Please ensure Javascript is enabled for purposes of website accessibility
top of page
Search

Illustrated Example for n=1 Clinical Protocol




Click below for download:


Illustrated Example_N=1 Clinical Protocol
.
Download • 155KB

Disclaimer: This document is the work product of the N=1 Collaborative (the “N1C”), and is offered as an example only. The N1C is not providing legal or regulatory advice for N=1 trials. This document should not be construed as legal or regulatory advice for any particular purpose. Any future use of this document should be tailored to specific trials based, for example, on pre-clinical data ASO chemistry and mechanism, patient disease, and evolving body of knowledge, and where appropriate, should separately be subjected to legal review.

32 views

IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations Draft Guidance for Industry December 2021

Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Co

bottom of page