Drugs (eBook)
368 Seiten
John Wiley & Sons (Verlag)
978-0-471-72279-3 (ISBN)
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.
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
* 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.
"...ideal for researchers who want a basic, unadorned
presentation of drug research and development." (Journal of
Clinical Research Best Practices, October 2007)
"...a concise, no-nonsense overview of drug research and
development from target identification to product manufacturing."
(Journal of Clinical Research Practices, October 2007)
"...an exciting and novel text...excellent and
essential text..." (Journal of Chemical Technology and
Biotechnology, Vol. 80 (8), August 2005)
"...an exciting and novel text ...provides a
concise, yet comprehensive survey of the entire drug development
process." (Journal of Chemical Technology and
Biotechnology, 2005; Vol. 80, 964-965)
"...a practical reference source on this important
process." (Journal of the National Medical
Association, Vol.97, No.3, March 2005)
"...this book is appealing...the information...should
provide a greater understanding of social and ethical concerns
regarding modern medications in a complex world." (Journal of
Pharmacy Technology, November/ December 2004)
"...a concise guide to the subject...readable and clearly
written...can be recommended for the general reader..."
(Pharmaceutical Journal, 24 April 2004)
| Erscheint lt. Verlag | 11.3.2005 |
|---|---|
| Sprache | englisch |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| Medizin / Pharmazie ► Pharmazie | |
| Technik | |
| Wirtschaft | |
| Schlagworte | Biotechnologie i. d. Biowissenschaften • Biotechnology • Biowissenschaften • Chemie • Chemistry • Life Sciences • Medical Science • Medizin • Pharmaceutical & Medicinal Chemistry • Pharmacology & Pharmaceutical Medicine • Pharmakologie • Pharmakologie u. Pharmazeutische Medizin • Pharmazeutische u. Medizinische Chemie |
| ISBN-10 | 0-471-72279-0 / 0471722790 |
| ISBN-13 | 978-0-471-72279-3 / 9780471722793 |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
| Haben Sie eine Frage zum Produkt? |
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