The Process of New Drug Discovery and Development, Second Edition presents a practical methodology and up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. This new addition updates the scientific advances in new drug discovery and development for areas such as combinatorial chemistry, screening technologies, metabonomics, biotechnology approaches and preclinical testing. It also greatly expands the focus on the business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development, such as the financial aspects of starting up a pharmaceutical enterprise, the regulatory process, liability and litigation, and patent law.
General Overview. Integrated Product Development: From Lead Candidate Selection to Life-Cycle Management. Scientific Discoveries Application in New Drug Development. Combinatorial Chemistry. High-Throughput Screening: Enabling and Influencing the Process of Drug Discovery. Pharmacological and Pharmaceutical Profiling: New Trends. Cell-Based Analysis of Drug Response Using Moving Optical Gradient Fields. Patient-Derived Primary Cells in High-Throughput Differential Anti-Tumor Screens: Let the Patients Be the Guide. The Evolving Role of the Caco-2 Cell Model to Estimate Intestinal Absorption Potential and Elucidate Transport Mechanisms. The Promise of Metabonomics in Drug Discovery. Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA-PWG-PhRMA-DruSafe Workshop. Drugs from Molecular Targets for CNS and Neurodegenerative Diseases. Safety Pharmacology. Nonclinical Drug Safety Assessment. Preclinical Genotoxicity Testing-Past, Present and Future. Standard Drug Developmental Issues: Updated. The Need for Animals in Biomedical Research. Defining the Actual Research Approach to the New Drug Substance. Pharmaceutics and Compounding Issues in New Drug Development and Marketing. Late Stage and Process Development Activities. Clinical Development. Contract Research Organizations: Role and Function in New Drug Development. The Front Lines of Clinical Research: The Industry. Horizons for Cancer Chemotherapy (and non-Chemotherapy). Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) Clinical Testing Challenges. Regulatory and Legal Issues Affecting Drug Development. CTD: The Changing Face of the NDA. Electronic Publishing. The Important Role of Pharmacists in a Complex Risk Management System: Managing the Risks from Medical Product Use by Focusing on Patient Education, Monitoring, and Adverse Event Reporting. Liability, Litigation, and Lessons in New Drug Development. Problems in the Non-Drug Marketplace. Patents and New Product Development in the Pharmaceutical and Biotechnology Industries. The Pharmaceutical Revolution: Drug Discovery and Development. Case Histories. The Discovery of Rituxan. Funding the Birth of a Drug: Lessons from the "Sell" Side. Innovations for the Drug Development Pathway: What Is Needed Now.