Drugs
John Wiley & Sons Inc (Verlag)
978-0-471-60150-0 (ISBN)
- Titel erscheint in neuer Auflage
- Artikel merken
Statistics show that out of five thousand compounds with initial promise, five will go into human clinical trials, and only one will become an approved drug. This tiny fraction illustrates the huge complexities involved in bringing a drug to market, a process that brings together scientific research, medical ethics, business, and various regulatory agencies. "Drugs: From Discovery to Approval" presents a clear, step-by-step overview of the entire process. Using simple language, this comprehensive guide introduces basic concepts, then moves on to discuss disease target selection and the discovery processes for both small and large molecule drugs. Subsequent chapters explain preclinical studies, clinical trials, regulatory issues, good manufacturing practices (GMPs), and perspectives on the future. The coverage also includes: a helpful listing of current FDA and European guidelines; a special section on regulatory authorities and processes in Japan and China; rich illustrations throughout, including more than ninety figures and tables; useful appendices on the history of drug discovery and development; and, representative examples of drug mechanisms in action.
Written for professionals in the pharmaceutical industry, and readily accessible for students of pharmacy or medicine and others interested in drug discovery, "Drugs: From Discovery to Approval" represents a practical and approachable reference on this important process.
Rick Ng, Ph.D., has worked for more than 20 years in senior management positions in the private sector. He is currently a senior manager at a biopharmaceutical manufacturing facility in Singapore. He has provided technical training for graduate and post-graduate personnel.
Preface. Chapter 1. Introduction. Chapter 2. Drug Discovery: Targets and Receptors. Chapter 3. Drug Discovery: Small Molecule Drugs. Chapter 4. Drug Discovery: Large Molecule Drugs. Chapter 5. Drug Development and Preclinical Studies. Chapter 6. Clinical Trials. Chapter 7. Regulatory Authorities. Chapter 8. Regulatory Applications. Chapter 9. Good Manufacturing Practice: Regulatory Requirements. Chapter 10. Good Manufacturing Practice: Drug Manufacturing. Chapter 11. Future Perspectives. Appendix 1. History of Drug Discovery and Development. Appendix 2. Cells, Nucleic Acids, Genes, and Proteins. Appendix 3. Selected Drugs and Their Mechanisms of Action. Appendix 4. Pharmacology/Toxicology Review Format. Acronyms. Glossary. Index.
| Erscheint lt. Verlag | 29.1.2004 |
|---|---|
| Zusatzinfo | glossary |
| Verlagsort | New York |
| Sprache | englisch |
| Maße | 162 x 242 mm |
| Gewicht | 652 g |
| Einbandart | gebunden |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| Medizin / Pharmazie ► Pharmazie | |
| Technik | |
| ISBN-10 | 0-471-60150-0 / 0471601500 |
| ISBN-13 | 978-0-471-60150-0 / 9780471601500 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
| Haben Sie eine Frage zum Produkt? |
aus dem Bereich
