By Anonymous on Tuesday, February 3, 2004 - 07:30 pm:
I was hoping that someone would be able to help me with how to determine ruggedness. does anybody have any suggestions or a link to guide me.
thank you in advance
By B.Buglio on Wednesday, February 4, 2004 - 06:53 am:
Ruggedness is an indication of the reproducibility
of a method and relates esp to method transfer.
The conditions typically tested are the degree of
reproducibility with different:
* laboratories
* analysts
* instruments
* days
* reagents
By Anonymous on Wednesday, February 4, 2004 - 09:49 am:
Thank you for your help.
How would one go about reporting these. is it in rsd. also with regards to reagents, would it be different stocks, different reagent vendor, slightly varying the concentrations. Im new to this parameter and would appreciate any help.
Thank you
By B.Buglio on Wednesday, February 4, 2004 - 05:16 pm:
Evaluation is typically expressed as RSD or%RSD.
At this point some background information should
be useful. Method validation is discussed in the
ICH site:www.ICH.org. Follow the links
Publications>Guidelines>Quality Topics>Q2A&A2B. Be
aware that ICH "intermediate precision" and FDA
"ruggedness" are the same. The FDA has a CDER
Guideline site that presents essentially the same
validation material.