description of bioanalytical method validation parameters

[shantaram]

can you please help me to understand clearly the bioanalytical method validation parameters special reference to recovery, stability and specificity/selectivity. i am finding bit difficulty in understanding from FDA guidelines..

[JGK]

I take it you are using the Guidance for industry document http://www.fda.gov/CDER/GUIDANCE/4252fnl.pdf


What is it you are unsure about?

The wording of the definitions in this document are quite plain and simple (for a regulatory document) and should not be confusing.

Can you elaborate?

[anachem]

plz elaborate what wht u r nt understanding.

do some google search for the definitions u r not understanding.


M.Sc (Analytical Chemistry)

[anachem]

May be this article will help u in understanding the terms

Bioanalytical method development and validation

U K Singh, S Pandey, P Pandey, P K Keshri, P Wal


http://www.expresspharmaonline.com/2008 ... ch02.shtml


M.Sc (Analytical Chemistry)

[shantaram]

I take it you are using the Guidance for industry document http://www.fda.gov/CDER/GUIDANCE/4252fnl.pdf


What is it you are unsure about?

The wording of the definitions in this document are quite plain and simple (for a regulatory document) and should not be confusing.

Can you elaborate?

Actually sorry that i didn't explain before but i confused in long term stability that for how much time period we have to show the LT stability???

[JGK]

I take it you are using the Guidance for industry document http://www.fda.gov/CDER/GUIDANCE/4252fnl.pdf


What is it you are unsure about?

The wording of the definitions in this document are quite plain and simple (for a regulatory document) and should not be confusing.

Can you elaborate?

Actually sorry that i didn't explain before but i confused in long term stability that for how much time period we have to show the LT stability???

There is no fixed period for this. Ideally you need to cover a period long enough for you to be able to successfully analyze and reanalyze (if necessary) all possible samples. If samples are to be held in storage pending analysis you need to set the stability to cover in excess of that storage period.

[anachem]

Long Term Stability: Performed to ensure that the analyte(s) is (are) stable in matrix under predefined storage conditions (temp and containers) between the date of first sample collection and the date of last sample analysis.

>LQC and HQC Samples - 6 replicates

>Calculate %Nominal based on freshly prepared CC



M.Sc (Analytical Chemistry)

[shantaram]

Actually sorry that i didn't explain before but i confused in long term stability that for how much time period we have to show the LT stability???[/quote]


There is no fixed period for this. Ideally you need to cover a period long enough for you to be able to successfully analyze and reanalyze (if necessary) all possible samples. If samples are to be held in storage pending analysis you need to set the stability to cover in excess of that storage period.[/quote]
Thank you