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Back to the forum  Query: 2017-11-23 19:26 CET (UTC+1h)
 

Required pilot? [R for BE/BA]

posted by ElMaestro - Denmark, 2017-09-13 10:39  - Posting: # 17806
Views: 778

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?

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

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