By Anonymous on Monday, July 30, 2001 - 11:47 am:
What is the accuracy and precision one should expect from an HPLC assay? I am used to methods that have 1 - 3% variability. In my current place of employment, our methods permit 15% variability.
By bill tindall on Monday, July 30, 2001 - 06:51 pm:
short term rsd's (within a day) for integrating a well behaved peak should be slightly better than 1%.
RSD's for the method might be anything depending on the nature of the steps and the skill in executing them.
15 % is sloppy work or a poor/difficult method, unless its some trace component.
By Anonymous on Tuesday, July 31, 2001 - 02:02 pm:
The 15% permissable at your place of work is probably related to the FDA guidance on validation of bioanalytical method validation. Like Bill said, this might be due to sloppy work, but that isn't always the case. You can find the guidance document at the following site:
http://www.fda.gov/cder/guidance/4252fnl.htm
By Anonymous on Tuesday, July 31, 2001 - 02:35 pm:
Why does the FDA allow 15% variability for bioanalytical methods when the instrumentation is capable of much better? My background is in the chemical industry where I am used to variability of 1 - 3%. I recently took a new job in the biotech industry and I am trying to decide whether or not to try and impliment methods with better accuracy and precision.
By Anonymous on Wednesday, August 1, 2001 - 04:10 am:
Two major sources of errors in the bioanalysis field are sample preparation such as SPE, protein precipitation and interference peaks. Instrumentation errors (injection, integration etc) usually play a minor role here. That's why a limit of 15 or 20% is set depending on sample concentration.
By Ana Guillén on Monday, August 6, 2001 - 09:14 am:
It depens on the concentration of analyte. There is a EMEA Draft (EMEA/CVMP/573/00-FINAL)where you can find answer to some of this questions.
httl://www.eudra.org.emea.html
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