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Article
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat
In-clinic dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer’s disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a potential al...
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Article
A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials
In-clinic venous dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer’s disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a poten...
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Protocol
Intact Mass Quantitation of Therapeutic Antibodies for Pharmacokinetic Studies Using Immuno-Purification
The quantitation of therapeutic antibodies by mass spectrometry often utilizes a surrogate peptide approach following enzymatic digestion of the antibody. Although this approach has been widely adopted, it is ...
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Article
Open AccessAn Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs
Dried blood spot (DBS) sample collection has gained increased interest across the pharmaceutical industry as a potential alternative to plasma for pharmacokinetic (PK) evaluations. However, regulatory guidelin...
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Article
Open AccessDesaturation index versus isotopically measured de novo lipogenesis as an indicator of acute systemic lipogenesis
High carbohydrate feeding is known to increase plasma triglycerides as well as hepatic de novo lipogenesis (DNL) and may be implicated in the development of hepatic insulin resistance and fatty liver. Unfortunate...
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Article
Quantitative-qualitative data acquisition using a benchtop orbitrap mass spectrometer
Current approaches to discovery-stage drug metabolism studies (pharmacokinetics, microsomal stability, etc. ) typically use triple-quadrupole-based approaches for quantitative analysis. This necessitates the o...
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Protocol
Glycoprotein Analysis by Capillary Zone Electrophoresis-Electrospray Mass Spectrometry
The study of glycoproteins as intact molecules or as smaller fragments generated by chemical or enzymatic digestion is well suited to the technique of capillary zone electrophoresis-electrospray mass spectrome...
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Article
Development of generic liquid chromatography-mass spectrometry methods using experimental design
Standard approaches to development of liquid chromatography-mass spectrometry (LC-MS) methods, either ion-pairing or reversed-phase liquid chromatography, have been through trial and error or intentional varia...
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Article
Electrochemical properties of capillary electrophoresis-nanoelectrospray mass spectrometry
Electrochemical properties are inherent to the techniques of electrophoresis and electrospray ionization. Interfacing capillary zone electrophoresis (CZE) with electrospray mass spectrometry (ESMS) can lead to...
