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chidambarajoshi ★ Hyderabad-INDIA, 2008-01-09 12:02 (6748 d 12:55 ago) Posting: # 1481 Views: 3,236 |
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Dear all, In US FDA Bionalytical method validation guideline "For selectivity, analyses of blank samples of the appropriate biological matrix (plasma, urine, or other matrix) should be obtained from at least six sources. Each blank sample should be tested for interference, and selectivity should be ensured at the lower limit of quantification (LLOQ)" what exactly it mean? Should six lots extracted blank to be compared with six lots of extracted spiked LLOQ or Should six lots extracted blank to be compared with one lot of extracted spiked LLOQ ? Regards Joshi  — Best Regards Joshi |
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chiragkhatri ★ India, 2008-01-10 10:18 (6747 d 14:39 ago) @ chidambarajoshi Posting: # 1492 Views: 2,521 |
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Dear Joshi, Normal practice what we follow to satisfy the said criteria is extract from each lot of matrix a blank and LOQ and check for interference and selectivity. Regards Chirag |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-01-11 05:57 (6746 d 19:00 ago) @ chiragkhatri Posting: # 1504 Views: 2,454 |
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Dear Chirag, Thanks for the reply. But I had observed people do the blank exction of all the batches and they do compare with only one spiked extracted LLOQ. Is it acceptable?  Regards, Joshi — Best Regards Joshi |
Ing. Helmut Schütz