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One month after the last CMS dose, criteria for Risk and Injury were still present in respectively 14 (28%) and 1 (2%) of 50 evaluable patients.
For that reason, it seems necessary to analyze which sequences exceed the allowed offsite dose criteria prior to the core damage criterion.
The results show that the doses in CR, EAB and LPZ are acceptable compared with dose criteria in RG 1.183 and the differences between AST method and TID-14844 method are also discussed.
Other stated target dose criteria were vague.
Thirteen children identified as virological successes at M12 (VL < 1000 cp/mL) and 20 children as virological successes at M24 (VL < 400 cp/mL) were classified as non-adherent according to cumulative missed dose criteria but adherent according to current missed dose criteria.
However, the Gilbertson et al. study was conducted with hemodialysis patient data generated during 2008, and the ESA dose criteria do not reflect changes in ESA dosing that have occurred since 2011.
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Table 5 lists the target dose criterion stated for 97 dose investigation studies.
Many studies (40 of 97) do not pre-specify a target dose criterion.
As noted above, the algorithm deemed treatment that met the increased dose criterion to be not effective.
A target dose criterion could not be determined for a high proportion of studies, particularly for those studies developing orphan medicines.
However, neither Cranney nor Chung used a minimum dose criterion; nor did they require documentation of a therapeutic blood level in the treated group.
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