Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based...

Area of Science:

• Pharmacokinetics
• Pharmacodynamics
• Regulatory Science

Background:

• A joint meeting was held by the Association of the British Pharmaceutical Industry (ABPI) and Medicines and Healthcare products Regulatory Agency (MHRA) under the Ministerial Industry Strategy Group (MISG).
• The meeting focused on physiologically based pharmacokinetic modeling and simulation (PBPK), specifically its clinical applications in regulatory submissions.
• International experts from industry, academia, and regulatory bodies attended.

Purpose of the Study:

• To explore the application of PBPK modeling and simulation in regulatory submissions from a European perspective.
• To discuss topics complementary to those addressed at a prior US Food and Drug Administration (FDA) meeting.
• To summarize the outcomes and identify key considerations for PBPK use in European regulatory processes.

Main Methods:

• A collaborative meeting format was employed, bringing together diverse stakeholders.
• Discussions were structured around the clinical component of regulatory applications utilizing PBPK.
• The focus was on European regulatory viewpoints and requirements.

Main Results:

• Key discussion points and outcomes regarding the use of PBPK in regulatory applications were identified.
• The report highlights the European regulatory perspective on PBPK implementation.
• Areas for future development and harmonization were implicitly or explicitly addressed.

Conclusions:

• PBPK modeling and simulation hold significant potential for enhancing regulatory applications in Europe.
• Further dialogue and collaboration are crucial for optimizing the use of PBPK in regulatory decision-making.
• The meeting successfully provided a platform for discussing the European regulatory landscape for PBPK.