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swapnil.kuche ★ 2011-07-19 13:19 (5458 d 20:50 ago) Posting: # 7216 Views: 3,592 |
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Dear All, I want some reference document which will describe different clinical trial requirements for NDDS (Novel Drug Delivery system) Can you please provide me such a reference document which will explain clinical trials needs to be conducted if novel delivery system is formulated for existing generic product? Looking forward for your response. Best Regards, Swapnil D. Kuche |
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ElMaestro ★★★ Denmark, 2011-07-19 13:50 (5458 d 20:19 ago) @ swapnil.kuche Posting: # 7218 Views: 3,058 |
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Hello Swapnil, ❝ I want some reference document which will describe different clinical trial requirements for NDDS (Novel Drug Delivery system) could you please tell a lot more about the product: Are you aiming to get a approval for a delivery system with or without drug integrated? Where (EU, US, India, ...?)? What is the nature of this system? Is the delivery local or systemic? — Pass or fail! ElMaestro |
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swapnil.kuche ★ 2011-07-19 14:06 (5458 d 20:03 ago) @ ElMaestro Posting: # 7219 Views: 3,038 |
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Dear Elmaestro, First of all thanx for your prompt response. ❝ could you please tell a lot more about the product: One product is modified release oral solid and another one is transdermal patch. ❝ Are you aiming toget a approval for a delivery system with or without drug integrated? We are targeting to get approval only for delivery system. Drug is already available as generic. ❝ Where (EU, US, India, ...?)? It will be very appreciable if you elaborate requirements for all markets mentioned above. ❝ What is the nature of this system? 1) Extended release tablets 2) Transdermal patches. ❝ Is the delivery local or systemic? One systemic and another one is local. Best Regards, Swapnil |
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ElMaestro ★★★ Denmark, 2011-07-19 15:02 (5458 d 19:07 ago) @ swapnil.kuche Posting: # 7220 Views: 3,003 |
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Hello Swapnil, ❝ One product is modified release oral solid and another one is transdermal patch. ❝ We are targeting to get approval only for delivery system. Drug is already available as generic. ❝ 1) Extended release tablets 2) Transdermal patches. ❝ One systemic and another one is local. (Transdermal, as I understand it: Drug goes through the skin, into the blood stream. Thereby not local.) Anyways, if you try to get approval for a delivery system without a drug then the system is a medical device. But how you can do that with a tablet or a patch is beyond me to understand. For US you will be looking at 510(k) clearance, for EU it involves CE marking and national approvals. I have a feeling you are actually targeting approval for the delivery system in a fashion where it comes with a drug; as such it is likely to be a generic, meaning 505(j) US or 10.1/2 in the EU. If you system allows adjustment of total dose or other tricks it is 10.3. Standard guidelines apply. — Pass or fail! ElMaestro |
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