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Validation of a bioanalytic method

http://www.chromforum.org/viewtopic.php?t=21588

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Validation of a bioanalytic method

Posted: Thu Dec 27, 2012 4:08 pm
by montana
Hi ,

For Validation of a bioanalytical method ' determination of creatinine in plasma by HPLC-DAD,
Can you plz tell me what guide i have to follow, or how i can get an Excel spreadsheet for the validation .

BR

Re: Validation of a bioanalytic method

Posted: Fri Dec 28, 2012 1:30 pm
by JMcK
It really depends on what regulations you're trying to report to. If this is for a drug application it depends on the developmental phase of the project.

Re: Validation of a bioanalytic method

Posted: Fri Dec 28, 2012 4:23 pm
by montana
Hi,

It is for Validation of method performance for routine biochemistry analyte " creatinine in plasma and urine".

Re: Validation of a bioanalytic method

Posted: Fri Jan 04, 2013 7:14 pm
by JGK
http://www.fda.gov/downloads/Drugs/.../ ... 070107.pdf

Is a good place to start

Re: Validation of a bioanalytic method

Posted: Sat Jan 05, 2013 5:12 pm
by montana
Thank you :D
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