The Predictive Safety Testing Consortium: safety bio-markers, collaboration, and qualification

The Predictive Safety Testing Consortium: safety bio- markers, collaboration, and qualification

The Predictive Safety Testing Consortium (PSTC) is one of nine consortia comprising the Critical Path Institute (C-Path), a non-profit organisation launched in 2005 and dedicated to playing the role of a catalyst in the development of new approaches that advance medical innovation and regulatory science. C-Path achieves this by leading teams that share data, knowledge and expertise resulting in...

Review of Qualification Data for Biomarkers of Nephrotoxicity Submitted by the Predictive Safety Testing Consortium

Bio-markers: traceability in food safety issues.

Research and practice are focusing on development, validation and harmonization of technologies and methodologies to ensure complete traceability process throughout the food chain. The main goals are: scale-up, implementation and validation of methods in whole food chains, assurance of authenticity, validity of labelling and application of HACCP (hazard analysis and critical control point) to t...

Relationship between Assertiveness and physician-nurse collaboration with Safety Culture

Introduction and Aims: Improving patient safety is one of the main pillars of health services. On the other hand, the professional communication between the health team members and some personality characteristics of nurses, such as Assertiveness, can affect the quality of services provided to the patient. Therefore, this study aimed to determine how safety culture is associated with nurse-phys...

The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path.

The qualification of biomarkers of drug safety requires data on many compounds and nonclinical and clinical studies. The cost and effort associated with these qualifications cannot be easily covered by a single pharmaceutical company. Intellectual property associated with safety biomarkers is also held by many different companies. Consortia between different pharmaceutical companies can overcom...