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.
STABILITY TESTING AS A QUALITY CONTROL MEASURE white paper
Stability testing is, in essence, a quality control process and is therefore a vital component of every phase of clinical development for both large and small molecules – from early phase through to and including post approval. It should be treated as an ongoing program rather than as a periodic exercise.
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.