Ng, Rick Drugs From Discovery to Approval
  2. Edition - December 2008 89.90 Euro 2008. 480 Pages, Hardcover - Professional Book - ISBN-10: 0-470-19510-X ISBN-13: 978-0-470-19510-9 - John Wiley & Sons

Detailed description The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The new edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter.
From the contents PREFACE.
1 INTRODUCTION.
2 DRUG DISCOVERY: TARGETS AND RECEPTORS.
3 DRUG DISCOVERY: SMALL MOLECULE DRUGS.
4 DRUG DISCOVERY: LARGE MOLECULE DRUGS.
5 DRUG DEVELOPMENT AND PRECLINICAL STUDIES.
6 CLINICAL TRIALS.
7 REGULATORY AUTHORITIES.
8 REGULATORY APPLICATIONS.
9 GOOD MANUFACTURING PRACTICE: REGULATORY REQUIREMENT.
10 GOOD MANUFACTURING PRACTICE: DRUG MANUFACTURING.
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 A DHFR PLASMID VECTOR.
APPENDIX 5 VACCINE PRODUCTION METHODS.
APPENDIX 6 PHARMACOLOGY/ TOXICOLOGY.
REVIEW FORMAT.
APPENDIX 7 EXAMPLES OF GENERAL BIOMARKERS.
APPENDIX 8 TOXICITY GRADING.
APPENDIX 9 HEALTH SYSTEMS IN SELECTED COUNTRIES.
ACRONYMS.
GLOSSARY.
INDEX.
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