General Principles to Justify Plant Biostimulant Claims.

The forthcoming European Union (EU) Fertilizing Products Regulation proposes a claim-based definition of plant biostimulants, stipulating that "plant biostimulant" means a product stimulating plant nutrition processes independently of the product's nutrient content, with the aim of improving one or more of the following characteristics of the plant: nutrient use efficiency, tolerance to abiotic stress, crop quality traits or availability of confined nutrients in the soil and rhizosphere. The future regulation also specifies that a plant biostimulant "shall have the effects that are claimed on the label for the plants specified thereon." This creates an onus for manufacturers to demonstrate to regulators and customers that product claims are justified.

PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies.

During the development of any PEGylated protein or peptide, toxicology in relevant species will be conducted prior to human exposure. Normally, comprehensive metabolism data accompany the toxicity studies for a small molecule. We have examined whether such studies would be relevant in the safety assessment of PEGylated material.

A tiered approach to systemic toxicity testing for agricultural chemical safety assessment.

A proposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studies are scientifically appropriate and necessary without being redundant, and that tests emphasize toxicological endpoints and exposure durations that are relevant for risk assessment. The ACSA Systemic Toxicity Task Force proposes an approach to systemic toxicity testing as one part of the overall assessment of a compound's potential to cause adverse effects on health.

Cardiac safety strategies. 25-26 October 2005, the Radisson SAS Hotel, Nice, France.

This meeting was organised by IIR Life Sciences. It was chaired by Brian Guth, (head of General Pharmacology at Boehringer Ingelheim Pharma) and brought together scientists and clinicians from the pharmaceutical industry, university and regulatory agencies. The meeting presented emerging trends in cardiac safety, including its regulatory context pertaining to ICH S7A, S7B and E14.