Poster: Determination of Pregabalin in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry
Pregabalin, (S)-3-(aminomethyl)-5-methylhexanoic acid, is an analogue of the neurotransmitter gamma amino butyric acid (GABA). It is used for the treatment of peripheral and central neuropathic pain in adults and as an adjunctive therapy for refractory partial seizures. Pregabalin binds potently to the α2δ (alpha2delta) subunit of the voltage-dependent calcium channel in the central nervous system and its binding at this site reduces calcium influx at the nerve terminal, leading to the release of several neurotransmitters, such as glutamate and noradrenalin. The aim of this study is to develop a sensitive, specific, robust and rapid LC-MS/MS method: Use simple extraction procedure; With no interference from matrix; With short run time.
Poster: Development and Validation of an Ultra Sensitive LC-MS/MS Method for Quantitation of Midazolam in Human Plasma
Midazolam is a widely used central nervous system depressant. It is used for the treatment of insomnia, seizure, and induction of sedation or amnesia for operations. Midazolam is metabolized by cytochrome CYP3A. It is a widely used probing drug for evaluation of CYP3A activity in drug-to-drug interaction (DDI) studies.
White Paper: Developing and Demonstrating Bioequivalence of Semi-Solid Dosage Forms
The US Food and Drug Administration (FDA) issued new draft guidance in December 2016 indicating that generic manufacturers can demonstrate bioequivalence for a specific semi-solid dosage form using predictive in vitro testing as a surrogate for in vivo testing.
Case Study: Development of a Neutralizing Antibody Assay to support Clinical Trials
Sponsor required development of a Neutralizing Antibody (NAB) method for an antibody drug that interrupts a Ligand: Receptor interaction.Previous attempts to develop a Cell-Based NAB had been unsuccessful and current attempts to develop a Competitive Ligand Binding assay were also having difficulty with method sensitivity, reproducibility and drug tolerance. Pipeline progression for this asset was halted until these issues could be resolved.
Assay List: Frontage Laboratories Biomarker Assay List – April 2019
Frontage’s Bioanalytical Team is highly experienced in developing, qualifying and validating Biomarker assays. We can apply traditional and newer ELISA platforms as well as ultra-sensitive detection capabilities (Quanterix Simoa) for quantitation in the femtogram/mL range including single and multiplex analysis in various disease categories. Check out our updated list of Biomarker Assays.