User Tag List

Results 1 to 2 of 2
  1. #1
    Validation Analyst
    Join Date
    Mar 2009
    Posts
    2
    Thanks
    0
    Thanked 0 Times in 0 Posts
    Mentioned
    0 Post(s)
    Tagged
    0 Thread(s)

    Smile LOD, LOQ as per ICH

    As per ICH guideline Q2(R1)
    6.3
    LOD =( 3.3 * Std. dev. of response) / Slope of calibration curve

    7.3

    LOQ =( 10 * Std. dev. of response) / Slope of calibration curve

    Please explain the methodology.
    Which calibration curve is to be used to get slope, is the linearity curve or any other?

    Again 6.3.3 & 7.3.3 talks about a specific calibration curve for sample in the range of DL & QL respectively. In that what is residual std. dev. of regression line or std. dev. of y-intercepts of regression lines may be used as std. dev.

    I did'nt understand it?

  2. #Ads
    AskaboutValidationskumar_2005 is offline

     

  3. #2
    Validation Expert
    Join Date
    Feb 2010
    Location
    Sidoarjo
    Posts
    125
    Thanks
    0
    Thanked 0 Times in 0 Posts
    Mentioned
    0 Post(s)
    Tagged
    0 Thread(s)

    Default

    I recommend you to read LCGC Oct 1998: determining limits of detection and quantitation, written by ira krull and michael swartz. there is an example ICH protocol in this article.

Tags for this Thread

Bookmarks

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  
Privacy | Terms © 2006 - 2014 askaboutvalidation. All Rights Reserved
Log in
Register