TSD only an option in ex­ceptional cases [Two-Stage / GS Designs]

posted by Dr_Dan  – Germany, 2015-06-02 10:00 (3541 d 11:43 ago) – Posting: # 14891
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Dear all,
Thank you very much for the effort you spent to teach me where the pitfalls of a TSD study lie. Fortunately in vain (not the teaching but I just heard that the project is cancelled. I guess performing a study with a supposed CVintra of 50% for AUC and 80% for Cmax is only interesting from a scientific point of view). As you know I am not a friend of TSD and this discussion confirmed my antipathy. IMHO as long as you have a "normal" drug substance you should go with an accepted design. I would use a full replicate design with the possibility to widen the acceptance range (at least for Cmax). The savings in terms of money of a TSD (if any!) do no justify the risks.
Kind regards and thanks again
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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