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The AAPS Journal

, 20:60 | Cite as

Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report

  • Andreas Abend
  • Tycho Heimbach
  • Michael Cohen
  • Filippos Kesisoglou
  • Xavier Pepin
  • Sandra Suarez-Sharp
Meeting Report Theme: Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development
Part of the following topical collections:
  1. Theme: Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development

Abstract

On May 15th–17th, 2017, the US FDA and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) held a workshop at the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI), to discuss the role of dissolution testing and translational modeling and simulation in enabling patient-centric solid oral drug product development. This 3-day event was attended by scientists from regulatory agencies, pharmaceutical companies, and academia. The workshop included podium presentations followed by breakout session discussions. The first day of the meeting focused on the challenges in dissolution method development and the role of dissolution testing throughout drug product development. On the second day, approaches to establish a link between in vitro testing and in vivo drug product performance (e.g., systemic exposure) were presented. Overall success rates and challenges in establishing IVIVCs via traditional and modern physiologically based pharmacokinetic (PBPK) modeling and simulation approaches were discussed. Day 3 provided an opportunity to discuss the expectations for establishing clinically relevant drug product specifications (CRDPS). It was recognized that understanding the impact of formulation and process variations on dissolution and in vivo performance is critical for most drug products formulated with poorly soluble drugs to ensure consistent product performance. The breakout sessions served as platforms for discussing controversial topics such as the clarification of dissolution terminology, PBPK model development and validation expectations, and approaches to set CRDPS. The meeting concluded with a commitment to continue the dialog between regulators, industry, and academia to advance overall product quality understanding.

KEY WORDS

clinically relevant specifications dissolution IVIVC/IVIVR PBPK modeling and simulations safe space 

Notes

Acknowledgments

The meeting organizers are indefinitely grateful to Drs. James Polli (University of Maryland, School of Pharmacy, Baltimore, MD), Tzuchi (Rob) Ju (AbbVie, Inc.), Mr. Evangelos Kotzagiorgis (EMA), and Ms. Ann Anonson (UM) for their tremendous efforts in helping in the organization of this workshop and to all speakers, facilitators, and scribes whose participation was key in having a very informative workshop.

Compliance with Ethical Standards

Conflict of Interest

The authors declare that they have no conflict of interest to declare.

Disclaimer

This article reflects the views of the authors and should not be construed to represent their organizations’ views or policies.

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  1. 1.Pharmaceutical SciencesMerckWest PointUSA
  2. 2.Novartis Institutes for Biomedical ResearchEast HanoverUSA
  3. 3.Pfizer IncGrotonUSA
  4. 4.AstraZeneca R&DCheshireUK
  5. 5.Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA

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