Studies of generic imatinib evaluating the pharmacologic properties and bioequivalence
| Authors . | Country . | Study type . | Sample size . | Results and comments . |
|---|---|---|---|---|
| Grillo et al10 | Argentina | In vitro | NA | Original imatinib was produced in β-crystal form while generics mostly in α-crystal form which was observed as less stable than β-form in room temperature |
| Yokoo et al11 | Japan | In vitro | NA | Comparable OS rates with original and generic imatinib in CML cell lines |
| Parrillo-Campiglia et al19 | Uruguay | In vivo | 30 | Mean test/reference ratios for AUC and Cmax:95% and 97% (CI: 90%), respectively |
| Ostrowicz et al18 | Poland | In vivo | 80 | Comparable Tmax, Cmax, AUC0-24 values with original and generic imatinib. Acceptable therapeutic limits (90-111.11%) for generic product |
| Malhotra et al14 | India | In vivo | 131 | Comparable mean imatinib trough levels with original imatinib (n = 84) and generic (n = 47; P = .079) |
| Ostojic et al12 | Croatia | In vivo | 24 | 75% of branded and 89% and 100% of generic pts achieved IPC ≥ 1000 ng/mL |
| Arora et al17 | India | In vivo | 42 | Mean test/reference Cmax and AUC0-24 ratios: 99% and 99.2%, respectively (P = .78 and P = .99; CI: 90%) |
| Natarajan et al13 | India | In vivo | 206 | All patients (original = 130, generics = 76) reached plasma concentration above 1000 ng/ml (P = .964). |
| Authors . | Country . | Study type . | Sample size . | Results and comments . |
|---|---|---|---|---|
| Grillo et al10 | Argentina | In vitro | NA | Original imatinib was produced in β-crystal form while generics mostly in α-crystal form which was observed as less stable than β-form in room temperature |
| Yokoo et al11 | Japan | In vitro | NA | Comparable OS rates with original and generic imatinib in CML cell lines |
| Parrillo-Campiglia et al19 | Uruguay | In vivo | 30 | Mean test/reference ratios for AUC and Cmax:95% and 97% (CI: 90%), respectively |
| Ostrowicz et al18 | Poland | In vivo | 80 | Comparable Tmax, Cmax, AUC0-24 values with original and generic imatinib. Acceptable therapeutic limits (90-111.11%) for generic product |
| Malhotra et al14 | India | In vivo | 131 | Comparable mean imatinib trough levels with original imatinib (n = 84) and generic (n = 47; P = .079) |
| Ostojic et al12 | Croatia | In vivo | 24 | 75% of branded and 89% and 100% of generic pts achieved IPC ≥ 1000 ng/mL |
| Arora et al17 | India | In vivo | 42 | Mean test/reference Cmax and AUC0-24 ratios: 99% and 99.2%, respectively (P = .78 and P = .99; CI: 90%) |
| Natarajan et al13 | India | In vivo | 206 | All patients (original = 130, generics = 76) reached plasma concentration above 1000 ng/ml (P = .964). |
CI, confidence interval; NA, not available.