Toxicological Support For Phase Iiiii Studies

Non-clinical toxicology studies required to support Phase II and Phase III stages of the program depend upon a variety of factors. First, as shown in Tables 6.1 and 6.2, the ultimate clinical regimen, i.e. duration of therapy or treatment, determines the ultimate duration of the animal studies. For example, a diagnostic agent or a drug with a 3- 4 day regimen [as might be the cases for disease or trauma situation that are handled in the intensive care unit may require little in the way of additional repeated-dose toxicity studies. In comparison, a new antihypertensive agent may require all of the longer-term studies.

Second, the drug development strategy established by the company may call for the availability of proof of absorption and perhaps even preliminary proof of efficacy (sometimes called 'proof of principle') before expending resources for the longer and more expensive studies. On the other hand, the company may have determined that the drug in question is on a 'fast track', and is willing to expend resources early in the hopes of getting an earlier approval, and thus to the market faster. The following sections will summarize the areas that need to be addressed.

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