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. 2015 May 6;17(5):1312–1316. doi: 10.1208/s12248-015-9777-x

Table II.

Various Bioequivalence Guidelines in Japan

Guideline for bioequivalence studies of generic products http://www.nihs.go.jp/drug/be-guide(e)/Generic/GL-E_120229_BE.pdf
Guideline for bioequivalence studies of generic products for different strengths of oral solid dosage forms http://www.nihs.go.jp/drug/be-guide(e)/strength/GL-E_120229_ganryo.pdf
Guideline for bioequivalence studies for formulation changes of oral solid dosage forms http://www.nihs.go.jp/drug/be-guide(e)/form/GL-E_120229_shohou.pdf
Guideline for bioequivalence studies for different oral solid dosage forms http://www.nihs.go.jp/drug/be-guide(e)/GL-E_120229_zaikei.pdf