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RegisterRequired pilot? [Design Issues]
Hello Salunke,
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?
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Tizanidine BA BE study Salunke 2017-09-13 09:56 [Design Issues]
![[Mix]](https://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
Ing. Helmut Schütz