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description of bioanalytical method validation parameters
Posted: Mon Apr 06, 2009 8:58 am
by 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..
Posted: Fri Apr 17, 2009 12:16 am
by 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?
Posted: Fri Apr 17, 2009 1:24 am
by anachem
plz elaborate what wht u r nt understanding.
do some google search for the definitions u r not understanding.
M.Sc (Analytical Chemistry)
Posted: Fri Apr 17, 2009 3:44 am
by 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)
Posted: Fri Apr 17, 2009 10:24 am
by 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???
Posted: Sat Apr 18, 2009 12:09 am
by 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.
Posted: Sat Apr 18, 2009 12:18 am
by 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)
Posted: Sat Apr 18, 2009 6:11 am
by 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