Bioequivalence and Bioavailability Forum • Pathfinder study

Imran
☆

Mumbai,
2007-07-04 11:48
(6935 d 21:45 ago)

Posting: # 862
Views: 4,093

Pathfinder study [Regulatives / Guidelines]

Dear PK Colleagues

I have one querry. If a pilot study is planned with 12 or 18 subjects. If the study is pass, :-)

can the same study can be submitted to regulatory authority. I think non of the guidlines say to conduct the pivotal study, however it shold have sufficient numbers of subject to get atleast 80 % power.

Even I came to known about a term 'pathfinder study' concepts in US. where they do the pilot study and if results are promising, the same study is submitted to authority. :love:

I will be thankful if some of u can share ur experience in the issue.

Thanking u in anticipation

—
Dr.Imran Khan

hitesh shah ☆ India, 2007-07-05 10:05 (6934 d 23:28 ago) @ Imran Posting: # 865 Views: 3,141	Pathfinder study Post reply
	Dear Imran, I think you can submit the study if you are fullfilling the following criteria: 1. The test production batch fulfill the GMP and GCP guideline requirement (generally not the case). 2. Reference product selected as per the requirement of Regulatory agency. 3. Conduct of the study as per the guideline of intended Regulatory submission. Regards Hitesh Shah