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1 5 years Regulatory Approval 5 10 years Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials 1 5 years
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FIGURE 1.3 The modern drug development process as practiced in the United
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States. Figures in parentheses are the number of candidate drugs, indicating the high fail ure rate of the process.
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multinational pharmaceutical rm to begin production. Not only would the rm be liable for adverse drug reactions, but there are multiple inter national, national, and local licensing requirements that must be met, as described by the drug development process. A central component of the drug discovery process is target or candi date drug discovery. Once a target is identi ed, there is an involved screen ing process, followed by lead development, and then preclinical trials. Screening and lead development identify candidate drugs that have a de sired effect in vitro that is, in the laboratory using test tubes. Candidate drugs that exhibit the desired effects in the laboratory are then used in pre clinical trials on mice, rabbits, or other live subjects. The objective of screening, lead development, and preclinical trials is to demonstrate the bioactivity and safety of the candidate drug. With data from these preclini cal trials, typically using mice and other lab animals, a proposal for clinical trials on humans is made to the Federal Drug Administration (FDA). Drugs with poor results in preclinical trials take longer to get ap
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proved. Regulatory approval can take a year, or take as long as ve or more years. Furthermore, there is no guarantee that a candidate drug will be allowed to enter clinical trials. Of 5,000 candidate drugs identi ed in the drug discovery process, only about ve or 0.1 percent receive regu latory approval for clinical trials. Clinical trials are conducted in three phases, using an increasing num ber of subjects with each phase. The goal in Phase I, which may extend a year or more, is to quantifying safety and dosage information in a few dozen healthy volunteers. The focus of Phase II, which involves several hundred patients over the course of one or two years, is to document effec tiveness and side effects. Phase III, the most comprehensive and largest phase of clinical trials, is concerned with documenting the adverse reac tions as well as the effectiveness of the candidate drug on up to several thousand patients over a period of two or three years. Given the time and number of patients involved, Phase III Clinical Trials typically account for 75 percent or more of a $200 to 800 million drug development budget. Once clinical trials have demonstrated the safety, ef cacy, and clinical value of a drug, application for approval to market the candidate drug for a speci c purpose is made to the FDA. This regulatory approval process typically lasts several years, depending on the strength of the clinical trial results. Extenuating circumstances, such as a drug that has the potential to cure a previously untreatable, deadly disease, such as AIDS, may be fasttracked through the approval process to market, but this is the exception. As illustrated in Figure 1.4, even without fast tracking, the approval times have diminished signi cantly since their highs in the late 1980s. The aver age approval time for 23 new drugs was approximately 33 months in 1989, compared to nearly 13 months a decade later for 35 drugs. Changes at the administrative level of the FDA in 2002 promise to result in a short ened approval cycle. During the nal regulatory approval process, the pharmaceutical com pany typically spends tens of millions of dollars preparing marketing mate rials, from clinical symposia, to advertisements on the Web and in print, to continuing medical education (CME) dinner meetings for clinicians. If the nal FDA review process ends in approval, then the drug is re leased to the marketplace. However, the responsibility of the pharmaceuti cal company doesn t end there. Phase IV of the clinical trials process extends for as long as the drug is on the market, especially while the drug is protected by patents and is unavailable in generic form. On occasion, a drug that has successfully navigated through the drug development process turns out to cause serious side effects when released to tens or hundreds of thousands of consumers. A recall in Phase IV of clinical trials is extremely costly to the pharmaceutical company. Not only may there be patient litigation to deal with, but the monies invested in marketing and
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