Assessing the reliability of ecotoxicological studies : an overview of current needs and approaches

In general, reliable studies are well designed and well performed, and enough details on study design and performance are reported to assess the study. For hazard and risk assessment in various legal frameworks, many different types of ecotoxicity studies need to be evaluated for reliability. These studies vary in study design, methodology, quality, and level of detail reported (e.g., reviews, peer-reviewed research papers, or industry-sponsored studies documented under Good Laboratory Practice [GLP] guidelines). Regulators have the responsibility to make sound and verifiable decisions and should evaluate each study for reliability in accordance with scientific principles regardless of whether they were conducted in accordance with GLP and/or standardized methods. Thus, a systematic and transparent approach is needed to evaluate studies for reliability. In this paper, 8 different methods for reliability assessment were compared using a number of attributes: categorical versus numerical scoring methods, use of exclusion and critical criteria, weighting of criteria, whether methods are tested with case studies, domain of applicability, bias toward GLP studies, incorporation of standard guidelines in the evaluation method, number of criteria used, type of criteria considered, and availability of guidance material. Finally, some considerations are given on how to choose a suitable method for assessing reliability of ecotoxicity studies. Integr Environ Assess Manag 2017;13:640-651. (c) 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC

Opname van PCB's door vis in uiterwaardplassen

Veel uiterwaardplassen en andere oppervlaktewateren in Nederland worden gedomineerd door bodemwoelende vissen, zoals brasem. Door hun voedselgedrag komen deze vissen rechtstreeks in aanraking met het sediment, inclusief de daarin nog steeds aanwezige organische verontreinigingen. Ondanks het feit dat de PCB's al jaren in het sediment aanwezig zijn en wellicht met de tijd veel minder beschikbaar zijn geworden, wijzen onderzoeksresultaten erop dat de opname van PCB's uit uiterwaardsedimenten door vis nog steeds substantieel is. Tevens bleek dat de Tenax-methode een betere correlatie oplevert met PCB-opname door bodemwoelende vissen dan meting van het totaalgehalte van PCB's in sedimen

GREENER pharmaceuticals for more sustainable healthcare

This is the final version. Available on open access from the American Chemical Society via the DOI in this record. Medicines are essential to human health but can also impact the aquatic and terrestrial environment after use by patients and release via excreta into wastewater. We highlight the need for a GREENER approach to identify and meet important environmental criteria, which will help reduce the impact of medicinal residues on the environment. These criteria include effect reduction by avoiding nontarget effects or undesirable moieties, exposure reduction via lower emissions or environmental (bio)degradability, no PBT (persistent, bioaccumulative, and toxic) substances, and risk mitigation. With all of these criteria, however, patient health is of primary importance as medicines are required to be safe and efficacious for treating diseases. We discuss the feasibility of including these criteria for green by design active pharmaceutical ingredients in the process of drug discovery and development and which tools or assays are needed to accomplish this. The integrated GREENER approach can be used to accelerate discussions about future innovations in drug discovery and development.Innovative Medicines Initiative 2 Joint Undertakin