Drugs From Discovery to Approval

ISBN-10: 0471601500
ISBN-13: 9780471601500
Edition: 2004
Authors: Rick Ng
List price: $88.50
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Description: This volume offers a 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 manufacturing of  More...

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Book details

List price: $88.50
Copyright year: 2004
Publisher: John Wiley & Sons, Incorporated
Publication date: 1/2/2004
Binding: Hardcover
Pages: 368
Size: 6.25" wide x 9.25" long x 1.00" tall
Weight: 1.430
Language: English

This volume offers a 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 manufacturing of drugs.

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
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
Further Reading
Drug Discovery: Small Molecule Drugs
Introduction
Irrational Approach
Rational Approach
Antisense Approach
Chiral Drugs
Closing Remarks
Further Reading
Drug Discovery: Large Molecule Drugs
Introduction
Vaccines
Antibodies
Cytokines
Hormones
Gene Therapy
Stem Cells
Further Reading
Drug Development and Preclinical Studies
Introduction
Pharmacodynamics
Pharmacokinetics
Toxicology
Animal Tests, In Vitro Assays and In Silico Methods
Formulations and Delivery Systems
Further Reading
Clinical Trial
Definition of Clinical Trial
Ethical Considerations
Clinical Trials
Regulatory Requirements for Clinical Trials
Role of Regulatory Authorities
Gene Therapy Clinical Trial
Further Reading
Regulatory Authorities
Role of Regulatory Authorities
US Food and Drug Administration
European Agency for the Evaluation of Medicinal Products
Japan's Ministry of Health, Labour and Welfare
China's State Drug Administration
Other Regulatory Authorities
Authorities other than Drug Regulatory Agencies
International Conference on Harmonization
World Health Organization
Pharmaceutical Inspection Cooperation Scheme
Further Reading
Regulatory Applications
Introduction
Food and Drug Administration
European Union
Japan
China
Further Reading
Good Manufacturing Practice: Regulatory Requirements
Introduction
United States
Europe
International Conference on Harmonization
Core Elements of GMP
Selected GMP Systems
The FDA's New cGMP Initiative
Further Reading
Good Manufacturing Practice: Drug Manufacturing
Introduction
GMP Manufacturing
GMP Inspection
Manufacture of Small Molecule APIs
Manufacture of Large Molecule APIs
Finished Dosage Forms
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 Animal and Plants
Regulatory Issues
Intellectual Property Rights
Concluding Remarks
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
Pharmacology/Toxicology Review Format
Acronyms
Glossary
Index

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