Medicine name | Accelerated biostability studies | Bioequivalence studies | Quality surveys | Laboratory assembled collections | Case reports/MRA seizure | Total | ||||||||||||
N | n | Failure rate % | N | n | Failure rate % | N | n | Failure rate % | N | n | Failure rate % | N | n | Failure rate % | N | n failed | Failure rate % | |
Amikacin | 224 | 57 | 25.4 | 224 | 57 | 25.4 | ||||||||||||
Cycloserine | 149 | 57 | 38.3 | 150 | 54 | 36.0 | 299 | 111 | 37.1 | |||||||||
Doripenem | 6 | 0 | 0.0 | 0 | 0 | 6 | 0 | 0.0 | ||||||||||
Ethambutol | 4 | 2 | 50.0 | 113 | 0 | 0.0 | 623 | 100 | 16.1 | 1 | 1 | 100 | 741 | 103 | 13.9 | |||
Ethionamide | 1 | 0 | 0.0 | 86 | 12 | 14.0 | 87 | 12 | 13.8 | |||||||||
Gatifloxacin/Ciprofloxacin | 0 | 0 | 65 | 65 | 100 | 65 | 65 | 100.0 | ||||||||||
Imipenem-Cilastatin | 6 | 0 | 0.0 | 0 | 0 | 6 | 0 | 0.0 | ||||||||||
Isoniazid | 1 | 0 | 0.0 | 197 | 0 | 0.0 | 1472 | 142 | 9.6 | 1670 | 142 | 8.5 | ||||||
Isoniazid-Ethambutol | 9 | 7 | 77.8 | 5 | 2 | 40.0 | 14 | 9 | 64.3 | |||||||||
Kanamycin | 80 | 4 | 5.0 | 80 | 4 | 5.0 | ||||||||||||
Levofloxacin | 161 | 27 | 16.8 | 4 | 1 | 25.0 | 165 | 28 | 17.0 | |||||||||
Meropenem | 18 | 0 | 0.0 | 5 | 0 | 0.0 | 23 | 0 | 0.0 | |||||||||
Moxifloxacin | 40 | 0 | 0.0 | 40 | 0 | 0.0 | ||||||||||||
Norfloxacin | 6 | 0 | 0.0 | 6 | 0 | 0.0 | ||||||||||||
Ofloxacin | 9 | 5 | 55.6 | 145 | 31 | 21.4 | 4 | 0 | 0.0 | 158 | 36 | 22.8 | ||||||
Prothionamide | 100 | 0 | 0.0 | 100 | 0 | 0.0 | ||||||||||||
Pyrazinamide | 1 | 0 | 0.0 | 195 | 0 | 0.0 | 733 | 65 | 8.9 | 929 | 65 | 7.0 | ||||||
Rifampicin | 1 | 0 | 0.0 | 243 | 100 | 41.2 | 2025 | 337 | 16.6 | 2269 | 437 | 19.3 | ||||||
Rifampicin- Isoniazid- Ethambutol | 9 | 7 | 77.8 | 44 | 0 | 0.0 | 69 | 26 | 37.7 | 122 | 33 | 27.0 | ||||||
Rifampicin-Isoniazid | 6 | 3 | 50.0 | 26 | 8 | 30.8 | 169 | 3 | 1.8 | 7 | 0 | 0.0 | 1 | 1 | 100 | 209 | 15 | 7.2 |
Rifampicin-Isoniazid-Pyrazinamide | 3 | 2 | 66.7 | 83 | 21 | 25.3 | 39 | 1 | 2.6 | 14 | 0 | 0.0 | 139 | 24 | 17.3 | |||
Rifampicin-Isoniazid-Pyrazinamide- Ethambutol | 23 | 9 | 39.1 | 111 | 2 | 1.8 | 100 | 6 | 6.0 | 9 | 0 | 0.0 | 243 | 17 | 7.0 | |||
Rifampicin-Isoniazid-Pyrazinamide- Ethambutol- Pyridoxine | 1 | 0 | 0.0 | 1 | 0 | 0.0 | ||||||||||||
Streptomycin | 64 | 0 | 0.0 | 22 | 12 | 54.5 | 86 | 12 | 14.0 | |||||||||
Total | 236 | 87 | 36.9 | 1086 | 136 | 12.5 | 6255 | 879 | 14.1 | 38 | 1 | 2.6 | 67 | 67 | 100 | 7682 | 1170 | 15.2 |
MRA, Medicines Regulatory Agency.