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Dr.Pravin ☆ Ahmedabad, 2006-11-13 07:55 (6373 d 06:23 ago) Posting: # 361 Views: 13,484 |
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Hi, Good Morning, can you provide me the information regarding the SOP required for BA BE unit by all regulations. and standard design of the SOP or SOP for SOP. Regard Dr Pravin — Dr.Pravin Ahir Co-Investigator, Accutest Research Pvt.Lab.(I), Ltd. Ahmedabad |
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Helmut ★★★   Vienna, Austria, 2006-11-13 12:27 (6373 d 01:50 ago) @ Dr.Pravin Posting: # 363 Views: 12,189 |
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Hi Dr. Pravin! ❝ can you provide me the information regarding the SOP required for BA BE unit by all regulations. A good start is Annex 9 (Additional guidance for organizations performing in vivo bioequivalence studies) of the Fortieth Report (WHO Technical Report Series No. 937)'. I don't know of any countries specific regualtions... ❝ ...and standard design of the [...] SOP for SOP. Do you mean the first SOP (the one which describes how to write SOPs)? In the German language we have a nickname for this SOP, namely 'Ursuppe', which means 'primordial soup'  This SOP should describe the managagement of all SOPs (preferably you should prepare a template for your word processor), including all necessities suitable for your organization (title page, signatures, dates for coming into operation, written by, approved by, replaces version no., changes from last version, revision and filing procedures,...) — 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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sekhar91 ● 2006-11-22 13:44 (6364 d 00:34 ago) @ Helmut Posting: # 370 Views: 12,130 |
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the FDA mentioned about the format of the SOPs and WHO provided the list of hte SOPS required for clinical studies. |
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Helmut ★★★ Vienna, Austria, 2006-11-22 14:06 (6364 d 00:11 ago) @ sekhar91 Posting: # 371 Views: 12,031 |
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Dear sekhar91! ❝ the FDA mentioned about the format of the SOPs... Can you please provide us with a reference (preferably a direct link)? ❝ ...and WHO provided the list of hte SOPS required for clinical studies. ... as already mentioned. Note: Please be polite, and avoid full quotes. Thank you (I edited your post). — 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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sekhar91 ● 2006-12-22 12:04 (6334 d 02:14 ago) @ Dr.Pravin Posting: # 415 Views: 11,782 |
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dear Dr.Pravin, WHO mentioned some SOPs list which required by CROs to conduct the studies. I think it may useful to u to get some idea. http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS05_120Rev1_CROs.pdf |
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Helmut ★★★ Vienna, Austria, 2006-12-22 13:30 (6334 d 00:48 ago) @ sekhar91 Posting: # 416 Views: 11,885 |
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Dear sekhar, you are referring to a drafted document: ❝ http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS05_120Rev1_CROs.pdf As already stated, the actual reference is Annex 9 (Additional guidance for organizations performing in vivo bioequivalence studies) of the Fortieth Report (WHO Technical Report Series No. 937)' (PDF pages 451-473, printed report pages 439-461). In your previous post you mentioned FDA's 'format of the SOPs'. Do you have a link handy? — 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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Sumanta Goswami ☆ India, 2007-01-16 18:25 (6308 d 19:53 ago) (edited by HS on 2007-02-16 10:44) @ Helmut Posting: # 472 Views: 11,724 |
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Dear group members, can you please refer me any link stating SOPs required for conducting clinical trials? During previous discussion we could know about SOPs required for conducting ba/be study. What additional SOPs we need for Clinical Trial? Regards, Sumanta. -- Edit: Full quote removed. [Helmut] |
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venu ☆ Mumbai, India, 2007-02-16 09:04 (6278 d 05:13 ago) (edited by HS on 2007-02-16 10:44) @ Sumanta Goswami Posting: # 526 Views: 11,666 |
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Dear HS, Please if you could give some links related to List of SOPs in Clinical Trials.  Thank You -- Edit: Full quote removed. [Helmut] — Best Regards, Ms. Vandana Panchal Biostatistician Mumbai India |
Ing. Helmut Schütz