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Table 2 Average bioequivalence among 3 randomly-selected generic products and reference product of 14 immediate-release, non-combinational, oral drugs

From: Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs

Drug

AUCT

AUCI

Cmax

Amlodipine

MSR 0.021, CV 14.6%

MSR 0.020, CV 14.2%

MSR 0.027, CV 16.5%

 Generic a vs Reference (54)

98.24% (93.76–102.94)

97.84% (93.48–102.41)

96.735% (91.75–102.00)

 Generic b vs Reference (54)

96.61% (92.20–101.23)

95.83% (91.56–100.30)

94.578% (89.699–99.72)

 Generic c vs Reference (53)

98.95% (94.39–103.72)

98.14% (93.72–102.76)

94.569% (89.645–99.76)

 Generic a vs Generic b (55)

102.34% (97.71–107.19)

102.70% (98.16–107.47)

101.71% (96.51–107.19)

 Generic b vs Generic c (54)

96.90% (92.56–101.63)

97.11% (92.78–101.64)

99.84% (94.69–105.27)

 Generic a vs Generic c (54)

99.25% (94.72–104.00)

99.76% (95.31–104.41)

101.498% (96.26–107.02)

Amoxicillin

MSR 0.012, CV 11.0%

MSR 0.011, CV 10.5%

MSR 0.037, CV 19.4%

 Generic a vs Reference (49)

100.68% (97.01–104.49)

100.48% (96.97–104.12)

98.87% (92.63–105.53)

 Generic b vs Reference (49)

107.45% (103.53–111.52)

106.92% (103.19–110.79)

109.20% (102.30–116.55)

 Generic c vs Reference (49)

104.99% (101.16–108.96)

104.78% (101.12–108.58)

111.32% (104.29–118.82)

 Generic a vs Generic b (49)

93.98% (90.70–97.38)

93.95% (90.67–97.35)

90.54% (84.83–96.65)

 Generic b vs Generic c (49)

101.04% (98.48–105.73)

101.93% (98.36–105.62)

98.10% (91.90–104.71)

 Generic a vs Generic c (49)

95.89% (92.55–99.37)

95.76% (92.41–99.23)

88.82% (83.21–94.80)

Atenolol

MSR 0.037, CV 19.4%

MSR 0.036, CV19.2%

MSR 0.055, CV 23.8%

 Generic a vs Reference (48)

105.84% (99.08–113.05)

105.52% (98.88–112.61)

106.46% (98.24–115.37)

 Generic b vs Reference (48)

103.12% (96.54–110.14)

102.71% (96.25–109.61)

103.10% (95.14–111.73)

 Generic c vs Reference (48)

111.87% (104.73–119.49)

111.41% (104.41–118.90)

106.58% (98.35–115.49)

 Generic a vs Generic b (48)

102.64% (96.09–109.63)

102.74% (96.27–109.64)

103.26% (95.29–111.90)

 Generic b vs Generic c (48)

92.18% (86.30–98.46)

92.19% (86.39–98.38)

96.74% (89.27–104.84)

 Generic a vs Generic c (48)

94.61% (88.58–101.06)

94.71% (88.75–101.08)

99.89% (92.18–108.25)

Cephalexin

MSR 0.008, CV 8.9%

MSR 0.008, CV 8.9%

MSR 0.040, CV 20.3%

 Generic a vs Reference (32)

99.46% (95.77–103.29)

95.50% (92.98–99.16)

107.53% (98.73–117.10)

 Generic b vs Reference (32)

101.43% (97.67–105.34)

101.18% (97.45–105.06)

95.11% (87.33–103.58)

 Generic c vs Reference (32)

98.65% (94.99–102.41)

98.44% (94.81–102.21)

105.52% (96.89–114.92)

 Generic a vs Generic b (32)

94.39% (90.91–98.00)

94.36% (90.88–97.97)

113.06% (103.81–123.13)

 Generic b vs Generic c (32)

102.79% (99.99–106.72)

102.86% (99.07–106.80)

90.13% (82.76–98.16)

 Generic a vs Generic c (32)

97.02% (93.44–100.73)

97.06% (93.48–100.77)

101.90% (93.57–110.98)

Ciprofloxacin

MSR 0.012, CV11.0%

MSR 0.012, CV 11.0%

MSR 0.020, CV14.2%

 Generic a vs Reference (41)

93.40% (89.67–97.29)

92.99% (89.28–96.86)

94.20% (89.37–99.29)

 Generic b vs Reference (41)

98.38% (94.45–102.47)

97.51% (93.62–101.57)

92.92% (88.15–97.94)

 Generic c vs Reference (41)

101.77% (97.71–106.01)

101.37% (97.32–105.59)

103.39% (98.09–108.98)

 Generic a vs Generic b (41)

94.94% (91.15–98.89)

95.36% (91.55–99.33)

101.38% (96.18–106.86)

