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AAPS Workshop Report on ICH M10.

Brian Booth¹, Faye Vazvaei², Eric Fluhler³

¹Office of Translational Sciences, Office of Clinical Pharmacology, CDER, US FDA, Silver Spring, Maryland, USA.

The AAPS Journal

|December 12, 2019

Summary

This summary is machine-generated.

The International Council for Harmonization (ICH) released a draft guideline (M10) for bioanalytical method validation (BMV) to harmonize global pharmaceutical submissions. A workshop identified areas for discussion and potential revisions to the draft BMV guideline.

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Area of Science:

Pharmaceutical Science
Regulatory Science
Analytical Chemistry

Background:

Global pharmaceutical development faces challenges due to differing bioanalytical method validation (BMV) regulatory guidelines worldwide.
The International Council for Harmonization (ICH) aims to standardize pharmaceutical development and registration processes.
ICH released a draft guideline (M10) for BMV to address harmonization needs.

Framework:

The draft ICH M10 guideline provides a comprehensive framework for bioanalytical method validation.
The guideline addresses key aspects of BMV for global pharmaceutical submissions.
Harmonization of BMV is crucial for efficient and consistent drug development.

Implementation:

The American Association of Pharmaceutical Scientists (AAPS) convened a workshop to discuss the draft ICH M10 guideline.
Regulatory, industry, and academic scientists participated in the forum.
The workshop facilitated a discussion of various perspectives on the draft guideline's content.

Implications:

While the draft ICH M10 guideline is generally well-received, specific topics require further discussion and potential revision.
The workshop generated recommendations for the expert working group (EWG) responsible for the guideline.
Addressing these points will contribute to a more refined and globally accepted BMV standard.