Bioequivalence and Bioavailability Forum

qualityassurance ★ 2023-10-02 14:06 (476 d 18:00 ago) Posting: # 23728 Views: 2,545	Pilot study data submission as pivotal study [Off Topic] Post reply
	Dear forum members, If pilot study passes the bio-equivalence criteria with 12 evaluable subjects, can it be submitted to the regulatory authority instead of conducting another pivotal study based on ethical reason and to avoid any unnecessary exposure of drug to healthy human subjects? Interesting to know the opinions. Thank you. Regards, QA

dshah ★★ India, 2023-10-03 18:30 (475 d 13:37 ago) @ qualityassurance Posting: # 23733 Views: 2,022	Pilot study data submission as pivotal study Post reply
	Dear QA! ❝ If pilot study passes the bio-equivalence criteria with 12 evaluable subjects, can it be submitted to the regulatory authority instead of conducting another pivotal study based on ethical reason and to avoid any unnecessary exposure of drug to healthy human subjects? If your batch size/scale remains same, was manufactured under cGMP condition, it could be used. Regards, Divyen

Pilot study data submission as pivotal study [Off Topic]