HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions.

A multi-sector study (i.e., Ring Trial) was designed to improve the in vitro detection of N-nitrosamine (NA)-associated mutagenicity by optimizing the bacterial reverse mutation (i.

Comprehensive safety and toxicity analysis of 2,2'-Bipyridine derivatives in combating MRSA biofilm formation and persistence.

Introduction: Methicillin-resistant (MRSA) infections have become arduous to treat due to their capacity to form biofilms, develop persistence, and exhibit significant antimicrobial resistance. These factors contribute to the complexity of managing MRSA infections and highlight the urgent need for innovative treatment strategies.

Objectives: This endeavor aims to evaluate the safety of 2,2'-Bipyridine (2,2'-Bipy) derivatives and their antimicrobial, anti-biofilm, and anti-persister activities in treating MRSA Infections.

Perspectives, Experiences, and Opportunities of Academic Surgeons in the Era of Health Care Corporatization.

Objective: To characterize contemporary surgeons' viewpoints and perspectives on the academic mission during health care corporatization.

Background: Academic surgery, traditionally driven by the tripartite missions of excellence in clinical care, scientific research, and education, faces increasing challenges from a corporatized health care environment. While previous studies have addressed the financial aspects of corporatization, a comprehensive evaluation of academic surgeons' attitudes and experiences remains lacking.

N-Nitrosamine drug substance related impurities (NDSRIs) - A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da.

The carcinogenicity potency categorization approach (CPCA) derived and harmonized by Health Authorities was a significant milestone, as it defined molecular properties that allowed for the rapid evaluation of the chemical structures of N-nitrosamine drug substance related impurities (NDSRIs) and the assignment of associated lifetime Acceptable Intake (AI) limits to inform on appropriate impurity control strategies in certain drug products. Nonetheless, it is important to continue to refine and improve on the CPCA based upon data-derived evidence. Herein, we focus on the default CPCA AI for NDSRIs, which is largely based on the small molecule N-nitrosamines (NAs).

Safety assessment of protein A and derivation of a parenteral health-based exposure limit.

Protein A (PA) is a bacterial cell wall component of Staphylococcus aureus whose function is to bind to Immunoglobulin G (IgG). Given its ability to bind IgG as well as its stability and resistance to harsh acidic and basic cleaning conditions, it is commonly used in the affinity chromotography purification of biotherapeutics. This use can result in levels of PA being present in a drug product and subsequent patient exposure.