calculation of validation parameters.

[nageshiict]

Can some one tell how to calculate LOD and LOQ. Is there any softwares/websites for this calculation of validation parameters?

[Don_Hilton]

I think a quick look back through past discussions on this web site will show several disucssions on this topic. There are several methods used for LOD and LOQ and may require at little as a Student's t table and a calculator.

If you are working under a regulatory body, the method of calculation may be specified - in which case the options are more limited. So, are you working under a regulatory body?

[JGK]

http://www.ich.org/LOB/media/MEDIA417.pdf see sections 6 (LOD) and 7 (LOQ)

[lmh]

Do a search of this forum. There was another thread recently where many references were given.

You've got ICH Q2(R1), but see also LC-GC Europe Feb 2009 22:82-85, and references such as Epstein Pharmaceutical Chemistry Journal 38:212-225.