Robust, fit-for-purpose method transfer: why we should apply equivalence testing

Area of Science:

• Bioanalytical Chemistry
• Pharmaceutical Development
• Regulatory Science

Background:

• Method transfer is critical for advancing drug candidates through development.
• Robust bioanalytical methods are essential for successful transfers, allowing minor deviations while preserving core principles.
• Current regulatory guidance offers limited direction on experimental design and evaluation for method transfer.

Purpose of the Study:

• To provide an overview of existing approaches for bioanalytical method transfer.
• To propose a standardized framework for evaluating data equivalence during method transfer.
• To offer guidance for the bioanalytical community on best practices for efficient method transfer.

Main Methods:

• Utilizing mutually prepared and analyzed quality controls (QCs) to assess data equivalence.
• Analyzing incurred samples at both the sending and receiving laboratories.
• Employing statistical equivalence testing to evaluate the comparability of results.

Main Results:

• Demonstrated the importance of maintaining fundamental method principles during transfer.
• Highlighted the necessity of rigorous statistical evaluation for data equivalence.
• Identified limitations in current regulatory guidelines for method transfer protocols.

Conclusions:

• A structured approach to method transfer, including robust QC and incurred sample analysis, ensures data integrity.
• Statistical equivalence testing is vital for confirming successful bioanalytical method transfer.
• Further development of regulatory guidance is needed to support efficient and reliable method transfers in drug development.