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sambasivarao ☆ 2010-10-06 12:40 (5745 d 06:30 ago) Posting: # 6006 Views: 4,128 |
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If I am able to Extract 30% of drug from plasma for specific molecule and it is reproducible & Same throught my Calibration curve range. Now how to justify a auditor as i got less recovery? |
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Helmut ★★★   Vienna, Austria, 2010-10-06 14:53 (5745 d 04:17 ago) @ sambasivarao Posting: # 6008 Views: 3,384 |
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Dear Sambasiva, first look here. If the method is validated according to the original definition (“… demonstrated to be reliable and reproducible for the intended use”) any (!) recovery should be acceptable. If your method is sensitive enough even with a low recovery, fine. According to the FDA’s 2001 guidance (and countries following closely, like ANVISA) you have to report your findings – there’s no lower limit for acceptability: Recovery of the analyte need not be 100%, but the extent of recovery of an analyte and of the internal standard should be consistent, precise, and reproducible. (my emphasis)The EMA in their 2009 draft GL went one step further; recovery is not mentioned at all.  ❝ Now how to justify a auditor as i got less recovery? Patient and politely. Celebrating login #3000 today. — 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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