DRUGS
From Discovery to Approval

Drugs - From Discovery to Approval PDF Book

 CONTENTS OF THIS BOOK

CHAPTER 1
Introduction
An Overview of the Drug Discovery and Development Process
The Pharmaceutical Industry
Economics of Drug Discovery and Development
Trends in Drug Discovery and Development

CHAPTER 2
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

CHAPTER 3
Drug Discovery: Small Molecule Drugs
Introduction
Irrational Approach
Rational Approach
Antisense Approach
Chiral Drugs
Closing Remarks

CHAPTER 4
Drug Discovery: Large Molecule Drugs
Introduction
Vaccines
Antibodies
Cytokines
Hormones
Gene Therapy
Stem Cells

CHAPTER 5
Drug Development and Preclinical Studies
Introduction
Pharmacodynamics
Pharmacokinetics
Toxicology
Animal Tests, In Vitro Assays and In Silico Methods
Formulations and Delivery Systems



CHAPTER 6
Clinical Trial
Definition of Clinical Trial
Ethical Considerations
Clinical Trials
Regulatory Requirements for Clinical Trials
Role of Regulatory Authorities
Gene Therapy Clinical Trial

CHAPTER 7
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

CHAPTER 8
Regulatory Applications
Introduction
Food and Drug Administration
European Union
Japan
China

CHAPTER 9
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

CHAPTER 10
Good Manufacturing Practice: Drug Manufacturing
Introduction
GMP Manufacturing
GMP Inspection
Manufacture of Small Molecule APIs
Manufacture of Large Molecule APIs
Finished Dosage Forms

CHAPTER 11
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

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