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Fig. 1
Diagrammatic representation of the preclinical and clinical phases of drug
development. Note the overlap in the development phases and the need for clinical
pathology monitoring (indicated by arrows) throughout the process. |
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the clinical pathology. For clinical trials, on the other hand, traditionally all the clinical pathology is performed at local laboratories or contracted to regional or central laboratories. The advantages and disadvantages of the use of various types of laboratories for the support of clinical trials will be discussed in this chapter. We will also identify the need for establishing good relationships with external laboratories and describe the pitfalls that need to be avoided to successfully and efficiently complete the clinical pathology contribution to a clinical drug development program. |
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At Zeneca, the clinical pathology laboratory has supported Phase I clinical pharmacology trials for more than 2 decades. The test profiles can be extensive |
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