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new drug development
#1



Christopher P. Adams & Van V. Brantner
Bureau of Economics
Federal Trade Commission


Abstract
This paper analyses a detailed data set on drugs in human clinical trials around the world between 1989 and2002. The data provides information on the probabilities with which drugs successfully complete thedifferent phases of the trials and the durations of successful completions. The paper shows that successrates and durations can vary substantially across observable characteristics of the drugs, including primaryindication, originating company, route of administration and chemistry. It suggests that analysis of this typeof data can help us to answer questions such as: Do AIDS drugs get to market faster? Do Biotech drugshave higher probabilities of getting to market? This paper provides some general statistics for analyzing thesequestions.

Introduction
The dynamics of drug development is one of the defining characteristics of the pharmaceutical industry. Despite its importance to the industry, there is little information on how long it takes for particular drugs togo through human clinical trials and the probabilities of successful completion. Recently, a number of authorshave started making use of historical data on the development of drugs through human clinical trials in theUS and elsewhere in the world (for example, Abrantes-Metz, 2003, Kyle, 2002, Danzon et al, 2003). These authors are using this data examine determine the relationship between drug characteristics andsuccessful durations, market entry, and the use of licensing arrangements, respectively. This type ofhistorical data has the potential to provide industry analysts with a much clearer picture of late stagepharmaceutical development and new drug entry. The current paper presents some summary statistics onduration and frequencies of successful completion of the human clinical trials. While this analysis is notsophisticated or detailed enough to provide answers to many of the questions researchers and practitionersare interested in, it does provided readers with some stylized facts to guide future work.The paper analyzes a sample of drugs that have entered human clinical trials somewhere in the worldbetween 1989 and 2002. The data provides information on entry and exit dates from the three differentstages of the human clinical trials for the first indication that the drug was being developed (post-1989). Thedata also provides information on drug characteristics such as primary indication, chemical composition,route of administration and originating company. The analysis provides frequencies with which drugs withdifferent characteristics successfully complete the different stages of the human clinical trials. For example,drugs that have been originally developed by one of the 10 largest drug companies have a higher thanaverage probability of getting to market. The analysis also provides mean durations for drugs thatsuccessfully complete the different stages of the human clinical trials. For example, AIDS drugs are inhuman clinical trials for an average of 5 years, which is 3 years shorter than the average drug in the sample. In general, the results presented should not be interpreted as causal effects of drug characteristics onsuccess rates or successful durations. Rather these results should be interpreted as central tendencies orsimply as statistical observations of the drug development process.

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#2

my name is vishnu iwant a detail description about new drug develpoment to give a seminar in the college and i also want a detail notes on parentral drug delivery system
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