Enhancing data standards to advance translation in spinal cord injury.

Data standards are available for spinal cord injury (SCI). The International SCI Data Sets were created in 2002 and there are currently 27 freely available. In 2014 the National Institute of Neurological Disorders and Stroke developed clinical common data elements to promote clinical data sharing in SCI.

Total joint replacement of the lumbar spine: report of the first two cases with 16 years of follow-up.

Background: Total joint replacement (TJR) of the lumbar spine is a revolutionary procedure that couples the clinical benefits of neural decompression with preservation of natural motion and sagittal balance at the operative level. The TJR procedure involves reconstruction of the entire motion segment using a posterior bilateral transforaminal approach to access the disc space. The TJR implant (MOTUS, 3Spine, Chattanooga, TN, USA) replaces the function of the intervertebral disc and facet joints, performing biomechanically as a new articulation for the resected, degenerated disc and facets.

Enzyme-mediated drug-drug interactions: a review of and methodologies, regulatory guidance, and translation to the clinic.

Enzyme-mediated pharmacokinetic drug-drug interactions can be caused by altered activity of drug metabolizing enzymes in the presence of a perpetrator drug, mostly inhibition or induction. We identified a gap in the literature for a state-of-the art detailed overview assessing this type of DDI risk in the context of drug development. This manuscript discusses and methodologies employed during the drug discovery and development process to predict clinical enzyme-mediated DDIs, including the determination of clearance pathways, metabolic enzyme contribution, and the mechanisms and kinetics of enzyme inhibition and induction.