The New Medicines: How Drugs are Created, Approved, Marketed, and Sold
Autor Bernice Z. Schacteren Limba Engleză Hardback – 29 dec 2005 – vârsta până la 17 ani
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Specificații
ISBN-13: 9780275981419
ISBN-10: 027598141X
Pagini: 280
Dimensiuni: 156 x 235 x 25 mm
Greutate: 0.57 kg
Editura: Bloomsbury Publishing
Colecția Praeger
Locul publicării:New York, United States
ISBN-10: 027598141X
Pagini: 280
Dimensiuni: 156 x 235 x 25 mm
Greutate: 0.57 kg
Editura: Bloomsbury Publishing
Colecția Praeger
Locul publicării:New York, United States
Notă biografică
Bernice Schacter Ph.D., has over 25 years of biomedical research experience in both academia and industry. She served on the faculty of the School of Medicine of Case Western Reserve University and conducted immunology research at Bristol-Myers Squibb Company. She also served as Vice President of Research at BioTransplant, Inc., a biotechnology startup company in Boston, MA. She has published over 50 papers in peer-reviewed journals and is a co-inventor on four issued patents. Since 1994 she has been a biomedical consultant and writer. She has taught immunology to undergraduate, graduate, and medical students and has developed and offered biotechnology courses for liberal studies students at Wesleyan University in Connecticut and at the University of Delaware.
Cuprins
List of IllustrationsPrefaceAbbreviations and AcronymsThe Path from Bench to BedsideHow did the FDA get to be in charge? The History of Human DrugsThe Eureka Moment: How New Medicines Are DiscoveredTest Tube Results Are Not Enough - Animal Tests for a Drug's UtilityThe Business Decisions - Committing to DevelopmentProduction of the New DrugLaboratory and Animal Safety TestingGetting Set for Clinical TrialsPhase 1 Clinical TrialsPhase 2 Clinical TestingPhase 3 TestingPutting Together the Application for Approval: The New Drug Application (NDA)Now Everybody Holds Their Breath (and some people may brush up on the rules for insider trading) - Will the FDA File the NDA?The FDA ReviewWhat do outside experts think? The Advisory Committee Meeting and FDA ApprovalThe Launch: Marketing the DrugIt's Not Over Till It's Over: Post Approval StudiesAre we well served?