Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Food and Drug Administration pharmaceuticals

United States Food and Drug Administration Pharmaceutical Research and... [Pg.75]

US Food and Drug Administration, Pharmaceutical current good manufacturing practices (cGMPs) for the 21st century - a risk-based approach final report, 2004. [Pg.70]

U.S. Department of Health and Human services, U.S. Food and Drug Administration, Pharmaceutical cGMPs for the 21st century—A risk -based approach, Final Report— Fall 2004, September 2004, available http //www.fda.gov/cder/gmp/gmp2004/GMP finalreport2004.htm, accessed Dec. 5,2006. [Pg.237]

Current Good Manufacturing Practices for Finished Pharmaceuticals, U.S. Food and Drug Administration, 21 CFR 210 and 211... [Pg.284]

The hundreds of different pharmaceutical agents approved for use by the U.S. Food and Drug Administration come from many sources (see the Chapter 5 Focus On). Many drugs are isolated directly from plants or bacteria, and others are made by chemical modification of naturally occurring compounds, but an... [Pg.320]

For food and pharmaceutical applications, the microbial count must be reduced to less than 10,000 viable cells per g exopolysaccharide. Treatment with propylene oxide gas has been used for reducing the number of viable cells in xanthan powders. The patented process involves propylene oxide treatment for 3 h in a tumbling reactor. There is an initial evacuation step before propylene oxide exposure. After treatment, evacuation and tumbling are alternated and if necessary the reactor is flushed with sterile nitrogen gas to reduce the residual propylene oxide level below the Food and Drug Administration permitted maximum (300 mg kg 1). The treated polysaccharide is then packaged aseptically. [Pg.211]

The file may be queried In response to questions from clinical staff at the National Institutes of Health and physlr-clans and laboratory scientists throughout the country who submit their problems by letter or telephone The file has been used to provide Information for a pharmaceutical manufacturing company preparing a new drug application to the Food and Drug Administration For the latter organlzatloi the file has been... [Pg.282]

For pharmaceutical products, the synthesis route is usually established very early on because of drug registration procedures carried out with governmental agencies, e.g. the Food and Drug Administration (FDA). [Pg.196]

A guideline for evaluation of the photostability of new drug substances and dosage forms was published in 1997 [39]. Subsequently, a joint study was undertaken by the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America to evaluate the ICF1 guideline. A draft chapter for the United States Pharmacopeia, based on the guideline and the joint study, has been published in Pharmacopeial Forum [40]. [Pg.151]

The 1997 Food and Drug Administration Modernization Act (FDAMA) specifically recognizes the right of a licensed pharmacist to compound pharmaceutical products in response to, or in anticipation of an appropriate prescription. The Act also authorized the establishment of an FDA Expert Advisory Committee... [Pg.757]

Food and Drug Administration, HHS, International Conference on Harmonisation Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals availability. Notice, Fed. Regist., 71, 19193,2006. [Pg.18]


See other pages where Food and Drug Administration pharmaceuticals is mentioned: [Pg.455]    [Pg.233]    [Pg.438]    [Pg.386]    [Pg.455]    [Pg.233]    [Pg.438]    [Pg.386]    [Pg.1944]    [Pg.1970]    [Pg.203]    [Pg.164]    [Pg.767]    [Pg.406]    [Pg.258]    [Pg.1085]    [Pg.70]    [Pg.114]    [Pg.1533]    [Pg.380]    [Pg.3]    [Pg.5]    [Pg.7]    [Pg.24]    [Pg.346]    [Pg.747]    [Pg.750]    [Pg.777]    [Pg.820]    [Pg.215]    [Pg.264]    [Pg.167]    [Pg.71]    [Pg.17]    [Pg.41]    [Pg.11]    [Pg.201]    [Pg.9]    [Pg.186]    [Pg.349]    [Pg.518]   
See also in sourсe #XX -- [ Pg.9 ]

See also in sourсe #XX -- [ Pg.248 ]




SEARCH



Food Drug Administration

Food and Drug Administration drugs

Food and Drug Administration foods

Food and drugs administration

Pharmaceutical drugs

© 2024 chempedia.info