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Back to the forum  2018-06-22 02:38 CEST (UTC+2h)

Required pilot? [Design Issues]

posted by ElMaestro - Denmark, 2017-09-13 10:39  - Posting: # 17806
Views: 2,094

Hello Salunke,

» Can you tell me about tizanidine HCL Capsule 6 mg BA/BE pilot study will be required or not. if required please let me know the reason.

You lost me - I am not aware of any product in any jurisdiction for which a pilot trial is necessary as per any guidance. Indeed it may be a good idea to conduct a pilot in some cases depending on what your uncertainty is. You/Sponsor runs the risk associated with doing or not doing a pilot.
A pilot trial will not generally affect the patient's risk.

Can you put other words to your question or tell what your background for asking is?

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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