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Salunke ☆ India, 2017-09-13 11:56 (2407 d 14:05 ago) Posting: # 17805 Views: 7,101 |
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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. Edit: Category changed; see also this post #1. [Helmut] |
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ElMaestro ★★★ Denmark, 2017-09-13 12:39 (2407 d 13:22 ago) @ Salunke Posting: # 17806 Views: 6,086 |
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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? — Pass or fail! ElMaestro |
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Salunke ☆ India, 2017-09-13 13:14 (2407 d 12:46 ago) @ ElMaestro Posting: # 17807 Views: 5,965 |
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❝ 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] |
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jag009 ★★★ NJ, 2017-09-15 07:49 (2405 d 18:12 ago) @ Salunke Posting: # 17810 Views: 5,867 |
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❝ 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 |
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Ajit Thorat ☆ India, 2017-09-22 09:38 (2398 d 16:22 ago) @ Salunke Posting: # 17823 Views: 5,815 |
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❝ 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 |
Ing. Helmut Schütz