Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication.

Rationale: We recently reported two novel biomarkers for acute kidney injury (AKI), tissue inhibitor of metalloproteinases (TIMP)-2 and insulin-like growth factor binding protein 7 (IGFBP7), both related to G1 cell cycle arrest.

Objectives: We now validate a clinical test for urinary [TIMP-2]·[IGFBP7] at a high-sensitivity cutoff greater than 0.3 for AKI risk stratification in a diverse population of critically ill patients.

Development of a dye ingress method to assess container-closure integrity: correlation to microbial ingress.

To demonstrate maintenance of parenteral product sterility, container-closure integrity over the shelf life of the product is critical. In the past, sterility testing has been used to ensure closure integrity. However, because of the limitations associated with sterility testing, there is a need for an improved method for evaluating container-closure integrity.