann, et al. Evaluation of a
scaling approach for the bioequivalence of highly variable drugs. AAPS
J. 10: 450-454 (2008).
L. Endrenyi and L. Tothfalusi. Regulatory conditions for the
determination of bioequivalence of highly variable drugs. J. Pharm.
Pharm. Sci. 12: 138-149 (2009).
L. Tothfalusi, L. Endrenyi, and A. Garcia Areta. Evaluation of
bioequivalence for highly variable drugs with scaled average
bioequivalence. Clin. Pharmacokin. 48: 725-743 (2009).
L. Tothfalusi and L. Endrenyi. Sample sizes for designing bioequivalence
studies for highly variable drugs. J. Pharm. Pharm. Sci. 15: 73-84
V. Karalis, M. Symillides, and P. Macheras. On the leveling-off
properties of the new bioequivalence limits for highly variable drugs of
the EMA guideline. Eur. J. Pharm. Sci. 44: 497-505 (2011).
B.M. Davit, M.-L. Chen, D. Conner, et al. Implementation of a
reference-scaled average bioequivalence approach for highly variable
generic drug products by the US Food and Drug Administration. AAPS J.
14: 914-924 (2012).
University of Toronto
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