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docksr ☆ India, 2013-06-21 13:32 (4752 d 06:24 ago) Posting: # 10848 Views: 3,099 |
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Do we require a new DCGI application or can we just intimate to DCGI for the change with another RLD; for a already previously approved protocol with the other RLD? |
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drgunasakaran1 ★★  2013-06-22 08:02 (4751 d 11:54 ago) @ docksr Posting: # 10862 Views: 2,541 |
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❝ Do we require a new DCGI application or can we just intimate to DCGI for the change with another RLD; for a already previously approved protocol with the other RLD? Dear Docksr, Kindly follow Forum Policy You need to go for new DCGI BENOC application if the RLD is being changed. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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docksr ☆ India, 2013-06-22 10:29 (4751 d 09:27 ago) @ drgunasakaran1 Posting: # 10863 Views: 2,537 |
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❝ You need to go for new DCGI BENOC application if the RLD is being changed. Thank you Dr Gunasakaran for the clarification. I was wondering when both the RLDs are approved by FDA, why DCGI should insist for new BENOC ? Notification should suffice for a change of RLD ! Regards, Dr.Sudakar Reddy Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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drgunasakaran1 ★★ 2013-06-24 08:27 (4749 d 11:29 ago) @ docksr Posting: # 10867 Views: 2,434 |
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Dear Dr Sudakar Reddy, DCGI insists for new BENOC application since the Certificate of Analysis of new RLD to be used in the BE study and the dissolution profile differs for the new RLD vs test formulation. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz