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vish14184 ★ India, 2007-10-12 08:18 (6836 d 14:58 ago) Posting: # 1176 Views: 5,008 |
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Dear All Is there any guidelines/articals for preparation of protocol for bioequivalence study? Regards Vishal Nakrani |
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Helmut ★★★   Vienna, Austria, 2007-10-12 15:45 (6836 d 07:32 ago) @ vish14184 Posting: # 1181 Views: 4,036 |
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Dear Vishal! ❝ Is there any guidelines/articals for preparation of protocol for ❝ bioequivalence study? Please see this post first. Hints: WHO, FDA (USA), ANVISA (Brazil), FDA (Thailand),... — 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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Rajdeep ★ New Delhi, India, 2007-10-13 10:10 (6835 d 13:06 ago) (edited on 2007-10-13 13:35) @ Helmut Posting: # 1185 Views: 3,923 |
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❝ Please see this post first. ❝ Hints: WHO, FDA (USA), ANVISA (Brazil), FDA (Thailand),... Dear Sir I am into protocol writing too. Can you please mention the appropriate guidance document for US/FDA and EU submission. regards Rajdeep -- Edit: Full quote removed. Please see this post! [Jaime] — Best regards Rajdeep Mukherjee Protocol Developer |
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Ohlbe ★★★ France, 2007-10-13 17:00 (6835 d 06:16 ago) @ Rajdeep Posting: # 1187 Views: 4,096 |
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Dear Vishal and Rajdeep, No specific guideline for BE protocols. General provisions in the ICH E6 guideline. Also have a look at general principles in the E8 guideline. This will be valid for USA, EU, Japan, and countries following ICH guidelines such as Canada and Australia. See also Appendix 2 of WHO's GCP guideline. For other countries search the guidance page, I don't know them all by heart ! For general information on BE trials design have a look at the BE guideline of the country in which you intend to submit the data. They are all listed in the guidance page, I won't list them again here. Do your own homework too... Regards Ohlbe |
Ing. Helmut Schütz