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sekhar91 ● 2006-08-09 11:11 (7259 d 06:33 ago) Posting: # 198 Views: 8,477 |
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X-ray is required during the screening and any guidlines which mentioned about the X-ray, has to be done at the time of the screening in BA/BE guidlines is it compulsary |
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Helmut ★★★   Vienna, Austria, 2006-08-09 18:08 (7258 d 23:36 ago) @ sekhar91 Posting: # 201 Views: 7,130 |
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Dear sekhar91, in my personal experience (>500 BE studies) I haven't come across a single X-ray in screening. IMHO X-ray is not mentioned in any guideline for BA/BE wordwide. As already suggested by Jaime for a nice discussion have a look at these two threads at David Bourne's PKPD-list: http://www.pharmpk.com/PK03/PK2003005.html http://www.pharmpk.com/PK03/PK2003006.html — 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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vijay.bhaskar ● 2006-10-06 16:27 (7201 d 01:17 ago) @ Helmut Posting: # 288 Views: 6,789 |
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Dear HS, How can you say that the subject is fit to participate in the study without taking x-ray. in our personnel experiance we are not conducting the study without x-ray. can you explain this. -- Edit: Full quote removed. [HS] |
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Helmut ★★★ Vienna, Austria, 2006-10-06 17:36 (7201 d 00:08 ago) @ vijay.bhaskar Posting: # 290 Views: 7,059 |
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Dear Vijay! ❝ How can you say that the subject is fit to participate in the study without taking x-ray.in our personnel experiance we are not conducting the study without x-ray.can you explain this. OK, as stated in the original post my point of view comes from my personal (=European) perspective of 500+ BE studies. Additionally, I do not know a single European CRO performing X-rays in screening for BE studies on a routine basis. Since the tuberculosis incidence rate is that low (<10/100 000) in the EU, no ethics committee would accept X-ray as well (ethical grounds based on risk assessment). If you are talking from an Indian perspective (where TB is more common), you may opt for the Mantoux-test instead of X-ray testing. European incidence rates are below 10 in most countries (e.g., 6 in Austria, where I come from), but can be as high as 30 in Lithuania (also an EU-country), or 66 in Romania (new EU member state with January 2007). The rate for India is given with 75 (source). Maybe we should reconsider our procedures at least for some of the new European member states… For a Canadian perspective see here. For a discussion have a look at the links already given at David's list. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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vijay.bhaskar ● 2006-10-09 15:54 (7198 d 01:50 ago) @ Helmut Posting: # 295 Views: 6,692 |
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thanks for your reply. be in touch and update me latest happenings in BA/BE studies. |
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Helmut ★★★ Vienna, Austria, 2006-10-09 16:00 (7198 d 01:44 ago) @ vijay.bhaskar Posting: # 296 Views: 6,781 |
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Dear Vijay! ❝ thanks for your reply. You are welcome! ❝ be in touch and update me latest happenings in BA/BE studies. Just visit the forum regularily  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Helmut ★★★ Vienna, Austria, 2008-01-03 18:41 (6746 d 22:03 ago) @ Helmut Posting: # 1463 Views: 6,384 |
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Dear collegues! ❝ For a Canadian perspective see here. On 18 Dec 2007 Canada's HPFB issued an Update. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz