Making methods rugged for regulated bioanalysis
Related Experiment Video
Updated: Apr 13, 2026

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification
Published on: August 17, 2015
Steve Unger1, Thomas Horvath, Melvin Tan
1Worldwide Clinical Trials, Early Phase Services, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA.
Abstract:
Methods started in discovery are optimized as they progress through preclinical and clinical development. Making a robust assay includes testing individual steps for consistency and points of failure. Assays may be transferred, optimized and revalidated several times. A rugged assay will not only meet regulatory requirements, but will execute with a low failure rate and confirm results under repeat analysis. Challenging aspects such as differential recovery, sample stabilization, resolution of isomers or conjugate analysis must be tackled and made routine. The proper selection of the IS can overcome limitations. It is best to know the potential points of failure before a study has started, but lessons learned from each study also provide invaluable insights to improve assay ruggedness.
More Related Videos
07:43Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
Published on: July 14, 2023
09:32Procedure and Key Optimization Strategies for an Automated Capillary Electrophoretic-based Immunoassay Method
Published on: September 10, 2017
Related Concept Videos
Data Validation
Key parameters for method validation include:
Bioavailability Study Design: Single Versus Multiple Dose Studies
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Bioavailability Study Design: Healthy Subjects Versus Patients
Measurement of Bioavailability: Pharmacodynamic Methods
Measurement of Bioavailability: Pharmacokinetic Methods