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RegisterSorry – wrong addressee [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2024-07-24 15:31 (252 d 16:23 ago) – Posting: # 24099
Views: 2,308
Hi QA,
To give you an example: I was once asked by an innovator to develop the concept for a modified (i.e., prolonged) release formulation of a drug with a half-life of > 48 hours, which is only administered chronically. Doesn’t make any sense – a clear case of evergreening. BE of MR is much more difficult than the one of IR.
Not my circus, not my monkeys. I refused.
🙈 🙉 🙊
❝ ❝ IMHO, such a product is a mere marketing gimmick.❝
❝ Thank you for your HO. Let the BD and marketing team take the call.
❝ Allow me to ask the same question. As a strategy to register this product in EU, what is your suggestion?
To give you an example: I was once asked by an innovator to develop the concept for a modified (i.e., prolonged) release formulation of a drug with a half-life of > 48 hours, which is only administered chronically. Doesn’t make any sense – a clear case of evergreening. BE of MR is much more difficult than the one of IR.
Not my circus, not my monkeys. I refused.
🙈 🙉 🙊
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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Ing. Helmut Schütz