The IPEC Safety Guide for Pharmaceutical Excipients issued in November 2021. The guide was designed to give an overview on recommended toxicological studies for different therapeutic applications, routes of administration and treatment periods. Toxicological safety studies described in this guide are intended for consideration by excipient manufacturers who market excipients for use in drug formulations and excipient users who conduct toxicology studies required for the initial approval of a novel excipient in a drug formulation. Excipient users formulating an excipient beyond its approved, prior use are responsible for conducting the appropriate safety studies.
At the time of publication of the guide, with the exception of a pilot program for novel excipients review recently introduced by the US FDA, there is no independent review of novel excipients. This guide is intended to provide information to assist in determining the level of safety information necessary to support the use of a novel excipient, taking into account that depending on the type of novel excipient, different levels of safety information may be required.
The Guide addresses several routes of administration for novel excipients and intended use in special patient populations when specific considerations are required to assess potential excipient safety concerns such as: pediatric safety, endocrine activity, nano character and biological occurrence. In addition, several recent New Approach Methods (NAMs) are discussed to introduce the global emergence of alternative in silico and in vitro methods to complement traditional in vivo approaches. These approaches are being used to employ a Weight-of-Evidence (WoE) approach to demonstrate the safety of novel excipients consistent with the growing regulatory commitment to reduce animal testing in safety assessments.
This webinar will highlight key sections from the guide.
Learning / Awareness Objectives
During this webinar, participants will learn how the guide evolved from articles published by IPEC-Americas and IPEC Europe in 1996 and 1997, respectively, to the current content, topics and safety practice recommendations.
The webinar will cover safety considerations based on:
> degree of excipient novelty
> duration of intended human exposure
> route(s) of administration
> patient population
> therapeutic application
> special considerations
> alternative methods