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esreddy ☆ 2009-04-15 08:35 (6276 d 18:31 ago) (edited on 2009-04-15 10:13) Posting: # 3528 Views: 4,014 |
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When conducting Bioequivalance study, after completion of Period-I, if any changes in the Bioanalytical facility, how can we proceed? Can I send the samples to changed facility with just mail communication without amendment to the protocol. Please anybody give me clarification. -- Edit: Category and subject line changed. Please see the Policy here. Since nobody is willing to read, writing obviously is a hard business too. Slowly I'm getting fed up. [Jaime] |
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pmgjoshi ☆ India, 2009-04-15 09:50 (6276 d 17:15 ago) (edited on 2009-04-15 10:22) @ esreddy Posting: # 3529 Views: 3,300 |
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Dear esreddy, If you are moving the whole Bioanalytical facility (equipments too) then after installation you will have to calibrate the machines and confirm if it meets the vendor's specifications (for e.g. for LC-MS/MS we inject PPG and check whether we meet the acceptance criteria). Then, please refer the 'Guidance for Industry, Bioanalytical Method Validation--B'. 'Partial Validation- first point i.e. Bioanalytical method transfers between laboratories or analysts'. You can analyze a single Precision and Accuracy batch. And it will be the amendment to 'Method Validation Protocol and Report' (an addendum for 'Ruggedness'). And if it's good I think there shouldn't be any problem regulatory point of view.  -- Edit: Full quote removed. Please see this post - and that one also! Since nobody is willing to read, writing obviously is a hard business too. Slowly I'm getting fed up. [Jaime] |
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esreddy ☆ 2009-04-15 21:13 (6276 d 05:53 ago) (edited on 2009-04-15 22:52) @ pmgjoshi Posting: # 3540 Views: 3,131 |
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Total facility is not moving. Sponsor wants to conduct Analysis facility not mentioned in protocol. -- Edit: full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Ohlbe ★★★ France, 2009-04-16 00:56 (6276 d 02:09 ago) @ esreddy Posting: # 3541 Views: 3,147 |
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Dear esreddy, When answering messages, please delete anything from the text of the original message which is not necessary in understanding your answer; see also this post and the forum policy. You even kept Jaime's edit, asking pmgjoshi to avoid full quotes ! Regards Ohlbe |
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krish3108 ☆ 2009-05-04 12:10 (6257 d 14:56 ago) @ esreddy Posting: # 3645 Views: 2,979 |
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Dear Esreddy, As per the guidelines the protocol should mention the analytical facility, if the sponsor latter wants to change the facility, then it would lead to protocol amendment and the same to be approved by the Ethics commitee. Have a change control document perapred mentioning the reason for the facility change. Regards Krish --- Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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