Suchergebnisse

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, Diclofenac sodium, were summarized in this report. ; U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946

Diclofenac is a worldwide consumed drug included in the watch list of substances to be monitored according to the European Union Water Framework Directive (Directive 2013/39/EU). Aerobic granular sludge sequencing batch reactors (AGS-SBR) are increasingly used for wastewater treatment but there is scant information on the fate and effect of micropollutants to nutrient removal processes. An AGS-SBR fed with synthetic wastewater containing diclofenac was bioaugmented with a diclofenac degrading bacterial strain and performance and microbial community dynamics was analysed. Chemical oxygen demand, phosphate and ammonia removal were not affected by the micropollutant at 0.03 mM (9.54 mg L-1). The AGS was able to retain the degrading strain, which was detected in the sludge throughout after augmentation. Nevertheless, besides some adsorption to the biomass, diclofenac was not degraded by the augmented sludge given the short operating cycles and even if batch degradation assays confirmed that the bioaugmented AGS was able to biodegrade the compound. The exposure to the pharmaceutical affected the microbial community of the sludge, separating the two first phases of reactor operation (acclimatization and granulation) from subsequent phases. The AGS was able to keep the bioaugmented strain and to maintain the main functions of nutrient removal even through the long exposure to the pharmaceutical, but combined strategies are needed to reduce the spread of micropollutants in the environment. ; info:eu-repo/semantics/acceptedVersion

Correspondence to the Editor. ; Of the sixteen Old World vultures, 81% are globally threatened or near-threatened; four vulture species inhabit Europe, of which three are threatened or near-threatened. Since 1993, the EU and various national governments have invested significant financial resources in the conservation of vultures — including at least 76 LIFE projects related to these species — and between 1993 and 2014 spent €121.9 million, of which €59.7 million came from European funds. During this period, Spain, home to 90% of all European vultures, invested €72.8 million (€30.8 million received from EU) on 38 projects related to vulture conservation. ; Peer reviewed

This study investigates the effects of environmental parameters such as UV intensity (X-1, 2.1 similar to 6.3 mW/cm(2)), Fe(III) (X-2, 0 similar to 0.94 mg/L), NO3- (X-3, 0 similar to 20 mg/L) and humic acid (X-4, 0 similar to 30 mg/L) on the removal efficiency of diclofenac (DCF, Y), and optimization using a response surface methodology (RSM) based on Box-Behnken design (BBD). According to analysis of variance and t-test results (p < 0.001), the proposed quadratic BBD model based on a total of 29 experimental runs fitted well to the experimental data. Moreover, the determination coefficient (R-2 = 0.990) and adjusted determination coefficient (R-a(2) = 0.981) indicated that this model is adequate with a high goodness-of-fit. Variables of X-1, X-2 and X-3 had significant positive contributions (p < 0.001), while X-4 had significant negative contribution to the DCF removal (p < 0.001). A Pareto analysis showed that X-4 was the most important factor (57.18%) in DCF photolytic removal. The predicted and observed DCF removal were 94.98 and 94.2% under optimal conditions (X-1 = 6.29 mW/cm(2), X-2 = 0.75 mg/L, X-3 = 15.65 mg/L and X-4 = zero), respectively. The RSM not only gives valuable information on the interactions between these photoreactive species (UV intensity, Fe(III), NO3-, and humic acid) that influence DCF removal, but also identifies the optimal conditions for effective DCF removal in water. ; This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korean Government (MEST) (No. 2010-0014222). ; OAIID:oai:osos.snu.ac.kr:snu2013-01/102/0000005866/2 ; SEQ:2 ; PERF_CD:SNU2013-01 ; EVAL_ITEM_CD:102 ; USER_ID:0000005866 ; ADJUST_YN:Y ; EMP_ID:A072570 ; DEPT_CD:903 ; CITE_RATE:1.122 ; FILENAME:첨부된 내역이 없습니다. ; DEPT_NM:환경보건학과 ; EMAIL:zohkd@snu.ac.kr ; SCOPUS_YN:N ; CONFIRM:Y

n this paper, the detection protocols for the selective and simultaneous determination of diclofenac (DCF) and tetracycline (TC) in aqueous solutions were developed using a commercial boron-doped diamond electrode modified with graphene oxide and silver, as the Ag/GF/BDD electrode. This electrode presented the possibility to detect only DCF and TC selectively by applying amperometric techniques. However, the pulsed voltammetric techniques operated in optimized working conditions allowed the selective/simultaneous detection of DCF and TC characterized by the improvement of the performance parameters compared to CV. Following the research study related to the electrochemical detection application of the two emerging target pollutants (DCF and TC), the Ag/GF/BDD electrode presented good stability and reproducibility of the results obtained.