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Published benchmarks of development phase durations can serve as a measure to indicate whether the time lines of a plan are aggressive or comfortable. Real development times show wide variations. Some of this is caused by different study requirements for different indications or by particular experimental or technical problems with the development compound. However, some companies show consistently shorter development times than others, which is probably indicative of good project planning and management. Table 6 lists some recent benchmark data from various sources. An aggressive development plan must aim for a duration at the lower end of this list because the durations shown in Table 6, in many cases, reflect delays resulting from unexpected problems which always occur in practice. |
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Additional time-saving possibilities may be achieved by reviewing national requirements for technical and safety data or finalized vs. summary reports for clinical trial permissions and placement of studies in territories where these can be expedited. Typically, phase I may be started earlier in many European countries than in the U.S. In contrast, toxicology coverage requirements for phase II studies are less stringent in the U.S. Another interesting possibility is to use the cold season in the Southern Hemisphere for an anti-infective study instead of waiting for the next winter in the North. |
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The following sections are further practical examples of the necessary considerations and decisions for different tasks of the development process. |
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1.
Toxicology and Safety Investigations |
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Existing guidelines allow considerable flexibility in designing the toxicological program with regard to species selection, duration, and sequence of studies. The ideal species are those in which pharmacokinetics and metabolism are most similar to the human. Unfortunately, human data are |
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| | Reported Clinical Development Phase Durations for Compounds in Development for Chronic Indications During 19901992 in Months |
| | | | | | | | | | | | | | | | Phase I | | | | | | | | 11.5 | | | Phase II | | | | | | | | 24 | | | Phase III | | | | | | | | 34 | | | Source of data: Centre for Medicines Research (CMR) report CMR94-6R, The Strategy and Management of Successful Global R&D, August 1994 and CMR Poster presented at the Drug Information Association 30th Annual Meeting June 59, 1994, Washington, DC. |
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