Batch Precision And Aclofen Case Analysis
Within Batch Precision and Accuracy for Baclofen Nominal Concentration (ng/mL) LLOQ QC LQC MQC1 MQC2 HQC QC# 20.759 % Accuracy 60.171 % Accuracy 110.406 % Accuracy 506.451 % Accuracy 750.297 % Accuracy 19 19.572 94.28 59.161 98.32 106.354 96.33 485.214 95.81 732.116 97.58 20 20.470 98.61 60.615 100.74 106.350 96.33 478.472 94.48 739.915 98.62 21 19.717 94.98 58.658 97.49 105.322 95.40 482.899 95.35 734.087 97.84 22 19.788 95.32 59.053 98.14 107.084 96.99 481.018 94.98 736.005 98.10 23 19.818 95.47 59.280 98.52 106.976 96.89 478.309 94.44 734.365 97.88 24 19.826 95.50 59.813 99.40 107.306 97.19 488.846 96.52 739.547 98.57 Mean 19.8652 59.4300 106.5653 482.460 736.0058 S.D. 0.31095 0.69049 0.72431 4.09323 3.14091 C.V.% 1.57 1.16 0.68 0.85 0.43 …show more content…
1.15585 1.29561 8.84900 11.47416 C.V.% 1.89 1.18 1.71 1.53 % Nominal 101.74 99.06 102.41 100.25 N 6 6 6 6 Recovery The mean overall recovery of Baclofen was 68.98% with a precision range of 1.31% to 9.70%. The mean recovery of internal standard Baclofen d4 was 69.31% with a precision ranging from 3.17% to 7.79%. Recovery of Baclofen from Human Plasma LQC Response MQC2 Response HQC Response Extracted QC Non Extracted QC Extracted QC Non Extracted QC Extracted QC Non Extracted QC LQC (19-24) LQC(01-06) MQC2 (19-24) MQC2(01-06) HQC(19-24) HQC(01-06) 15854 18425 108932 173808 169921 237625 13754 17998 124540 167729 163087 241625 13705 17375 102897 168326 167543 238566 12588 18846 111066 169105 164131 246917 14014 19071 93004 169214 174716 240865 13120 19279 104781 168300 158808 248580 Mean 13839.2 18499.0 107536.7 169413.7 166367.7 242363.0 S.D. 1113.37 717.75 10429.14 2222.91 5596.72 4450.72 C.V.(%) 8.05 3.88 9.70 1.31 3.36 1.84 N 6 6 6 6 6 6 % Recovery 74.81 63.48 68.64 Overall Recovery of Baclofen from Human Plasma Mean 68.98 S.D. 5.675 % Difference 11.33 N 3 Recovery of Baclofen d4 from Human
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719 Words | 3 PagesFifteen year old Lewis Blackman died after a minimally invasive surgery. The cause of death was due to perforated bowel caused by ketorolac, a highly potent non-steroidal anti-inflammatory to treat pain and inflammation and for its potential for stomach ulceration. As I read the case, I noticed the following system failures that lead to this sentinel event. First, ketorolac has a black box warning “not to be used in pediatric patients.” 1 A black box warning is the strictest warning put in the labeling of prescription drugs by the Food and Drug Administration when there is reasonable evidence of an association of a serious hazard with the drug.
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