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Geokad ☆ Canada, 2008-09-30 23:15 (6475 d 11:39 ago) Posting: # 2454 Views: 3,966 |
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Hello, As per the FDA guidance for method validation, A calibration curve should consist, among other things, of six to eight non-zero samples covering the expected range, including LLOQ. Furthermore, in the acceptance criteria for the run, they require 75%, or a minimum of six standards meeting acceptance criteria. (75% represents 6 out of 8 calibrants). My question is: if there are 10 standards in the calibration curve, does the minimum of 6 apply or the 75% which is 8 out of 10 does? I think that they specified a minimum of 6 because it's 75% of the example they gave which is 8 standards. Regards. Geokad Great job you are doing here.  -- Edit: Category changed. [Ohlbe] |
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Ohlbe ★★★ France, 2008-10-01 00:02 (6475 d 10:52 ago) @ Geokad Posting: # 2455 Views: 3,119 |
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Dear Geokad, My interpretation would be 75 % or 6, whichever is greater (or 75 %, with a minimum of 6). If you have 6 to 8 calibration samples in your curve: at least 6 should pass. If you have 12 calibration samples: at least 9 should pass. The problem comes with how to interpret the guidance when 75 % gives you decimals: 75 % of 10 is 7.5, should you go for at least 7, or at least 8 ? I guess the FDA would say at least 8... ❝ Great job you are doing here. Thanks ! Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2008-10-01 12:35 (6474 d 22:19 ago) @ Ohlbe Posting: # 2458 Views: 3,153 |
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Dear Ohlbe & Geokad, ❝ The problem comes with how to interpret the guidance when 75 % gives you ❝ decimals: 75 % of 10 is 7.5, should you go for at least 7, or at least 8 ? ❝ I guess the FDA would say at least 8... Agree; just my 2 cents! — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Geokad ☆ Canada, 2008-10-01 17:24 (6474 d 17:31 ago) @ Helmut Posting: # 2462 Views: 3,149 |
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Hi Ohlbe & HS, Thank you both for your prompt reply. I fully agree. Regards. Geokad |
Ing. Helmut Schütz