Saturday, January 01, 2011
This paper addresses the use of radiolabeled compounds in clinical
research, in particular the considerations involved in regulatory
submissions where radiolabeled compounds are used.
The purpose of this paper is to lay out the regulatory considerations related to the choice of starting materials and synthetic route for an API.
This paper provides a recommendation for selection of long-term stability conditions for submission of room temperature storage drug products in Zone IV countries in the face of a confusing mixture of expectations from international regulatory bodies...