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sambasivarao ☆ 2010-10-06 08:10 (5744 d 08:45 ago) Posting: # 6004 Views: 4,862 |
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Is the batch repeat comes under repeat analysis percentage calculations? If yes please justify. There are some regulatories suggesting not to do more than 20% of samples under repeat analysis. (The said 20% is only individual repeats or including batch repeats?) |
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Jaime_R ★★ Barcelona, 2010-10-12 16:15 (5738 d 00:40 ago) @ sambasivarao Posting: # 6041 Views: 3,907 |
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Hi Sambasiva! First see here, please. ❝ Is the batch repeat comes under repeat analysis percentage calculations? If yes please justify. Yes - if an entire batch fails, you are using only the values of the repeated batch for PK, right? Therefore Nº of repeated samples = size of batch. ❝ There are some regulatories suggesting not to do more than 20% of samples under repeat analysis. (The said 20% is only individual repeats or including batch repeats?) 20% of the study's samples, irrespective of the reason (batch repeat or individual repeats like sample processing error, equipment failure, dilution of samples >ULOQ, etc.). Just my 2¢. — Regards, Jaime |
Ing. Helmut Schütz