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The medicaments inside body analyses methodological design and opinion
From;    Author:Stand originally

One, the set basis that analyses a method:
⑴ takes seriously and make good document summary, arrange the job;
⑵ sufficient understanding treats the character that measures medicaments and condition of the existence inside body;
⑶ makes clear determining intent requirement;
⑷ lab condition.
2, the common step that the method builds:
⑴ with pure article undertake determining: With certain amount pure article undertake determining by protocol method. Get chroma and determine between response (if absorb,spend, color atlas peak height or area) relation, chroma linear limits, the most comfortable determine chroma, detect sensitivity, determining the most comfortable condition (time of PH, temperature, reaction) etc.
⑵ in order to pass rarefied treated blank sample undertakes determining;
After ⑶ blank sample adds a level determine: After certain amount standard items is being added in the sample such as hematic sample, undertake determining, get sample to reclaim rate data, examine biology sample has to determining jam-free etc.
Actual sample determines inside ⑷ body: The method that outside using system sometimes, establishs goes determining inside body when taking real kind, can get the verdict that gives a mistake. Reason should emphasize having the knowledge of certain level to the process inside medicaments body. Also use sometimes exclusive the strong, measure that already proved to apply to appearance of the fact inside body to determine and method serve as the gender contrast determine, examine with this the actual feasibility of establishs method.
3, methodological evaluation:
⑴ accuracy (Accuracy) : Determine of result and true value accord with degree. Commonly used reclaim rate (Recovery) numerical value reflects determining exact rate secondhand; Also can have relative idea through the method that with its he already established (ginseng example law) will try to mirror. Reclaim rate 100% good of course, but very inaccessible. Important is to determine every time should keep stable.
⑵ precision (Precision) : Determine the deviate degree of result and average. Determine an error is smaller, taller also to determining requirement (expenses is large) ; Inverse ratio of the existence between chroma and RSD value concerns, RSD can consider as in the method of 10% less than acceptability.
⑶ sensitivity (Sensitivity) : "A kind of method can detect the minimum that gives concerned compound " . Commonly used lowest detects be restricted (Limit Of Detection, LOD) or lowermost check are measured (Limit Of Quantification;LOQ) will express. LOD limits is in Ng(10-9g) ~ 10-18g.
⑷ is exclusive gender or alternative (Specificity Or Selectivity) : It is to point to determining signal (answer) it is to belong to be measured medicaments place is peculiar. If have interference,need to improve determine method or change appliance to have detached capacity (those who be like color atlas law is exclusive quality relatively absorb photometry to be tall) method or exclusive the method with stronger sex undertakes.
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