Solving the challenges of clinical drug testing

In pharmacokinetic studies, bioanalysis method validation is crucial to minimizing random error and systematic bias, which ensures quality of analytical results. Bioanalytical method validation is a controlled procedure that comprises all the vital steps to establish that a certain method is capable of producing accurate, dependable and reproducible results that are appropriate for a specific analytical application.

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Featured resources

How can a MSIA pipette tip selectively capture your trace target protein from a complex sample? 

Learn about new sample preparation technologies for improved peptide quantitation to simplify bioanalysis of proteins.

HRAM, the next generation mass spectrometry for quantitative bioanalysis. High-throughput methods for quantitation of biotherapeutics by both intact protein and proteolytic peptides.

Workflow for Therapeutic Antibodies: Qualitative, Quantitative, and Functional Verification Data from HR/AM Detection of Intact, Reduced, and Peptide-level Forms of Adalimumab

The biopharmaceutical industry has adopted biologics as a major component of their drug portfolios and developing pipelines. At the forefront of this drug class are monoclonal antibodies (mAb), highly discriminative molecules that can be engineered for specific targets.

Clinical scientist Lewis Couchman, King’s College Hospital, London, presents applications of MSIA for solving challenging protein quantitation problems in clinical research to overcome traditional immunoassay pitfalls.

LC-MS/MS Method for the Determination of Raloxifene and its Glucuronide Metabolites from Human Plasma Using SPE Micro Elution

Raloxifene, a non-steroidal selective estrogen receptor regulator, is currently applied to both the prevention and treatment of postmenopausal osteoporosis. It acts as an estrogen agonist in bone and liver, and in this way, increases bone mineral density and decreases levels of LDL-cholesterol.

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