Validation of a bioanalytic method

[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

[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.

[montana]

Hi,

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

[JGK]

http://www.fda.gov/downloads/Drugs/.../ ... 070107.pdf

Is a good place to start

[montana]

Thank you