Drug development projections

The NDA Pipeline. The NDA Pipeline s database [94] of more than 7000 drug development projects is available as a web-delivered, searchable information service that is updated each week. A copy of the annual book, an information service from FDC... 

The study by Prentis et al. [4] included an analysis of 198 NCEs, developed between 1964 and 1985 by British pharmaceutical companies but had not been marketed for reasons presented in Figure 1.1. Kennedy [5] further analyzed these data and noticed that a high number of anti-infective drug development projects were all terminated... 

This chapter focuses on the clinical development of new medicines. This is an area where companies can plan and control much more of their activity. As more drug development projects... 

Gordon Rewcastle obtained his PhD in Organic Chemistry from the University of Auckland in 1978, and after post-doctoral study in the U.S., he joined the Auckland Cancer Society s Research Laboratory as a medicinal chemist in 1980. Since then has participated in a number of antibacterial and anticancer drug development projects, and is the author or co-author of over 100 scientific papers and patents in the anticancer area. In all, he has made significant contributions to the development of six of the eight anticancer drugs to have gone to clinical trial from the Auckland Cancer Centre. 

Seewoester, T. (1999). The fed batch A simple but efficient approach to accelerate drug development projects. Proc. Waterside Monoclonal Conf., Norfolk, VA. 

One of the final responsibilities of the preclinical drug development project team is to prepare an IND and to submit the appropriate documents to the FDA or other regulatory agency. As the development of the drug candidate moves into the clinic, the preclinical project team becomes a clinical project team. 

TABLE 27.4 Discounted Cash Flows for a Hypothetical Drug Development Project ... 

While a drug development team may have only one primary physician, it may have multiple scientists. Pharmacokineticists, pharmacologists, toxicologists, and pharmaceutical scientists are all involved in the clinical development of drugs. The contributions of scientists to a drug development project are derived from their experience in both scientific methodology and basic research. ... 

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