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Topic: Validation of a new spectroscopic method  (Read 1552 times)

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Offline wptmdoorn

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Validation of a new spectroscopic method
« on: May 14, 2014, 07:37:03 AM »
Hi all,

Recently we've been using the Jaffe reaction to determine the amount of creatinine found in urine. Now we want to validate and test this method to actually how precise, accurate, senstive and specifical it is. I have been doing different statistic calculations but I need some guidelines to actually make them worth using. The problem mostly is not the calculations and steps itself, I just need some guidelines on -what- to use and -when- to validate methods.

I have the following questions;
  • Which steps need to be followed to actually validate a method in a reasonable manner?
  • Which statistic tools/calculations can I use to test and validate my method?

Thanks in advance.

Offline marquis

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Re: Validation of a new spectroscopic method
« Reply #1 on: May 17, 2014, 08:50:01 PM »
It's a hard question to answer, because validations vary dramatically from industry to industry and
country to country.

For example, validation per ISO requirements may require an quality audit by certified auditers.
This can be quite expensive.  Best idea is to find the industry requirements and go from there.

Having said that, if you can find the method in a reference (for example, ASTM, USP, or other
similar reference) , you can probably find statistical data, too.  Even if the statistical data isn't there,
that the method is published can simplify validation requirements.

Hope this helps and good luck.

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