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shiv ● 2006-01-25 07:39 (6660 d 05:45 ago) Posting: # 60 Views: 16,038 |
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BE studies for Brazil is after ANVISA approval |
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H_Rotter ★ Germany, 2006-01-25 13:31 (6659 d 23:52 ago) @ shiv Posting: # 62 Views: 12,258 |
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Dear shiv, ...and what is your question?  |
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shiv ● 2006-01-27 09:14 (6658 d 04:09 ago) @ H_Rotter Posting: # 66 Views: 12,360 |
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Dear Rotter, Conducting BE studies for brazil market is only after anvisa inspection and approval or after the study, submission of documents and inspection process (Like FDA)? |
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H_Rotter ★ Germany, 2006-01-27 15:00 (6657 d 22:23 ago) @ shiv Posting: # 68 Views: 12,197 |
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Dear shiv, it's different from the FDA. The center(s) performing the study must follow ANVISA's rules (http://www.anvisa.gov.br/eng/legis/resol/103_03rdc_e.htm), must be inspected (http://www.anvisa.gov.br/eng/bio/form_bio.doc), and renew their status anually (http://www.anvisa.gov.br/eng/bio/form_renewal.rtf). After approval of the protocol by the local IEC, the study may be performed. Only if your protocol deviates from ANVISA's standards (e.g. if you want to perform at multiple dose study in order to reduce variability for HVDs), I would strongly recommend contacting them before. good luck! Hermann Rotter |
Ing. Helmut Schütz