Guide to Drug Development: A Comprehensive Review and Assessment

Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, "Guide to Drug Development" is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards. Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. Spilker's "Guide to Drug Development" will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.

Table of Contents:
SECTION 1 Introduction and Overview of a Company and the Industry Introduction to Drug Development Pharmaceutical Industry: Definitions The Big Picture Standards: Types, Uses, and Issues Pharma-think, Academic-think, and Government-think Pharma Sense versus Common Sense Section 2 Basic Principles, Strategies, and Approaches Overview of Factors Affecting Drug Discovery The Drug Discovery Process Golden Rules of Drug Discovery The Drug Development Process Golden Rules of Drug Development Biotechnology Extrapolating Animal Safety and Efficacy Data to Humans Evaluating and Interpreting Data Stimulating Innovation and Increasing Efficiency with the Right Questions, People, Milieu, and Approaches A New Paradigm of Drug Development Future Environments for Drug Discovery and Development Section 3 Corporate Organization and Management Issues Models of International Operations Organization at the Corporate Level Corporate Management Reducing Pharmaceutical Risk Enhancing Communication Personnel and Staffing Issues Competitive Intelligence Conflicts of Interest and Bias Crisis Management Mergers, Joint Ventures, and Alliances Pharmacopolitics Institutional Memory Differences among Pharmaceutical Companies Section 4 External Corporate Relationships and Interactions Interactions and Relationships between Academicians and Industry Investigator-sponsored Research Proposals Submitted to Industry Technology Transfer from Academia to Industry Interactions between Pharmaceutical Companies Interactions with Trade Associations Interactions with Legislators and Government Agencies Interactions and Relationships with Healthcare Professionals Interactions with Patients and the Public Patient Package Inserts Interactions and Relationships with the Media Section 5 Research and Development Organization, Management, and Assessments Organizing Research and Development Managing Research and Development and Avoiding Tangents Personnel Issues in Drug Discovery and Development Myths about the Pharmaceutical Industry and Drug Development Fads and Fashions in Drug Development The Many Facets of Reality: Approaches to Issues and Problems International Organization and Management Project Management: Balancing Line Function and Matrix Approaches Choosing the Number and Types of Drugs to Develop Choosing Standards for Developing Drugs Creating and Using Benchmarks Evaluating a Portfolio of Investigational Drug Projects Compassionate Use Programs Virtual Drug Development Developing and Marketing Orphan Drugs for Rare Diseases Productivity and Project Success Overview of Safety and Risk Management Developing Standard Operating Procedures Section 6 Clinical Activities and Issues Introduction to Clinical Trials Creating a Clinical Strategy and Development Plan for a New Drug or Indication Designing and Implementing a Clinical Trial Questions to Ask about a Clinical Trial Protocol Dose-esponse Relationships in Clinical Trials Collecting and Interpreting Life Events Data in Clinical Trials Quality of Life and Pharmacoeconomics in Clinical Trials Overview of Phase 4 and Postapproval Clinical Activities Phase 4 Trials and Postapproval Pharmacovigilance Methodologies Feasibility of Multinational Trials Groups that Influence Protocol Design Monitoring and Auditing a Clinical Trial