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Back to the forum  Query: 2017-11-24 05:47 UTC (UTC+2h)
 
Salunke
Junior

India,
2017-09-13 07:56

Posting: # 17805
Views: 918
 

 Tizanidine BA BE study [R for BE/BA]

Hi

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.
ElMaestro
Hero

Denmark,
2017-09-13 08:39

@ Salunke
Posting: # 17806
Views: 785
 

 Required pilot?

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.
Salunke
Junior

India,
2017-09-13 09:14
(edited by Ohlbe on 2017-09-13 09:58)

@ ElMaestro
Posting: # 17807
Views: 774
 

 Required pilot?

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

I am pharma background person doing job with pharmaceutical company as a clinical research associate.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]
jag009
Hero

NJ,
2017-09-15 03:49

@ Salunke
Posting: # 17810
Views: 662
 

 Tizanidine BA BE study

» 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.

What do you mean required or not? What's your definition of a pilot study?

J
Ajit Thorat
Junior

India,
2017-09-22 05:38

@ Salunke
Posting: # 17823
Views: 547
 

 Tizanidine BA BE study

» 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.

yes required. pilot study gives you clear idea about your formulation before pivotal study initation. it reduces chances of pivotal study failure
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