Drug development milestones

Milestone charts consist of a tabulation of major drug development milestones. Whereas the Go/No-Go decisions discussed previously are very project specific development milestones are much more generic and can usually be applied to a wide variety of projects. Typical milestones for pharmaceutical development are shown in Table 27.10. 

As every NCE brought forward into development is unique, the exact role that reference standards take for a specific drug candidate will vary but is generally keyed to drug development milestones. At any phase of drug development, the reference standard should be assessed versus its... 

QT liability during drug development are important milestones but leave many questions unanswered for example, do false nondinical negatives with a significant clinical torsadogenic risk exist Are there reliable markers of the true torsadogenic potential of a new drug ... 

There are several natural milestones during drug development, and although there are differences between companies, both in the number and in the names of the milestones, these differences are quite small. The first milestone is the selection of a compound in the drug discovery phase for development. In the past this decision was exclusively based on the pharmacology (potency, selectivity) of the compound. Since there is now greater awareness that compounds with attractive pharmacological properties may fail later because of poor solubility or extensive metabolism, the physical chemistry, preliminary PK and metabolism characteristics of the... 

Figure 3.1 Hypothetical drug development pipeline, illustrating activities during a 12-month period. Three stages of drug development are indicated at the bottom of the figure. The corresponding milestones for each stage are indicated at the top of the figure. (Courtesy of Milestone Development Services, Newtown, Pa., USA.)...

One strategy is to update the report as each milestone in the drug development process is achieved. 

Seen from the perspective of recent events, the clinical development of protease inhibitors follows rather conventional programs for drug development. The most remarkable characteristic of the clinical development of HIV-1 protease inhibitors is their rapid clinical evaluation, regulatory approval, and subsequent incorporation into standard treatment regimens. Undoubtedly, the pressure to develop new and active compounds to treat persons with HTV infection contributed to the urgency of drug development. This section will review the clinical milestones for HIV-1 protease inhibitors and discuss some of the near future clinical directions for these compounds. Peer-reviewed, published manuscripts are the basis for this review. Data presented at meetings and published in abstracts were not used. 

Preparing a detailed drug development plan, including designation of key points or development milestones, generating a timeline for completion, and defining the critical path... 

FIGURE 2.3 An overview of the drug development process that illustrates the activities within the four major stages of drug development drug discovery, preclinical development, clinical development, and manufacturing. (Courtesy of Milestone Development Services, Newtown, PA, 1998. With permission.)... 

Tufts Center for the Study of Drug Development. 2001. Research milestone. Boston Tufts Center for the Study of Drug Development. 

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