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SearchRequired pilot? [Design Issues]
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?
» 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?
—
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.
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.
Complete thread:
- Tizanidine BA BE study - Salunke, 2017-09-13 09:56 [Design Issues]
![[Mix]](http://static.bebac.at/img/mix.png "Open in mix view")
- Required pilot? - ElMaestro, 2017-09-13 10:39
- Required pilot? - Salunke, 2017-09-13 11:14
- Tizanidine BA BE study - jag009, 2017-09-15 05:49
- Tizanidine BA BE study - Ajit Thorat, 2017-09-22 07:38
- Required pilot? - ElMaestro, 2017-09-13 10:39
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