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swayog81 ● 2009-02-27 07:53 (6326 d 14:44 ago) Posting: # 3293 Views: 7,169 |
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I have to select number of incurred sample for reanalysis, my question is: How many samples to be consider for reanalysis? |
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nvs ☆ India, 2009-02-27 10:31 (6326 d 12:05 ago) @ swayog81 Posting: # 3294 Views: 6,244 |
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Dear swayog, At least 5% of total study samples from 33% of randomly selected subjects can be taken for ISR. 67% of samples should be + 20% (% difference) is the specification for the ISR.  |
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swayog81 ● 2009-02-27 14:04 (6326 d 08:33 ago) (edited on 2009-02-27 18:03) @ nvs Posting: # 3295 Views: 6,163 |
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Ohlbe ★★★ France, 2009-02-27 19:05 (6326 d 03:32 ago) @ nvs Posting: # 3297 Views: 6,176 |
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Dear nvs, Any reference for these recommendations ? I've seen the 67 % / 20 % figures before, but the 33 % of subjects is new to me. Regards Ohlbe |
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nvs ☆ India, 2009-03-02 09:09 (6323 d 13:28 ago) @ Ohlbe Posting: # 3304 Views: 6,094 |
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Dear Ohlbe, These recommendations we took from AAPS journals, and 33% is our in house practice we are proving ISR by taking maximum no. of randomized subjects (33%). Regards' nvs. |
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chiragkhatri ★ India, 2009-03-05 11:07 (6320 d 11:29 ago) @ nvs Posting: # 3318 Views: 6,123 |
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Dear all, Is it a compulsion to do the incurred sample reanalysis? which guidelines advises this Regards Chirag -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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Ohlbe ★★★ France, 2009-03-05 11:16 (6320 d 11:21 ago) @ chiragkhatri Posting: # 3319 Views: 6,202 |
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Dear Chirag, No guideline so far. But the FDA announced that they would now require it at the Crystal City meeting in May 2006. So far it is only required for US submissions, as far as I know. Regards Ohlbe |
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gopi2577 ☆ 2010-02-05 18:31 (5983 d 04:05 ago) @ swayog81 Posting: # 4717 Views: 5,632 |
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Dear All, Thanks in advance, please guide me to select the no. of samples to be analysed for ISR, total no. of study samples is 1008 for 24 subjects. Regards Gopi |
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babu ☆ India, 2010-03-23 12:03 (5937 d 10:33 ago) @ gopi2577 Posting: # 4958 Views: 5,529 |
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As per AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples: The number of samples repeated should equal 5–10% of the total sample size, with 5% as the minimum for larger studies. Thanks, babu. |
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gopi2577 ☆ 2010-03-23 20:14 (5937 d 02:22 ago) @ babu Posting: # 4963 Views: 5,470 |
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Dear Babu, thanks for your reply, 5% as the minimum for larger studies means how we can identify larger study. Now we have selected 10% of the samples for first 1000 no. of samples and samples from 1001 and above as 5%, a total of 10% + 5% of samples have analysed for ISR, for eg. 1008 study sample 100+1(10% + 5%)=101 samples is analysed is correct please guide me, thanks in advance. thanks Gopi Edit: Full quote removed. Please see this post! [Helmut] |
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vajra123 ☆ India, 2010-04-14 07:48 (5915 d 15:48 ago) @ swayog81 Posting: # 5111 Views: 6,477 |
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Dear Swayog81, Recently European Medical agency has drafted there Bioanalytical Method Validation guidelines. i hope ur also aware of that. In the Draft guidelines the specifications for the acceptance of ISR has been provided. Regarding to your query regarding the selection of the number of subject samples it depends on the Inhouse SOP's. The selection of samples should be in such a way that it should cover the maximum number of samples. I hope this is useful. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/12/WC500018062.pdf Regards, Vajra123 — Vajra |
Ing. Helmut Schütz