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stdev ☆ Greece, 2012-01-11 20:01 (5268 d 22:06 ago) Posting: # 7903 Views: 5,921 |
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Dear all, I would like to validate my excel software for a bioequivalence study but I am not sure what procedure would be the best to follow. If anyone could give me some advice this would be of great help! Thank you in advance! Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2012-01-12 05:25 (5268 d 12:41 ago) @ stdev Posting: # 7906 Views: 5,069 |
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Καλημέρα Μάκη! See what Martin said first.  I don’t think that EMA would accept Excel for BE. See the ‘Questions & Answers: Positions on specific questions addressed to the Pharmacokinetics Working Party’ (Rev. 3, 2011), Section 3.3 Alternative computer programs SAS (version 9.1, SAS Institute Inc, NC) was used in the previous computations. Results obtained by alternative, validated statistical programs are also acceptable except spreadsheets because outputs of spreadsheets are not suitable for secondary assessment. (my emphasis)— 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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MGR ★ India, 2012-01-12 06:28 (5268 d 11:39 ago) @ stdev Posting: # 7909 Views: 4,901 |
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Dear stdev, The following links may be helpful for your question: An article: Using of Excel Sheets An External Source (Lab Compliance): Excel and Macros Validation An PPT: Excel Spreadsheets and FDA Device Regulations Besides these, You have to follow your own internal procedures / protocols / SOP's/ Calculations, etc Thank you, — Regards, MGR |
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stdev ☆ Greece, 2012-01-13 01:23 (5267 d 16:44 ago) @ MGR Posting: # 7919 Views: 4,908 |
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Thanks to everyone! Your posts were very helpful! |
Ing. Helmut Schütz