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Table 1 Study design

From: Lipodox® (generic doxorubicin hydrochloride liposome injection): in vivo efficacy and bioequivalence versus Caelyx® (doxorubicin hydrochloride liposome injection) in human mammary carcinoma (MX-1) xenograft and syngeneic fibrosarcoma (WEHI 164) mouse models

Group no. Dose groups Doses (mg/kg) Concentrations (mg/mL) Dose volume (mL/kg) No. of animals
a. Treatment groups for the syngeneic fibrosarcoma tumour efficacy study
 1 Placebo Nil Nil 4.5 15
 2 SPIL DXR HCl liposome injection 9.0 2.0 4.5 11
 3 Reference DXR HCl liposome injection 9.0 2.0 4.5 15
 Total number 41
b. Treatment groups for the human mammary carcinoma xenograft efficacy study
 1 Placebo Nil Nil 10.0 10
 2 SPIL DXR HCl liposome injection 1.5 0.6 2.5 10
 3 3.0 0.6 5.0 10
 4 6.0 0.6 10.0 10
 5 Reference DXR HCl liposome injection 1.5 0.6 2.5 10
 6 3.0 0.6 5.0 10
 7 6.0 0.6 10.0 10
 Total number 70
Group no. Dose groups Doses (mg/kg) Concentrations (mg/mL) Dose volume (mL/kg) Time point (hour) No. of animals per time point
c. Study groups for the syngeneic fibrosarcoma tumour bioequivalence study
 1 SPIL DXR HCl liposome injection 5 1 5 0.08 12
0.5 12
3 12
5 12
8 12
24 12
48 12
96 12
168 12
240 12
 2 Reference DXR HCl liposome injection 5 1 5 0.08 12
0.5 12
3 12
5 12
8 12
24 12
48 12
96 12
168 12
240 12
Total number 240
  1. Abbreviations: DXR doxorubicin, HCl hydrochloride, SPIL Sun Pharmaceutical Industries Ltd.