Extractables and Leachables in Early Phase Development

 

 

By Wayland Rushing, Ph.D.

 

Over the last couple of decades we have observed ever increasing expectations for extractables and leachables.  Initially this was focused on the final container/closure systems of inhalation products, which quickly expanded to parenterals and ophthalmics.   Over the last few years the expectations have continued to expanding including additional expectations for dermal products, veterinary products and manufacturing equipment.  The media coverage surrounding Bisphenol A and recalls involving popular medications due to leachables has helped to drive extractables and leachables into regulatory and public crosshairs.

 

Recently a new trend has been encountered during early phase development.  Drug sponsors have been required by regulatory authorities to provide detailed E&L packages and address specific questions during phase I/II.  Several of these sponsors have reported being placed on a clinical hold until the information is provided.  This can be of concern for many companies as the typical E&L program can be a time-consuming and expensive endeavor and most have not planned on this requirement in their development plans. 

 

Coming in September, I will be presenting a webinar which will discuss the overall regulatory trends being observed and how to establish an appropriate early phase E&L program for to avoid delays in early phase development. 

Please let me know your thoughts on the continued increasing expectations or if you would like more information on the upcoming webinar.