Therapeutic team development

Chemical Development s primary objective is to provide quality active pharmaceutical ingredients (APIs) for company Therapeutic Team programs, on time... 

From the outset our mission, enhanced by manufacturing responsibilities, required that our organizational structure should not be solely that of a service department for the Therapeutic Teams, and Discovery and Development departments, even though this was our primary mission. 

All the protein-based potential therapeutics discussed above fail to meet any of these criteria. Low molecular mass antagonists of IL-5 or its receptor may prove of most use. A number of research teams are screening for such substances. The development strategies pursued include ... 

This chapter discusses the various types of project teams that are involved in the drug discovery and development process. It also provides a detailed example of a drug development logic plan for what many developmental pharmaceutical scientists consider to be the most difficult and time- and resource-consuming drug candidate to develop into a therapeutic product. 

The final responsibility of the clinical project team is to ensure that all the research studies are appropriately documented in technical reports or scientific publications, and to compile this information, along with the necessary summaries, into an NDA or BLA submission. After submission, the project team interacts with the regulatory agency and provides answers to any questions. If requested, the project team designs and conducts the necessary research studies to support the submission. Once the NDA or BLA has been approved, the final responsibility of the clinical development team is to coordinate the launch of the new therapeutic agent. 

The focus of the Business Development and Support Team is to develop policy, strategic direction and business opportunities for Medsafe, as well as to facilitate the output of the Evaluation and Compliance Tecims. The team also has a pharma-covigilance function in relation to the monitoring of adverse reactions and is involved in providing information and advice to health professionals and consumers on the safe and effective use of therapeutic products. 

The pharmacist s role on the drug development team has greatly expanded the professional opportunities of individuals with backgrounds in pharmacy. Pharmacists can provide valuable therapeutic insight into medical research. Training of pharmacists as clinical scientists with... 

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