A Novel LC-MS/MS Assay for Quantifying Dermatan Sulfate as a Cerebrospinal Fluid Biomarker for Mucop
Accumulation of dermatan sulfate (DS) in tissue and body fluid leads to mucopolysaccharidosis II (MPS II) disorder. The study aims to develop an LC-MS/MS assay to measure DS in human cerebrospinal fluid (CSF) as a biomarker.
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The US Food and Drug Administration (FDA) issued new draft guidance in December 2016 indicating that generic manufacturers can demonstrate bioequivalence for a specific semi-solid dosage form using predictive in vitro testing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.