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Bhavesh ☆ India, 2009-08-14 07:04 (5750 d 01:04 ago) Posting: # 4045 Views: 6,843 |
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hi , I required some clarification (BA-BE studies) In two Period study with ambulatory collection , I had performed lab investigation in check in and at check out of P-II. Also I have critera in protocol for lab investigation at last ambulatory. I didn't get any value of lab paramenter that is significant at the time of check out lab investigation of P-II but got value significant at ambulatory lab investigation. In this case I consider it its due to drug administered. I confused bcoz it is not obtained at check out lab investigation and at that time drug concentration in body is higher than at time of ambulatory. |
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kiranActimus ☆ India, 2009-08-14 12:14 (5749 d 19:54 ago) @ Bhavesh Posting: # 4048 Views: 5,587 |
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Dear Bhavesh According to ICH GCP Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. May be as u said the abnormality in the lab investigations is not because of the drug concentration we shall treat it as an adverse event only. There are so many reasons for the change in the lab investigations other than the drug effect. It may be due to changes in the dietary habits etc., From the available literature of the past studies we can predict the possible side effects. If the abnormalities in the lab investigations are observed in the past studies we can say it is due to drug otherwise we need to investigate the cause of the abnormalities. Thanks®ards KK |
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Bhavesh ☆ India, 2009-08-17 09:41 (5746 d 22:27 ago) @ kiranActimus Posting: # 4050 Views: 5,569 |
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Dear KK, I agree with you but confusion arise during report preparation. Under which treatment I shall consider it. because we specify AE in percentage respective of treatment and based on that final conclusion will drawn. Bhavesh Shah 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! [Helmut] |
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kiranActimus ☆ India, 2009-08-17 11:02 (5746 d 21:06 ago) @ Bhavesh Posting: # 4051 Views: 5,640 |
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Dear Bhavesh Consider the Adverse event under the treatment given for the subject in Period -II and mention the Adverse event as unrelated to the drug in the report Thanks& Regards KK |
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taresh41 ☆ Mumbai, 2009-08-17 15:13 (5746 d 16:56 ago) @ Bhavesh Posting: # 4054 Views: 5,628 |
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Dear Bhavesh I totally agree with KK, i would like to add to it, that you can report the Adverse events in two formats in final report i.e. 1) Adverse Events occurred during study (here you can mention the treatment). 2) Post study Adverse events (i.e Abnormal post study finding at the completion of the last period or last ambulatory of the last period.) Hope this helps you Bhavesh. — Thanks & Regards, Taresh |
Ing. Helmut Schütz