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structural activity studies focused on one or more biological activities. It also makes good sense to optimize development candidate selection by examining other preclinical data which will be critical for development. In each of the nonclinical development disciplines (chemistry, pharmaceutics, drug metabolism, pharmacokinetics and toxicology) key pieces of data may be obtainable at modest cost and to aid in selecting the best development candidate. Basic stability and solubility studies of a drug substance, at an early stage may reveal the need to select a better salt or an alternative candidate. Characterizing the basic pharmacokinetics may highlight a best option candidate. In vitro genotoxicity testing should certainly be undertaken early. Although additional resources are required to more fully profile a limited selection of development lead candidates, the payback in improved input quality to development will more than justify the effort. |
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2.
The Product ProfileA Strategic Tool for Drug Development. |
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The key strategic tool which guides drug development is the Target Product Profile (TPP). The TPP describes the specifications of the product intended to be introduced into the market [1]. It defines the required efficacy and side effect profile of the product, how it is supplied, how it is to be used, in which patient groups, and for what purpose. It specifies the cost of goods and the time of market introduction. It is the key design template for creating the development plan. It defines the performance requirements which enables the commercial organization to assess the market impact and estimate the commercial return. Teams sometimes confuse what they hope to see in the performance of a development compound with the minimum performance that would provide for a viable commercial opportunity. It is essential to define a minimum TPP specifying the minimum performance for commercial viability. The expected product performance can also be defined alongside the minimum TPP, and commercial forecasts can be provided for both. The specific attributes within the TPP constitute a package. If a change is made in one attribute, the whole TPP must be reviewed again to ensure that the impact of the change is fully understood. The TPP has to be set in a specific time frame for launch because any change in schedule may result in an important change in the market environment, e.g., competitor launch. |
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The TPP is dynamically affected by internal and external factors. Internal factors can include clinical and nonclinical development findings. External factors include, for example, new competitor clinical results just released. Therefore, the TPP is generally reset in development. The TPP is a contract between R&D and the commercial organization (Fig. 1). The |
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