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Pandu ★ India, 2008-02-18 12:01 (6294 d 10:11 ago) (edited on 2008-02-19 22:01) Posting: # 1616 Views: 8,201 |
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Hai to all, What is an outlier? How to identify it? Is there is any methods for identifying the outliers and explain it? We are doing the pivotal study. In that one subject was showing different from all. Now we can consider as that subject as an outlier. Include that subject study was fail and exclude that subject study was pass. Now how to we present the data to regulatory. Is regulatory accepts the such these type of outliers? Please explain the about these as early as possible. Regards, Pandu -- Edit: Category changed. [Ohlbe] |
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Nirali ★ India, 2008-02-19 06:49 (6293 d 15:23 ago) @ Pandu Posting: # 1620 Views: 6,748 |
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Dear Pandu, USFDA, ANVISA & EMEA has clearly defined about outliers in their guidelines. ANVISA (BRAZIL) has defined outlier method in thier statistical volume-III. As per my knowledge, no regulatory accept outlier solely basis of statistics. You required to give sound clinical justification. Also, required to submitt BE limits with and without outlier. May I know your submission is for which regulatory? Thanks & Regards, Nirali |
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Ohlbe ★★★ France, 2008-02-19 23:00 (6292 d 23:12 ago) @ Pandu Posting: # 1622 Views: 6,577 |
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ShankarCL ● 2008-02-29 06:51 (6283 d 15:21 ago) @ Pandu Posting: # 1641 Views: 6,451 |
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Dear Pandu, Most regulatories are very critical of the outliers. For EU, the opinion differes with different country acting as the RMS. For USFDA you have a reasonable chance with justification. Shankar |
Ing. Helmut Schütz