Transcription of 別添8 動物用医薬品等の承認申請資料のためのガイ …
1 vich GL1 vich GL2 vich GL10R vich GL11R vich GL18 vich GL39 vich GL40 vich GL27 vich GL25 vich GL26 vich GL3R vich GL4 vich GL5 vich GL8 vich GL17 vich GL45 vich GL33 90 vich GL31 ( vich GL37 ( ) vich GL22 ( ) vich GL32 ( ) vich GL23 ( ))
2 vich GL28R ADI vich GL36 VICHGL43 vich GL44 vich GL7 vich GL12 vich GL13 vich GL14 vich GL15 vich GL16 vich GL19 vich GL20 vich GL21 vich GL46 vich GL47 vich GL48 vich GL49 vich GL1 EU EU
3 Accuracy Precision Repeatability Intermediate Precision Specificity Detection Limit Quantitation Limit Linearity Range Robustness Analytical Procedure Specificity
4 Accuracy Trueness Precision Repeatability Intra-assay precision Intermediate precision Reproducibility Detection Limit Quantitation Limit Linearity Range Robustness vich GL2 vich GL1
5 Specificity Identification Critical Separation
6 Linearity Range 80 120 70 130 20 20 24 90
7 110 120 vich GL10R vich GL11R 100 120 Accuracy response factor Precision Repeatability 100 Intermediate
8 Precision Reproducibility Detection limit DL DL S S S Quantitation limit
