Utility of in vitro release testing (IVRT) to assess ‘sameness’ of 1% clotrimazole creams for use as a biowaiver

AAPS Open

Table 3 VDC product dosing scheme

	VDC 1	VDC 2	VDC 3	VDC 4	VDC 5	VDC 6
Canesten® SA vs. itself (batch A — R_1Aand batch B — R_1B)
Run 1	R_1A	R_1B	R_1A	R_1B	R_1A	R_1B
Run 2	R_1B	R_1A	R_1B	R_1A	R_1B	R_1A
SA-marketed 1% CLZ generic creams (SA_n) vs. Canesten® SA (R₁)
Run 1	R₁	SA₁	SA₂	SA₃	SA₄	SA₅
Run 2	SA₁	SA₂	SA₃	SA₄	SA₅	R₁
Run 3	SA₂	SA₃	SA₄	SA₅	R₁	SA₁
Run 4	SA₃	SA₄	SA₅	R₁	SA₁	SA₂
Run 5	SA₄	SA₅	R₁	SA₁	SA₂	SA₃
Run 6	SA₅	R₁	SA₁	SA₂	SA₃	SA₄
1% CLZ creams (CA generic CA₁and extemporaneously prepared creams T₁and T₂) vs. relevant comparator products — Canesten® SA and CA (R₁and R₂)
Run 1	R₁	R₂	CA₁	T₁	T₂	R₁
Run 2	R₂	CA₁	T₁	T₂	R₁	R₂
Run 3	CA₁	T₁	T₂	R₁	R₂	CA₁
Run 4	T₁	T₂	R₁	R₂	CA₁	T₁
Run 5	T₂	R₁	R₂	CA₁	T₁	T₂