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.
Pre-Existing Antibodies within Immunogenicity Testing
Monoclonal antibodies and next generation molecules such as antibody-drug conjugates (ADC) are being developed and moved into early phase clinical testing. These new molecules bring challenges for measuring immunogenicity within human serum samples.
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The US Food and Drug Administration (FDA) issued new draft guidance in December 2016 indicating that generic manufacturers can demonstrate bioequivalence for a specific semi-solid dosage form using predictive in vitro testing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.
Recruiting Women for First-in-Human Trials: Tips for Success
Programs that need to include women in their FIH studies will find that successful enrollment of women is achievable; however, it requires a concerted effort, with the correct strategies and proper support. In the following pages, we explore the challenges in recruiting women for FIH studies and present a set of practices that have proven successful towards improving the recruitment rates of women for these studies.