Evaluating the "return on patient engagement initiatives" in medicines research and development: A literature review.

Background: Showing how engagement adds value for all stakeholders can be an effective motivator for broader implementation of patient engagement. However, it is unclear what methods can best be used to evaluate patient engagement. This paper is focused on ways to evaluate patient engagement at three decision-making points in the medicines research and development process: research priority setting, clinical trial design and early dialogues with regulators and health technology assessment bodies.

Patient involvement in clinical research: why, when, and how.

The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process.

Use of hydrogen peroxide-based tooth whitening products and its relationship to oral cancer.

Unlabelled: Tooth whitening products containing hydrogen peroxide or carbamide peroxide were evaluated in this review for potential oral cancer risk from their use. Hydrogen peroxide is genotoxic in vitro, but not in vivo. Hydrogen peroxide was not considered to pose a genotoxic risk to humans.

Analysis of reproductive toxicity and classification of glufosinate-ammonium.

CONCLUSION REGARDING CLASSIFICATION OF GLUFOSINATE-AMMONIUM: Science Partners' Evaluation Group (Evaluation Group) has conducted an independent analysis of the herbicide glufosinate-ammonium (GA) relative to its potential to cause reproductive toxicity in humans. Further, the Evaluation Group has evaluated the implementation of Annex 6 of Commission Directive 2001/59/EC (28th ATP of Council Directive 67/548/EEC) and Council Directive 91/414/EEC, with respect to classification of chemicals posing potential reproductive hazards. After consideration of all information available to us relevant to the potential of glufosinate-ammonium (GA) to cause reproductive toxicity, the Science Partners Evaluation Group concludes that no classification of GA is justified.

A review of the safety of DHA45-oil.

Polyunsaturated fatty acids (PUFAs), such as docosahexaenoic acid (DHA), are natural constituents of the human diet; however, dietary intakes of these fatty acids are below recommended values. The main dietary source of DHA is fatty fish, with lesser amounts provided by shellfish, marine mammals, and organ meats. The addition to traditional food products of refined oils produced by marine microalgae represents potential sources of supplemental dietary DHA.

Threshold of toxicological concern (TTC) in food safety assessment.

The threshold of toxicological concern (TTC) is a principle which refers to the possibility of establishing a human exposure threshold value for all chemicals, below which there is no appreciable risk to human health. The concept that exposure thresholds can be identified for individual chemicals in the diet is already widely embodied in practice of many regulatory bodies in setting acceptable daily intakes (ADIs) for chemicals whose toxicological profile is known. However, the TTC concept goes further than this in proposing that a de minimis value can be identified for many chemicals, including those of unknown toxicity, taking the chemical structure into consideration.

An evaluation of the possible carcinogenicity of bisphenol A to humans.

Bisphenol A (BPA) is a monomer component of polycarbonate plastics and epoxy resins. These resins are used in numerous consumer products, including food-contact plastics. There has been considerable scientific debate about the relevance to humans of reported estrogenic actions of BPA.