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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