Sorry – wrong addressee [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2024-07-24 15:31 (302 d 16:47 ago) – Posting: # 24099
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Hi QA,

❝ ❝ IMHO, such a product is a mere marketing gimmick.❝

❝ Thank you for your HO. Let the BD and marketing team take the call.

Sure. At the end of the day the ‘Guy in the Armani suit’ decides.

❝ Allow me to ask the same question. As a strategy to register this product in EU, what is your suggestion?

I’m not the best person to support something that I cannot scientifically defend.
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.
🙈 🙉 🙊
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Helmut Schütz
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