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 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.