Thursday, January 20, 2022 9:00 am to 11:00 am EST
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