Table 2

Quality of medicines per API in included quality surveys, bioequivalence studies, accelerated biostability studies, laboratory assembled collections and case reports/MRA seizures

Medicine nameAccelerated biostability studiesBioequivalence studiesQuality surveysLaboratory assembled collectionsCase reports/MRA seizureTotal
NnFailure rate %NnFailure rate %NnFailure rate %NnFailure rate %NnFailure rate %Nn failedFailure rate %
Amikacin2245725.42245725.4
Cycloserine1495738.31505436.029911137.1
Doripenem600.000600.0
Ethambutol4250.011300.062310016.11110074110313.9
Ethionamide100.0861214.0871213.8
Gatifloxacin/Ciprofloxacin0065651006565100.0
Imipenem-Cilastatin600.000600.0
Isoniazid100.019700.014721429.616701428.5
Isoniazid-Ethambutol9777.85240.014964.3
Kanamycin8045.08045.0
Levofloxacin1612716.84125.01652817.0
Meropenem1800.0500.02300.0
Moxifloxacin4000.04000.0
Norfloxacin600.0600.0
Ofloxacin9555.61453121.4400.01583622.8
Prothionamide10000.010000.0
Pyrazinamide100.019500.0733658.9929657.0
Rifampicin100.024310041.2202533716.6226943719.3
Rifampicin- Isoniazid- Ethambutol9777.84400.0692637.71223327.0
Rifampicin-Isoniazid6350.026830.816931.8700.011100209157.2
Rifampicin-Isoniazid-Pyrazinamide3266.7832125.33912.61400.01392417.3
Rifampicin-Isoniazid-Pyrazinamide- Ethambutol23939.111121.810066.0900.0243177.0
Rifampicin-Isoniazid-Pyrazinamide- Ethambutol- Pyridoxine





100.0





100.0
Streptomycin6400.0221254.5861214.0
Total2368736.9108613612.5625587914.13812.667671007682117015.2
  • MRA, Medicines Regulatory Agency.