Fundamentals of Early Clinical Drug Development covers both recent advances in the design and synthesis of new drugs, as well as the numerous other issues facing a new drug candidate as it moves through the development process.

Utilizing recent case studies, Fundamentals of Early Clinical Drug Development provides valuable insights into the complexities of the process, from designing new synthetic methodologies and applying new automated techniques for finding optimal reaction conditions to selecting the final drug form and formulation.

Contents

1. Reflections on Process Research
2. Development and Scale-Up of a Heterocyclic Cross-Coupling for the Synthesis of 5-[2-(3-Methyl-3H-imidazol-4-yl)-thieno[3,2-b]pyridine-7-yl] amino-2-methyl-1H-indole
3. Large-Scale Enantioselective Preparation of 2E,7E 5S,6R,5-Hydroxy-6-methyl-8-phenyl-octa-2,7-dienoic Acid, a Key Fragment for the Formal Total Synthesis of the Anti-tumor Agent Cryptophycin
4. Efforts Toward a Commercially Viable Route and Process to the Synthesis of HIV PI GW640385X
5. Development of an Asymmetric Synthesis of ABT-100
6. Asymmetric Hydrogenation: A New Route to Pregabalin
7. Responsibilities of the Process Chemist: Beyond Synthetic Organic Chemistry
8. Outsourcing—The Challenge of Science, Speed, and Quality
9. Automation and the Changing Face of Process Research in the Pharmaceutical Industry
10. Large-Scale Synthesis: An Engineering Perspective
11. Synthesis and Application of Radioisotopes in Pharmaceutical Research and Development
12. Selection of the Drug Form in Exploratory Development
13. Strategies to Achieve Particle Size of Active Pharmaceutical Ingredients
14. Challenges in Early Formulation: Turning Drug Substance into Drug Product
15. Intellectual Property and Early Development

Index

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