Drugs From Discovery to Approval

ISBN-10: 047019510X

ISBN-13: 9780470195109

Edition: 2nd 2009

Authors: Rick Ng

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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.
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Book details

List price: $113.95
Edition: 2nd
Copyright year: 2009
Publisher: John Wiley & Sons, Incorporated
Publication date: 12/3/2008
Binding: Hardcover
Pages: 480
Size: 6.00" wide x 9.50" long x 1.00" tall
Weight: 1.760
Language: English

Rick Ng, PhD, has worked for more than twenty-five years in senior management positions in the private sector pharmaceutical industry. He is currently a director at a biopharmaceutical manufacturing facility in Singapore. He has provided technical training for graduate and postgraduate personnel.

Preface
Introduction
Aim of This Book
An Overview of the Drug Discovery and Development Process
The Pharmaceutical Industry
Economics of Drug Discovery and Development
Trends in Drug Discovery and Development
Case Study #1
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Drug Discovery: Targets and Receptors
Drug Discovery Processes
Medical Needs
Target Identification
Target Validation
Drug Interactions with Targets or Receptors
Enzymes
Receptors and Signal Transduction
Assay Development
Case Study #2
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Drug Discovery: Small Molecule Drugs
Introduction
Irrational Approach
Rational Approach
Antisense Approach
RNA Interference Approach
Chiral Drugs
Closing Remarks
Case Study #3
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Drug Discovery: Large Molecule Drugs
Introduction
Vaccines
Antibodies
Cytokines
Hormones
Gene Therapy
Stem Cells and Cell Therapy
Case Study #4
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Drug Development and Preclinical Studies
Introduction
Pharmacodynamics
Pharmacokinetics
Toxicology
Animal Tests, In Vitro Assays, and In Silico Methods
Formulations and Delivery Systems
Nanotechnology
Case Study #5
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Clinical Trials
Definition of Clinical Trial
Ethical Considerations
Clinical Trials
Regulatory Requirements for Clinical Trials
Role of Regulatory Authorities
Gene Therapy Clinical Trial
Case Study #6
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Regulatory Authorities
Role of Regulatory Authorities
US Food and Drug Administration
European Medicines Agency
Japan's Ministry of Health, Labor and Welfare
China's State Food and Drug Administration
India's Central Drugs Standard Control Organization
Australia's Therapeutics Goods Administration
Canada's Health Canada
Other Regulatory Authorities
Authorities Other than Drug Regulatory Agencies
International Conference on Harmonization
World Health Organization
Pharmaceutical Inspection Cooperation Scheme
Case Study #7
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Regulatory Applications
Introduction
Food and Drug Administration
European Union
Japan
China
India
Australia
Canada
Case Study #8
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Good Manufacturing Practice: Regulatory Requirement
Introduction
United States
Europe
International Conference on Harmonization
Core Elements of GMP
Selected GMP Systems
The FDA's New cGMP Initiative
Case Study #9
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Good Manufacturing Practice: Drug Manufacturing
Introduction
GMP Manufacturing
GMP Inspection
Manufacture of Small Molecule APIs (Chemical Synthesis Methods)
Manufacture of Large Molecule APIs (Recombirant DNA Methods)
Finished Dosage Forms
Case Study #10
Summary of Important Points
Review Questions
Brief Answers and Explanations
Further Reading
Future Perspectives
Past Advances and Future Challenges
Small Molecule Pharmaceutical Drugs
Large Molecule Biopharmaceutical Drugs
Traditional Medicine
Individualized Medicine
Gene Therapy
Cloning and Stem Cells
Old Age Diseases and Aging
Lifestyle Drugs
Performance-Enhancing Drugs
Chemical and Biological Terrorism
Transgenic Animals and Plants
Antimicrobial Drug Resistance
Regulatory Issues
Intellectual Property Rights
Bioethics
Concluding Remarks
Case Study #11
Further Reading
History of Drug Discovery and Development
Early History of Medicine
Drug Discovery and Development in the Middle Ages
Foundation of Current Drug Discovery and Development
Beginnings of Modern Pharmaceutical Industry
Evolution of Drug Products
Further Reading
Cells, Nucleic Acids, Genes, and Proteins
Cells
Nucleic Acids
Genes and Proteins
Further Reading
Selected Drugs and Their Mechanisms of Action
A DHFR Plasmid Vector
Vaccine Production Methods
Pharmacology/Toxicology Review Format
Examples of General Biomarkers
Toxicity Grading
Health Systems in Selected Countries
Acronyms
Glossary
Index
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