Bioequivalence and Bioavailability Forum

kvgreddy06 ☆ India, 2013-12-25 11:16 (4566 d 01:32 ago) Posting: # 12105 Views: 3,601	steady state [Design Issues] Post reply
	Dear All, i need a steady state study templet of protocol (BABE), can i expect.. Thanking u... Edit: Unlinked from an unrelated thread and category changed. See also this post. [Helmut]

Helmut
★★★

Vienna, Austria,
2013-12-25 14:53
(4565 d 21:54 ago)

@ kvgreddy06
Posting: # 12106
Views: 3,019

Protocol templates

Post reply

Hi kvgreddy06,

❝ i need a steady state study templet of protocol (BABE),

The worst protocols I have seen resulted from unreflecting use of templates. Design your study according to the requirements of the specific drug/formulation, keeping the guidelines in mind. Then start typing.

❝ can i expect..

No. Even if you opt for a template, you have to write it yourself based on all conditions and procedures of the CRO. I would not recommend copy/pasting from another one.

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steady state [Design Issues]

Protocol templates