Predictive Dissolution Models for Surrogate Release: An Industry Position

Presented by: IQ Dissolution Working Group
Sponsored by: IQ Drug Product Leadership Group

In vitro dissolution testing is commonly performed to ensure that oral solid dosage medicines are of high quality and will achieve their targeted in vivo performance. However, this testing is time and material-consuming. Therefore, pharmaceutical companies have been developing predictive dissolution models (PDMs) for drug product release based on fast at- and/or on-line measurements. Recently, PDMs have seen acceptance by major regulatory bodies as release tests for the dissolution critical quality attribute.

This webinar will describe several methodologies to develop and validate a fit-for-purpose model, then to implement it as a surrogate release test for dissolution. These approaches will be exemplified by real-life case studies, which demonstrate that PDMs for release are not only viable but more sustainable than in vitro dissolution testing and can significantly accelerate drug product release. The rise of continuous manufacturing within the pharmaceutical industry further favors the implementation of real-time release testing. Therefore, a steep uptake of PDMs for release is expected once this methodology is globally accepted. To that end, it is advantageous for global regulators and pharmaceutical innovators to coalesce around a harmonized set of expectations for the development, validation, implementation, and lifecycle of PDMs as part of drug product release testing.

SPEAKERS/MODERATORS

• Tessa Carducci, PhD, Merck & Co., Inc.
• Melanie Dumarey, PhD, AstraZeneca
• Himanshu Gandhi, Bristol-Myers Squibb
• Sarah Nielsen, PhD, Johnson & Johnson
• Yanmei Lan, PhD, Takeda
• Ana Filipa Tavares da Silva, PhD, Janssen Pharmaceutica NV
• Nikolay Zaborenko, PhD, Eli Lilly & Co.

Attendance is limited. Register today!

This is a public webinar. Membership in IQ Consortium is not required to attend.