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Phaneendra.K ☆ 2010-12-31 15:51 (5246 d 08:48 ago) Posting: # 6364 Views: 6,163 |
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How do the drugs effect the changes in Laboratory parameter values like total RBC count, Haemoglobin, total Bilirubin. If a post-study change in a laboratory parameter value is noticed, can it be attributed to the IP only. — Thanks and Regards, PK |
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Helmut ★★★   Vienna, Austria, 2010-12-31 17:35 (5246 d 07:04 ago) @ Phaneendra.K Posting: # 6373 Views: 5,162 |
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Dear Phani! ❝ How do the drugs effect the changes in Laboratory parameter values like total RBC count, Haemoglobin, total Bilirubin. If a post-study change in a laboratory parameter value is noticed, can it be attributed to the IP only. Changes in these parameters are common – not due to the drug(s), but caused by blood loss during the study. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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suchit_bhavsar ★ India, 2011-01-29 08:03 (5217 d 16:36 ago) (edited on 2011-01-29 14:41) @ Helmut Posting: # 6513 Views: 4,875 |
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brijeshmaroj ☆ 2011-02-21 10:51 (5194 d 13:48 ago) @ suchit_bhavsar Posting: # 6653 Views: 4,712 |
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Dear Suchit, It will be at the discretion of Investigator, who will assess the degree of deviation from the reference range values Causality assessment (Definite, Probable, Possible, Remote/ Unlikely, Not Related) will be done basing on
Hope this will help. Best regards, Dr. Brijesh |
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Dr_Dan ★★ Germany, 2011-02-21 16:52 (5194 d 07:47 ago) @ brijeshmaroj Posting: # 6654 Views: 4,702 |
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Dear Suchit, dear Dr. Brijesh just to specify: although laboratory parameters vary as Helmut explained any deviation of laboratory parameters from within (at screening) to out of the reference range (for example at final examination) should be regarded as AE. It is at the discretion of the investigator to judge this deviation as "clinically significant" or "clinicall not significant". I agree with the causality assessment as proposed by Dr. Brijesh. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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suchit_bhavsar ★ India, 2011-03-02 13:39 (5185 d 11:00 ago) @ Dr_Dan Posting: # 6684 Views: 4,724 |
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Then it will be recorded as a period 2 post study AE or after completion of study AE?? And one more thing How we will record in DBE tables? 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] Edit: Please follow the forum Forum’s Policy. If you want to write an SMS, you are using the wrong device.  [Helmut] |
Ing. Helmut Schütz