No abstract

There is a paucity of quantitative impact assessments of the sectorial and macroeconomic impacts of CAP budget reform for EU member states. To fill this gap, the current study employs a sophisticated agricultural variant of the GTAP model to evaluate the recently agreed CAP spending limits for the financial period 2014–2020 as well as a more radical 50% cut to the CAP budget proposed by the UK government. The study incorporates methodological innovation in terms of the modelling of CAP budgetary mechanisms. Furthermore, official EU auditing statistics are employed to (i) greatly improve the existing representation of agricultural support payments in the GTAP benchmark data and (ii) implement a detailed contemporary CAP baseline for member states to capture both the decoupled/coupled split of support payments and the distribution of support across both ‘pillars’. In general, CAP expenditure cuts have muted impacts on EU and world agricultural markets; whereas changes in net transfer payments have implications for real income and macro trade balances in EU member states. This observation is particularly pertinent when assessing conciliatory reductions in the UK rebate in exchange for deeper CAP budget cuts

Brivaracetam is a novel high-affinity SV2A ligand currently in clinical development for epilepsy. The objective was to characterize its disposition in patients with renal impairment. A single oral dose of 200 mg brivaracetam was administered to 9 patients with severe renal impairment not requiring dialysis (creatinine clearance <15 mL/min, n = 6; 15-29 mL/min, n = 3) and 9 matched healthy controls. Plasma and urinary concentrations of brivaracetam and 3 pharmacologically inactive metabolites (acid, hydroxy, and hydroxyacid) were determined up to 72 hours postdose, and noncompartmental pharmacokinetic parameters were derived. The C(max) of brivaracetam was unchanged relative to healthy controls, whereas AUC was slightly increased (mean ratio, 1.21; 90% confidence interval, 1.01-1.45). Nonrenal and renal clearances of brivaracetam decreased from 47 and 4.5 to 41 and 1.7 mL/min/1.73 m(2). Exposure to the acid, hydroxy, and hydroxyacid metabolites was markedly increased: C(max) by 2.4-, 2.0-, and 11.7-fold and AUC by 3.2-, 4.1-, and 21.5-fold. Renal clearance of these rapidly cleared metabolites was decreased 10-fold in patients with severe renal impairment. Nonclinical toxicology studies concluded to the absence of safety issues related to the increased levels of metabolites. These observations suggest that dose adjustment of brivaracetam should not be required at any stage of renal dysfunction.

In the summer of 2014 Russia imposed a ban on most agri-food products from countries enforcing Ukraine-related sanctions against Russia. We use a specific factors computable general equilibrium (CGE) model to simulate the short-run impact of this retaliatory policy. The baseline is carefully designed to isolate the impacts of the ban on the European Union (EU), Russia itself and a selection of key trade partners. The modelling of the ban follows a novel approach, where it is treated as a loss of established trade preferences via reductions in consumer utility in the Armington import function. Not surprisingly, the results indicate that Russia bears the highest income loss (about €3.4 billion) while the EU recovers part of its lost trade through expansion of exports to other markets. An ex-post comparison between simulation results and observed trade data reveals the model predictions to be broadly accurate, thereby validating the robustness of the modelling approach.

Following intensive discussions, review, alignment of procedures and multiple surveys among their member companies, the European Bioanalysis Forum (EBF) is providing a recommendation on how to integrate incurred sample reproducibility (ISR) in the bioanalytical process. The recommendation aims to provide guidance throughout the lifecycle of a validated method, including the application of the method in study support. In its recommendation, the EBF considers both the internal discussions with EBF member companies, as well as the input provided in international meetings where ISR was discussed. The ultimate goal of the EBF recommendation is to ensure that bioanalytical methods can provide accurate and reproducible concentration data for pharmacokinetic and/or toxicokinetic evaluation, without any compromise, while safeguarding the optimal use of laboratory resources.