Qualitative assay
47
A method of analysis with two possible outcomes.
48
49
PDE5 Inhibitors
50
For the purposes of this SMPR: PDE5 inhibitors are defined as avanafil, lodenafil carbonate,
51
mirodenafil, sildenafill, tadalafil, udenafil, or vardenafil; or any of their analogs. Refer to the
52
Supplemental List of Known PDE5 Inhibitors
(as of July 2014) at the AOAC website (address and
53
hyperlink to be inserted).
54
55
Selectivity Study
56
A study designed to demonstrate that a candidate method does not detect non-target compounds,
57
and at the same time, demonstrate a candidate method’s ability to detect the different types of
58
PDE5 inhibitors (as a minimum the target panel provided in Annex II).
59
60
4.
Method Performance Requirements
:
61
Table 1: Matrix Dependent Criteria
62
63
64
65
66
67
68
69
Parameter
Parameter Requirements
Target Test
Concentration
Minimum Acceptable
Results
Single Laboratory Validation
POD @ low
concentration
Minimum of 33 replicates per
matrix type, spiked at or below the
designated low level target test
concentration.
100 ppm
90% POD
§
POD @ high
concentration
Minimum of 5 replicates per
matrix type spiked at 10x the
designated low level target test
concentration.
10 x low conc.
100% correct analyses
are expected per
matrix type
‡
POD @ zero
concentration
Minimum of 5 replicates per
matrix type.
0 ppm
Multi -Laboratory
Validation
LPOD
Use Appendix N: ISPAM Guidelines
for Validation of Qualitative Binary
Chemistry Methods.
low
concentration
≥ 0.85
§
10 x low conc.
≥ 0.95
§
LPOD
(0)
0 ppm
≤ 0.05
§
Note: LPOD and LPOD
(0)
are not required for Single Laboratory Validations.
‡
100% correct analyses are expected. Some aberrations may be acceptable if the aberrations are
investigated, and acceptable explanations can be determined and communicated to method users.
§
95% confidence interval
