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, Zinc oxide, 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

Seong Soo A An,1 Meyoung-Kon Kim2 1Department of Bionanotechnology, Gachon Medical Research Institute, Gachon University, Seongnam, Gyeonggi, Korea; 2Department of Biochemistry and Molecular Biology, Korea University Medical School and College, Seoul, KoreaThe current volume is a special issue focusing on a safety assessment of nanoparticles, from their physicochemical properties to government regulations. It features twenty-five papers, discussing general issues with the possible harmfulness of two different types of nanoparticles (NPs); silica (SiO2) and zinc oxide (ZnO). Six papers describe detailed analyses from 90-day repeated administrations of NPs, and finally there is a series of technical reports, formatted by the National Toxicology Program (NTP), dealing with safety issues regarding international cooperation with the OECD (Organisation for Economic Co-operation and Development) Working Party on Manufactured Nanomaterials (WPMN).

At head of title: Department of Commerce. Bureau of Standards. ; "Issued July 3, 1922." ; Mode of access: Internet.

1st edition issued with title : Recommended specifications for . ; At head of title: Department of Commerce. Bureau of Standards. ; "Issued July 3, 1922." ; Federal Specifications Board standard specification no. 9 ; Mode of access: Internet.

Department of Chemistry, Anil Neerukonda Institute of Technology and Sciences, Sangivalasa, Visakhapatnam-531 162, Andhara Pradesh, India E-mail : siva_ks9123@rediffmail.com Department of Chemistry, Government College (Autonomous), Rajahmundry-533 105, Andhra Pradesh, India E-mail : drrrvanka99@yahoo.com School of Chemistry, Andhra University, Visakhapatnam-530 003, Andhra Pradesh, India E-mail : gollapallinr@yahoo.com Manuscript received online 05 January 2013, revised 17 May 2013, accepted 03 July 2013 The photocatalytic degradation of Congo Red, an azo dye has been investigated in presence of aqueous suspension of ZnO under visible light irradiation. ZnO was impregnated with Ag of varying concentrations such as 0.5, 1.0, 1.5 atom percentage and the samples were calcined at different temperatures for 2 h. The catalyst was characterized by XRD. The photocatalytic activity of ZnO was found to be enhanced by silver impregnation and 1 atom percent of silver-impregnated ZnO has high photocatalytic activity. Calcination of samples at higher temperature decreased the photocatalytic activity. The effect of various process parameters such as catalyst loading, initial concentration of dye and pH of the solution has been investigated. The kinetics of dye degradation was also studied and the data were well fitted to pseudo-first order kinetic model.