Regulatory affairs
Chapter 20 Regulatory affairs I. Hägglöf, Å Holmgren Introduction This chapter introduces the reader to the role of the regulatory affairs (RA) department of a pharmaceutical company, outlining the process…
Chapter 20 Regulatory affairs I. Hägglöf, Å Holmgren Introduction This chapter introduces the reader to the role of the regulatory affairs (RA) department of a pharmaceutical company, outlining the process…
Chapter 10 Metabolism and pharmacokinetic optimization strategies in drug discovery P. Ballard, P. Brassil, K H. Bui, H. Dolgos, C. Petersson, A. Tunek, P J H. Webborn Introduction Optimization of…
Chapter 22 Drug discovery and development facts and figures H P. Rang, R G. Hill In this chapter we present summary information about the costs, timelines and success rates of…
Chapter 8 High-throughput screening D. Cronk Introduction: a historical and future perspective Systematic drug research began about 100 years ago, when chemistry had reached a degree of maturity that allowed…
Chapter 12 Biopharmaceuticals H. LeVine Introduction The term ‘biopharmaceutical’ was originally coined to define therapeutic proteins produced by genetic engineering, rather than by extraction from normal biological sources. Its meaning…
Chapter 7 The role of information, bioinformatics and genomics B. Robson, R. McBurney The pharmaceutical industry as an information industry As outlined in earlier chapters, making drugs that can affect…
Chapter 21 The role of pharmaceutical marketing V M. Lawton Introduction This chapter puts pharmaceutical marketing into the context of the complete life-cycle of a medicine. It describes the old…
Chapter 14 Drug development Introduction H P. Rang, R G. Hill Introduction Drug development comprises all the activities involved in transforming a compound from drug candidate (the end-product of the…
Chapter 17 Clinical development present and future C. Keywood Introduction Clinical development is the art of turning science into medicine. It is the point at which all the data from…
Chapter 9 The role of medicinal chemistry in the drug discovery process P. Beswick, A. Naylor Introduction Clinically the unmet need for novel and safe drugs is becoming more significant…