IPEC Federation Publishes Revised Safety Guide for Pharmaceutical Excipients

BIG NEWS!!! IPEC has just published an updated Safety Guide for Pharmaceutical Excipients which can help excipient companies develop Novel Excipients and assist pharma companies in using Novel Excipients in their drug applications.

I have been involved with a great international team within IPEC made up of hard-working, world class toxicologists and regulatory experts who have been working on this Guide for over a year. We believe that this guide will be helpful to drive drug product innovation and assist companies who want to participate in the new FDA Novel Excipient Review Pilot Program which was recently launched by FDA.

The guide includes information which will help determine the amount of safety data that is needed depending the type of Novel Excipient and the intended use of the excipient and provides ideas for how to use some of the newer tools available for safety evaluations beyond animal studies.

The Guide is available only to IPEC members for the next three months and then it will become publicly available for free to the industry to assist in pharmaceutical and excipient development.

If you would like any help in using this Guide to help you with your excipient safety assessments or Novel Excipient Development projects, please let me know.

See the Press release below for more information!!

IPEC Federation Publishes Revised Safety Guide | IPEC-AMERICAS (ipecamericas.org)