Integrated Cardiac Safety
| Autor: | J. Rick Turner, Todd A. Durham |
|---|---|
| EAN: | 9780470411285 |
| eBook Format: | |
| Sprache: | Englisch |
| Produktart: | eBook |
| Veröffentlichungsdatum: | 26.11.2008 |
| Untertitel: | Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance |
| Kategorie: | |
| Schlagworte: | FDA FDA approval adverse drug reactions cardiac safety profile drug development drug development stages drug discovery drug regulation postmarketing research |
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The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.
J. Rick Turner, PhD, PGCE, MICR, is Chairman, Department of Clinical Research at Campbell University School of Pharmacy. Dr. Turner has extensive teaching, research, and pharmaceutical credentials and more than a dozen awards and honors, including a Commit to Product Development Award from GlaxoSmithKline. He is the author of seven books and more than 100 journal articles and published abstracts. Todd A. Durham, MS, is Senior Director of Biostatistics and Data Management at Inspire Pharmaceuticals. Prior to joining Inspire, Mr. Durham served as Associate Director of Biostatistics at Quintiles, Inc. Mr. Durham has made significant statistical contributions to six NDA submissions and has been involved with five presentations to FDA advisory committees.
J. Rick Turner, PhD, PGCE, MICR, is Chairman, Department of Clinical Research at Campbell University School of Pharmacy. Dr. Turner has extensive teaching, research, and pharmaceutical credentials and more than a dozen awards and honors, including a Commit to Product Development Award from GlaxoSmithKline. He is the author of seven books and more than 100 journal articles and published abstracts. Todd A. Durham, MS, is Senior Director of Biostatistics and Data Management at Inspire Pharmaceuticals. Prior to joining Inspire, Mr. Durham served as Associate Director of Biostatistics at Quintiles, Inc. Mr. Durham has made significant statistical contributions to six NDA submissions and has been involved with five presentations to FDA advisory committees.
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