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gunta ☆ 2009-08-25 22:22 (6147 d 22:27 ago) Posting: # 4112 Views: 4,025 |
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Dear group members, we are doing subject sample analysis based on validation range. And we have completed one study dosage (500mg). But dosage for next study became half (250mg). We reduced Calibration Curve STD1 to half of original. But changed Calibration Curve range within the Validation range. Shall I continue my study analysis or is there any need to perform partial validation? Thanks in advance Regards, gunta |
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Helmut ★★★   Vienna, Austria, 2009-08-25 22:31 (6147 d 22:18 ago) @ gunta Posting: # 4113 Views: 3,293 |
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Dear Gunta! If your new lowest CC-standard is within the validated range of the method IMHO there is no need for a revalidation. I assume that you have also data at the new LLOQ? — 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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gunta ☆ 2009-08-27 07:44 (6146 d 13:05 ago) @ Helmut Posting: # 4123 Views: 3,278 |
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Dear HS, Thank you for your reply. LLOQ has not changed for new calibration curve range. But change has been at ULOQ. first range is 20ng to 8000ng (validation range). New range is 20ng to 4000ng without change in LLOQ. Hoping to get your reply, Thanks and Regards, gunta. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2009-08-27 18:01 (6146 d 02:49 ago) @ gunta Posting: # 4126 Views: 3,389 |
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Dear Gunta! ❝ […] first range is 20ng to 8000ng (validation range). New range is 20ng to 4000ng without change in LLOQ. Nothing in FDA’s guidance, but in the Arlington III Whitepaper: Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, and R Weiner Workshop/Conference Report – Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays The AAPS Journal 9(1), E30-E41 (2007) online resource If a narrow range of analysis values is known or anticipated before the start of sample analysis, it is recommended that either the standard curve be narrowed and new QC concentrations used as appropriate, or if the original curve is used, existing QC concentrations be revised or sufficient QC samples at additional concentration(s) added to adequately reflect the concentrations of the study samples. Narrowing of the standard curve and preparation of new QC samples requires only a partial validation to ensure adequate performance of the new curve and QCs. A full validation is not required. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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gunta ☆ 2009-08-30 20:44 (6143 d 00:05 ago) @ Helmut Posting: # 4135 Views: 3,162 |
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Ing. Helmut Schütz