Target drug profile

Target Product Profile and Critical Quality Attribute The target drug profile consists of prospective and dynamic summary of the characteristics of a drug that should be achieved in order to reproducibly deliver the therapeutic benefit the target product profile (TPP) sets an important number of performance parameters that will be the... 

Figure 2.6 Compound target activity distribution ( promiscuity ) for 1388 drugs profiled in BioPrint assay panel (with 50% inhibition at 10pM taken as active), shown as a histogram. The number of active compounds is shown along the y-axis and the number of targets along the x-axis (adapted from ref. [6]).

The paradigm shift from critical activities from later drug development to earlier discovery phases some years ago has effectively led to a change in lead optimization and added a new dimension of complexity, while it is envisioned that from a multidimensional, data-driven process more suitable candidates in accord with the therapeutic target product profiles may emerge for the treatment of currently unmet medical needs. 

For many molecularly targeted drugs, however, the appropriate assay for selecting patients is not known and development of a classifier based on comparing expression profiles for phase II responders versus phase II non-responders may be the best approach. In such instances, one may not have sufficient confidence in the genomic classifier developed in phase II to use it for excluding patients in phase III trials as in Fig. 1. It may be better in this case to accept all conventionally eligible patients, and use the classifier in the pre-defined analysis plan. 

It is the target of research and development to elaborate a strategy, which reaches the approval of an innovative therapeutic principle. It is the responsibility of investigators to contribute in early stages of development to the definition of a target therapeutic profile of a new drug. 

PDA/PhRMA. Target product profile (TPP) A white paper on the role and utility of a target product profile in the clinical drug development process. June 15, 2004. Internet at http //www.diahome.org/content/ community/TPP White Paper.doc.)... 

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