IQ Consortium

Organization of pharmaceutical and biotechnology companies with a mission of advancing science and technology.

#Dissolution

Predictive Dissolution Models for Surrogate Release: An Industry Position

by

*New Date!*

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.

PBBM Report Template: Considerations for Improved Quality in View of Regulatory Submissions

by

Sponsored by the Regulatory Advisory Committee

Pharmaceutical innovators and generic companies employ Physiologically Based Biopharmaceutics Models (PBBMs) to inform drug product development and may be able to waive clinical pharmacokinetic studies for changes occurring both before and after product approval. The 2023 M-CERSI workshop titled “PBBM Best Practices for Drug Product Quality: Regulatory and Industry Perspectives” recognized that a standardized PBBM report template could benefit both industry stakeholders and regulatory bodies. This webinar will discuss the PBBM report template, which summarizes a set of expectations and proposes a structure for presenting input data, modeling plan, context of the model, model parameters, and clinical data on which the model was developed and validated to minimize the number of PBBM rejections in the future. Efforts have been made to align the framework presented in the PBBM report template with the overarching ICH M15 Guideline on Model Informed Drug Development (MIDD).

For further information about the PBBM report template, please refer to the publication Arora et al. Development of a Physiologically Based Biopharmaceutics Model (PBBM) Report Template: Considerations for Improved Quality in View of Regulatory Submissions. Molecular Pharmaceutics (submission in progress)