The principles of comparability assessments have been accepted globally as offering sensitive and reliable tools with which to evaluate potential changes to biologics that may arise either through processing changes or through the creation of a copy (biosimilar) by a different sponsor. The comparability approach has evolved through systematic advances in four areas: clear and convergent guidelines for evaluation of potential changes to biologics; risk-based systems of weighting analytical data; progressive improvements in analytical methods; and advanced understanding of post-translational modifications. Routine regulatory expectations for clinical equivalence data are being reevaluated, as they seldom contribute to the assessment of similarity.
View Article and Find Full Text PDFAdvancing care delivery in lifestyle medicine and primary care has increasingly benefited from unique data sources and points. To remain competitive and relevant in modern practice, physicians and health systems must tackle and engage the implementation of big data and advanced applications for increasingly complex care. In many cases, information is being aggregated, though barriers exist in terms of accessing, interpreting, and making it actionable.
View Article and Find Full Text PDFThe prospect of recreating the complex structural hierarchy of protein folding in synthetic oligomers with backbones that are artificial in covalent structure ("foldamers") has long fascinated chemists. Foldamers offer complex functions from biostable scaffolds and have found widespread applications in fields from biomedical to materials science. Most precedent has focused on isolated secondary structures or their assemblies.
View Article and Find Full Text PDFA variety of oligomeric backbones with compositions deviating from biomacromolecules can fold in defined ways. Termed "foldamers," these agents have diverse potential applications. A number of protein-inspired secondary structures (e.
View Article and Find Full Text PDFObjective: To establish a dosing regimen for potassium bromide and evaluate use of bromide to treat spontaneous seizures in cats.
Design: Prospective and retrospective studies.
Animals: 7 healthy adult male cats and records of 17 cats with seizures.