Rationale for the Effective Use of Pharmacokinetics and Pharmacodynamics in Early Drug Development
Premarketing development of new drugs is time-consuming, costly, and does not always lead to optimal dosages. DiMasi and coworkers (1991) estimate that the mean development time of new drugs approved during the mid-80’s was 11.8 years and the average direct cost was 117 million dollars. Despite such lengthy and costly premarketing research efforts, as of April 1991, 8.3% of 192 new drugs approved during the 1980’s had undergone significant dosage changes in the approved drug labels (examples: midazolam, zidovudine, buprenorphine, alprazolam). These dosage changes were prompted by a recognition that modifications in recommended doses or dosing intervals would lead to even more efficacious or safer therapy in individual patients. Thus, if efficiency in premarketing drug development is measured by its duration, cost and optimality of dosages, it appears that the process is often inefficient.
KeywordsDosage Regimen Drug Development Drug Development Program Early Drug Development Average Direct Cost
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