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Rahul007 ● 2007-03-03 07:50 (6648 d 00:46 ago) Posting: # 555 Views: 5,007 |
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Dear all, I am new user. I am working as formulation developer working on locally acting solid formulation (Tablet and Capsule). I am confused about to conduct BE study and what will be the protocol. Is there is any chance to get waiver or we have to established clinical equivalence. Regards, Rahul |
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drshiv ★ India, 2007-03-04 19:48 (6646 d 12:47 ago) (edited on 2007-03-06 11:25) @ Rahul007 Posting: # 556 Views: 4,271 |
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Hi Rahul, It is wise to elaborate on locally acting solid formulation at this point for any one to provide you guidance. If you mention tablet and capsule generally it is assumed oral formulation. If it so, it may be some formulation locally acting in GIT. Further assumption would be, the drug in the formulation may not be available systemically and hence to provide BE data on such formulation would be difficult, therefore you may have to do clinical study to prove the point. Refer waiver points given in ICH or USFDA guidance on BA/BE studies. If your formulation does not fall under these points you may have to do the BE study. Also do not forget to ask guidance with more clarification on the type of drug and formulation you are working on. Someone may really give you some direction. Dr. Shiv Edit: Full quote removed. [Helmut] |
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bhushanjoshi ● 2007-03-14 13:14 (6636 d 19:22 ago) @ Rahul007 Posting: # 578 Views: 4,100 |
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❝ I am new user. I am working as formulation developer working on locally acting solid formulation (Tablet and Capsule). If you are working on ASACOL and PENTASA then do let us know ?  ❝ I am confused about to conduct BE study and what will be the protocol. Is there is any chance to get waiver or we have to established clinical equivalence. |
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Rahul007 ● 2007-03-15 11:11 (6635 d 21:25 ago) @ bhushanjoshi Posting: # 580 Views: 4,097 |
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❝ If you are working on ASACOL and PENTASA then do let us know ? Yes boss i am working on both.  |
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bhushanjoshi ● 2007-03-15 14:15 (6635 d 18:20 ago) (edited on 2007-03-15 20:05) @ Rahul007 Posting: # 581 Views: 4,063 |
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If you are working for Regulated market like US & Eu then please contact Regulatory authorities as guideline for both products are different and clinical study is required. Protocol needs to be approved first. Secondly for development purpose BE could be done. Thinking that you want zero release in first phase of drug transition through GIT. Hope this helps you.  Edit: Full quote removed. [Helmut] |
Ing. Helmut Schütz