 Generic b vs Generic c (42)

91.78% (88.11–95.60)

91.74% (88.07–95.55)

91.11% (86.44–96.04)

 Generic a vs Generic c (41)

96.83% (93.01–100.81)

96.39% (92.59–100.35)

90.16% (85.60–94.97)

Clarithromycin

MSR 0.060, CV 24.9%

MSR 0.057, CV 24.2%

MSR 0.100, CV 32.4%

 Generic a vs Reference (48)

96.40% (88.64–104.85)

96.91% (89.30–105.17)

93.85% (84.22–104.60)

 Generic b vs Reference (47)

102.52% (94.18–111.60)

103.61% (95.39–112.54)

96.28% (86.29–107.42)

 Generic c vs Reference (48)

89.22% (82.04–97.04)

89.83% (82.77–97.49)

87.74% (78.73–97.78)

 Generic a vs Generic b (47)

93.97% (86.32–102.29)

93.42% (86.01–101.48)

96.98% (86.92–108.21)

 Generic b vs Generic c (47)

115.23% (105.85–125.43)

115.70% (106.51–125.68)

109.97% (98.56–122.70)

 Generic a vs Generic c (48)

108.05% (99.35–117.51)

107.88% (88.41–117.08)

106.97% (95.98–119.21)

Diclofenac

MSR 0.023, CV 15.3%

MSR 0.022, CV 14.7%

MSR 0.129, CV 37.1%

 Generic a vs Reference (67)

100.03% (95.74–104.52)

100.19% (96.04–104.52)

86.61% (78.08–96.08)

 Generic b vs Reference (68)

99.80% (95.54–104.24)

99.77% (95.68–104.05)

92.48% (83.43–102.51)

 Generic c vs Reference (68)

103.74% (99.32–108.36)

104.01% (99.74–108.47)

86.46% (78.00–95.83)

 Generic a vs Generic b (68)

101.38% (97.06–105.89)

101.50% (97.33–105.85)

95.64% (86.28–106.01)

 Generic b vs Generic c (69)

96.38%(92.30–100.64)

96.06% (92.14–100.14)

107.01% (96.61–118.52)

 Generic a vs Generic c (68)

96.71% (92.59–101.01)

96.56% (92.59–100.70)

100.79% (90.93–111.72)

Ibuprofen

MSR 0.012, CV 10.9%

MSR 0.008, CV 9.1%

MSR 0.026, CV 16.3%

 Generic a vs Reference (27)

106.31%(101.06–111.83)

104.65% (100.30–109.19)

101.67% (94.30–109.62)

 Generic b vs Reference (25)

105.48% (100.05–111.20)

102.94% (98.48–107.59)

113.00% (104.47–122.23)

 Generic c vs Reference (26)

106.30% (100.95–111.94)

105.69% (101.21–110.36)

89.11% (82.52–96.22)

 Generic a vs Generic b (26)

102.27% (97.11–107.69)

103.13% (98.76–107.69)

92.17% (85.36–99.53)

 Generic b vs Generic c (26)

98.38% (93.418–103.60)

96.53% (92.44–100.80)

126.47% (117.11–136.57)

 Generic a vs Generic c (27)

99.87% (94.94–105.06)

98.87% (94.78–103.16)

114.12% (105.85–123.04)

Fluconazole

MSR 0.004, CV 6.3%

MSR 0.004, CV 6.3%

MSR 0.006, CV 7.8%

 Generic a vs Reference (26)

101.33% (98.34–104.42)

102.23% (99.21–105.35)

106.99% (103.13–110.99)

 Generic b vs Reference (25)

101.06% (98.01–104.21)

101.39% (98.33–104.55)

109.79% (105.75–113.99)

 Generic c vs Reference (25)

105.66% (102.47–108.94)

106.07% (102.86–109.36)

109.00% (104.98–113.17)

 Generic a vs Generic b (25)

100.38% (97.35–103.50)

100.39% (97.36–103.52)

97.59% (93.99–101.32)

 Generic b vs Generic c (25)

95.65% (92.77–98.63)

96.21% (93.31–99.21)

100.73% (97.01–104.58)

 Generic a vs Generic c (25)

96.01% (93.12–99.00)

96.59% (93.68–99.60)

98.30% (94.67–102.06)

Metformin

MSR 0.019, CV 13.8%

MSR 0.019, CV 13.8%

MSR 0.027, CV 16.5%

 Generic a vs Reference (48)

93.19% (88.89–97.69)

92.44% (88.17–96.91)

93.05% (87.96–98.44)

 Generic b vs Reference (48)

97.70% (93.19–102.42)

97.31% (92.82–102.01)

98.45% (93.06–104.15)

 Generic c vs Reference (49)

96.06% (91.68–100.66)

95.51% (91.15–100.08)

95.07% (89.92–100.52)

 Generic a vs Generic b (49)

100.80% (97.76–103.94)

95.06% (90.72–99.61)

94.41% (89.298–99.82)

 Generic b vs Generic c (49)

95.60% (92.71–98.57)

102.25% (97.61–107.17)

104.15% (98.50–110.11)

 Generic a vs Generic c (49)

96.36% (93.46–99.36)

97.23% (92.79–101.88)

98.33% (93.00–103.96)

Metronidazole

MSR 0.003, CV 5.5%

MSR 0.003, CV 5.5%

MSR 0.010, CV 10.0%

 Generic a vs Reference (28)

108.73% (106.05–111.48)

108.96% (106.28–111.72)

109.47% (104.60–114.58)

 Generic b vs Reference (27)

99.569% (97.07–102.14)

99.82% (97.31–102.39)

97.60% (93.17–102.24)

 Generic c vs Reference (28)

97.439% (95.04–99.90)

97.46% (95.06–99.92)

100.53% (96.05–105.22)

 Generic a vs Generic b (27)

109.349% (106.60–112.17)

109.32% (106.57–112.14)

111.57% (106.50–116.88)

 Generic b vs Generic c (27)

102.05% (99.49–104.68)

102.29% (99.72–104.93)

96.95% (92.55–101.56)

 Generic a vs Generic c (28)

111.59% (108.84–114.41)

111.81% (109.05–114.63)

108.90% (104.05–113.98)

Omeprazole

MSR 0.035, CV 18.9%

MSR 0.035, CV 18.9%

MSR 0.066, CV 26.1%

 Generic a vs Reference (74)

97.49% (92.62–102.62)

97.44% (92.57–102.56)

90.57% (84.41–97.17)

 Generic b vs Reference (73)

96.21% (91.37–101.30)

97.05% (92.17–102.19)

84.85% (79.04–91.08)

 Generic c vs Reference (74)

98.14% (93.24–103.30)

98.09% (93.19–103.25)

87.82% (81.85–94.23)

 Generic a vs Generic b (73)

101.33% (96.24–106.70)

100.34% (95.30–105.66)

106.59% (99.30–114.4)

 Generic b vs Generic c (74)

97.59% (92.71–102.72)

98.55% (93.63–103.73)

96.35% (89.80–103.37)

 Generic a vs Generic c (74)

99.34% (94.38–104.56)

99.33% (94.37–104.55)

103.13% (96.12–110.64)

Paracetamol

MSR 0.008, CV 8.8%

MSR 0.008, CV 9.1%

MSR 0.031, CV 17.6%

 Generic a vs Reference (40)

91.57% (88.62–94.62)

91.81% (88.76–94.96)

104.99% (98.30–112.14)

 Generic b vs Reference (38)

99.69% (96.35–103.14)

99.66% (96.22–103.22)

103.48% (96.71–110.73%)

 Generic c vs Reference (39)

97.95% (94.71–101.29)

97.86% (94.53–101.30)

101.17% (94.63–108.15)

 Generic a vs Generic b (38)

100.01% (96.71–103.43)

100.26% (96.85–103.79)

101.76% (95.18–108.78)

 Generic b vs Generic c (38)

94.29% (91.18–97.52)

94.29% (91.09–97.62)

102.27% (95.57–109.43)

 Generic a vs Generic c (39)

102.11% (98.74–105.60)

102.46% (98.97–106.07)

104.11%(97.38–111.30)

Ranitidine

MSR 0.021, CV 14.6%

MSR 0.020, CV 14.2%

MSR 0.047, CV 21.9%

 Generic a vs Reference (70)

102.68% (98.57–106.96)

102.43% (98.43–106.59)

105.26% (99.02–111.89)

 Generic b vs Reference (71)

102.54% (98.47–106.79)

102.50% (98.52–106.64)

98.21% (92.43–104.34)

 Generic c vs Reference (72)

101.84% (97.82–106.02)

101.81% (97.89–105.89)

104.51% (98.40–111.00)

 Generic a vs Generic b (70)

100.30% (96.38–104.37)

100.29% (96.37–104.37)

107.89% (101.49–114.69)

 Generic b vs Generic c (71)

100.27% (96.38–104.31)

100.34% (96.45–104.39)

93.64% (88.13–99.49)

 Generic a vs Generic c (70)

100.30% (96.38–104.38)

100.38% (96.45–104.46)

100.66% (94.70–107.01)

  1. AUCT is the area-under-the-concentration-time curve to last measured concentration. AUCI is AUC extrapolated to infinity. Cmax is maximum concentration. Data represent geometric mean ratios and unadjusted 90% confidence intervals. The number of subjects analyzed in each comparison is presented between parentheses in the first column. MSR is mean square residual from analysis of variance (ANOVA). CV is intra-subject coefficient of variation calculated as 100 x (exp(MSR)-1)0.5. Confidence intervals that cross the 80.00%–125.00% bioequivalence limits are bolded