Utility of High Throughput Screening Techniques to Predict Stability of Monoclonal Antibody Formulations During Early Stage Development.

Selecting optimal formulation conditions for monoclonal antibodies for first time in human clinical trials is challenging due to short timelines and reliance on predictive assays to ensure product quality and adequate long-term stability. Accelerated stability studies are considered to be the gold standard for excipient screening, but they are relatively low throughput and time consuming. High throughput screening (HTS) techniques allow for large amounts of data to be collected quickly and easily, and can be used to screen solution conditions for early formulation development.

Psychometric evaluation of the Energy Conservation Strategies Survey.

Objective: To examine the internal consistency and test-retest reliability of the Energy Conservation Strategies Survey (ECSS), a tool that was specifically designed to determine if people with multiple sclerosis who attended the six-week energy conservation course actually implemented the strategies taught to them.

Design: The instrument ECSS was administered at six weeks and seven weeks post intervention to evaluate the test-retest reliability, while data from six weeks post intervention were utilized to assess the internal consistency of the ECSS.

Setting: Community locations in Illinois and Minnesota, USA.