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, ipamorelin acetate, 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: 5U01FD005946

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, sermorelin acetate, 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: 5U01FD005946

1. Frontiers Between Theory and Industrial Practice in Vinyl Acetate Polymerizations -- 2. The Polymerization of Aqueous Solutions of Vinyl Acetate -- 3. Effects of Particle Number and Initiator Level on the Kinetics of Vinyl Acetate Emulsion Polymerizations -- 4. Synthesis Kinetics and Characterization of Poly(Vinyl Acetate)- Molecular Weight and Long Chain Branching Development -- 5. Some Surface Chemical Effects on the Capture of Free Radicals-A Kinetic Parameter Analysis of the LPS Model -- 6. The Reinvestigation of Vinyl Acetate Emulsion Polymerization (I)- The Rate of Polymerization -- 7. The Reinvestigation of Vinyl Acetate Emulsion Polymerization (II)-The Induced Decomposition of Initiator -- 8. The Reinvestigation of Vinyl Acetate Emulsion Polymerization (III)-Isotope Effect -- 9. The Radiation Induced Emulsion Polymerization of Vinyl Acetate -- 10. The Stabilization of Poly(Vinyl Acetate) Latexes by Polymethacrylic Acid -- 11. Particularities of Emulsion Polymerization of Vinyl Acetate in the Presence of Hydroxyethylcellulose -- 12. Preparation, Characterization and Properties of Vinyl Acetate- Butyl Acrylate Copolymer Latexes -- 13. Some Studies on Vinyl Acrylic Latex-Surfactant Interactions.

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, vitamin A acetate, 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: 2U01FD005946