Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study.

With the discovery of carcinogenic nitrosamine impurities in pharmaceuticals in 2018 and subsequent regulatory requirements for risk assessment for nitrosamine formation during pharmaceutical manufacturing processes, storage or from contaminated supply chains, effective testing of nitrosamines has become essential to ensure the quality of drug substances and products. Mass spectrometry has been widely applied to detect and quantify trace amounts of nitrosamines in pharmaceuticals. As part of an effort by regulatory authorities to assess the measurement variation in the determination of nitrosamines, an inter-laboratory study was performed by the laboratories from six regulatory agencies with each of the participants using their own analytical procedures to determine the amounts of nitrosamines in a set of identical samples.

A novel device for serial venous blood sampling in a canine model.

Diagnostic serial venous blood sampling has the potential to introduce stress-related artifactual elements into the analytical results. We have evaluated the use of a wearable automated serial blood sampling device in a canine model that obviates a need for multiple manual venipuncture. Efficacy in measuring cortisol levels during prolonged serial blood sampling is described.

Intervertebral disc temperature mapping during disc biacuplasty in the human cadaver.

Background: Intradiscal biacuplasty (IDB) is a novel heating therapy using cooled radiofrequency (RF), which may offer relief for discogenic pain. Effective neuroablation may be achieved intradiscally at higher lesion temperatures. The safety of intradiscal heating at elevated temperatures using cooled RF has never been reported.

The effect of nanotopography on modulating protein adsorption and the fibrotic response.

Understanding and modulating the cellular response to implanted biomaterials is crucial for the field of tissue engineering and regenerative medicine. Since cells typically reside in an extracellular matrix containing nanoscale architecture, identifying synthetic nanostructures that induce desirable cellular behaviors could greatly impact the field. Using nanoimprint lithography, nanostructured patterns were generated on thin film polymeric materials.

Evaluation of gastropexy and stoma tract maturation using a novel introducer kit for percutaneous gastrostomy in a porcine model.

Background: Fluoroscopic placement of percutaneous gastrostomy (PG) requires the use of T-bar fasteners to affix the stomach to the anterior abdominal wall; the effect of T-fasteners on stoma tract maturation is unknown. The authors studied PG stoma tract maturation, comparing PG + gastropexy with standard percutaneous endoscopic gastrostomy (PEG).

Methods: Sixteen pigs underwent PG placement using a novel introducer kit.