The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries' trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market.
Contents
SECTION 1
INTRODUCTION AND BACKGROUND
1. The development of the pharmaceutical industry
H P Rang
2. The nature of disease and the purpose of therapy
H P Rang, R G Hill
3. Therapeutic modalities
H P Rang, H LeVine, R G Hill
SECTION 2
DRUG DISCOVERY
4. The drug discovery process: general principles and some case histories
H P Rang, R G Hill
5. Choosing the project
H P Rang, R G Hill
6. Choosing the target
H P Rang, R G Hill
7. The role of information, bioinformatics and genomics
B Robson, R McBurney
8. High-throughput screening
D Cronk
9. The role of medicinal chemistry in the drug discovery process
P Beswick, A Naylor
10. DMPK optimization strategy in drug discovery
P G Ballard, P Brassil, K H Bui, H Dolgos, C Petersson, A Tunek, P J H Webborn
11. Pharmacology: its role in drug discovery
H P Rang
12. Biopharmaceuticals
H LeVine
13. Scaffolds: Small globular proteins as antibody substitutes
D Grabulovski, J Bertschinger
SECTION 3
DRUG DEVELOPMENT
14. Drug development: introduction
H P Rang, R G Hill
15. Assessing drug safety
H P Rang, R G Hill
16. Pharmaceutical developmentT Lundqvist, S Bredenberg
17. Clinical Development - Present and Future
C Keywood
18. Clinical imaging in drug development
P M Matthews
19. Intellectual property in drug discovery and development
P Grubb
20. Regulatory affairs
I Hägglöf, Å Holmgren
21. Marketing the drug
V L Lawton
SECTION 4
FACTS AND FIGURES
22. Drug discovery and development - facts and figures
H P Rang, R G Hill
