krishna tiwari ☆ India, 2016-04-26 13:24 (2893 d 10:13 ago) (edited by Ohlbe on 2016-04-26 14:14) Posting: # 16240 Views: 2,705 |
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Dear All, we are going to conduct BA/BE study in ANVISA regulatory requirements. in indian population. please let me know .... we are conduct the study or not. or study will be conducted only brazilian population only?? which anvisa guideline resolution clearly says pls let me know. thanks krishna Edit: category changed [Ohlbe] |
felipeberlinski ☆ Brazil, 2016-04-27 17:07 (2892 d 06:30 ago) @ krishna tiwari Posting: # 16249 Views: 2,154 |
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Hi Krishna There is no such need. You can conduct in Indian population. Take a look on RE 1170/06 there you'll find valuable information about ANVISA requirements, it is important to read the guidelines. |