A generic bioanalytical method development strategy and fit-for-purpose qualification to support hERG in vitro sample...

Area of Science:

• Analytical Chemistry
• Pharmacology
• Drug Development

Background:

• Analytical laboratories face challenges in determining the scope of method development and assay validation for in vitro sample analysis.
• Regulatory guidance on the extent of assay development and validation for these studies is limited.
• A 'fit-for-purpose' strategy is needed to address the analysis of buffer samples from safety pharmacology hERG studies.

Purpose of the Study:

• To describe an efficient 'fit-for-purpose' approach for analyzing buffer samples from safety pharmacology hERG studies.
• To streamline the analytical process for in vitro samples.
• To support regulatory hERG studies with reliable data.

Main Methods:

• Utilized compound modeling software to minimize method development.
• Employed generic High-Performance Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (HPLC-MS/MS) analytical systems.
• Implemented simple qualification procedures for assay evaluation before sample analysis.

Main Results:

• Significantly reduced method development efforts.
• Enabled 'one-off' analyses with validated performance.
• Demonstrated the utility of generic analytical systems and modeling software.

Conclusions:

• The developed approach provides an efficient process for analyzing in vitro samples.
• The method allows for speedy and confident data generation to support regulatory hERG studies.
• This strategy avoids the extensive workload associated with full validation procedures.