validation: accuracy

[vicentexxx]

hi,
simple question for you...

I'm validating an analytical method and i'm studying accuracy.
i usually worked in a range 90-110 or 80-120 so that i had 15 data (5 data per level with 90-100-110 or 3 per level with 80-90-100-110-120).
Now i'm investigating this procedure that i learnt by my precursors but i can't find any specific information about samples number to have during accuracy studies (i refer to ICH and EMEA)...
can someone light me about this matter?


thank you in advance
Vincenzo

[gbalock]

Vincenzo,
ICH Guideline Q2(R1) Part II Section 4 says use a three by three over the range of your assay range (in US 90-110, so I would do at least 85-115)

[vicentexxx]

thank you gbalok,

i found it in "recomended data"

[Alex Buske]

ICH 2A point 4 Accuracy says "Across the specified range of the analytical procedure"
They are not talking about specifications of you DS/DP. I assume with "range" the method range (point 3 of that guideline) is meant: 80-120% for assay, 70-130 for uniformity tests
alex

[vicentexxx]

yes you have to performe accuracy test in your range, but 80-120 70-130 are only advices...
if you want you can enlarge it or increase levels...