Drug development project team approach

The drug development team must ensure that reference standards will be available to support the launch of a newly approved product once FDA approval is obtained. The quality control function is typically separate from the analytical development function in most firms, so a high level of cooperation and communication are critical. As launch approaches, the drug development team must work closely with the commercial manufacturing quality control unit to coordinate the supply of reference standards to the firm s compound distribution system. It is useful to involve marketing forecasts to predict the approximate amounts of reference standards—based on projected batches—that will be necessary to support a worldwide launch. 

A useful model is one that serves as an effective communication tool. Often pharmacokineticists are asked by project teams in the pharmaceutical industry to interpret safety or efficacy data in relation to drug concentrations. Is there a relationship between the two A quantitative approach to the problem would be to develop a model relating drug concentrations to effect (exposure-response). The model can then be presented... 

Profile Founded in late 1996, SIDDCO is a privately held company that is based on a mission to integrate and apply state-of-the-art approaches to drug discovery. SIDDCO is a combinatorial chemistry consortium that pools the resources of the consortium partners to fund a critical mass of chemists to develop the combinatorial chemistry technology database and methodologies. SIDDCO provides a dedicated team of medicinal chemists to each partner to exploit the shared technology and satisfy the drug discovery and drug optimization needs of specific projects. 

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