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Orphan Drugs
None
A Student's View of Education
Distributed to some depository libraries in microfiche.
The $800 Million Pill
"Goozner shows how drug innovation is driven by dedicated scientists intent on finding cures for diseases, not by pharmaceutical firms, whose bottom line often takes precedence over the advance of medicine. Stories of a university biochemist who spent twenty years searching for single blood protein that later became the best-selling biotech drug in the world, a government employee who discovered the causes for dozens of crippling genetic disorders, and the Department of Energy-funded research that made the Human Genome Project possible - these accounts illustrate how medical breakthroughs actually take place.".
Food Chemicals Codex
The Food Chemicals Codex (FCC) is a compendium of internationally recognized monograph standards and tests for the purity and quality of food ingredients, e.g., preservatives, flavorings, colourings, and nutrients. FCC standards help to ensure that products are prepared according to Good Manufacturing Practices and do not contain harmful levels of contaminants. Published since 1966, the FCC was recently acquired by USP from the Institute of Medicine.
Current Catalog
First multi-year cumulation covers six years: 1965-70.
Generic and Innovator Drugs
Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals becaus...
Searching for Magic Bullets
Searching for Magic Bullets reveals the quest of consumers, health professionals, and drug developers to find safer and faster methods of bringing new medications to the marketplace. Authors Basara and Montagne explore the current drug development and approval processes, their strengths and weaknesses, and the mechanisms by which patients and organizations evade these processes. Readers learn about the fundamentals of traditional and nontraditional drug discovery and development as they occur in the U.S., as well as the views of consumers, patients, and health professionals. Specific case studies of non-traditional drug development and acquisition strategies are highlighted, including AIDS m...
