Titlebook: Drug and Biological Development; From Molecule to Pro Ronald P. Evens Textbook 2007 Springer-Verlag US 2007 Biological.Development.Drugs.Ev

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very through a product’s life cycle.The unique features of tRonald P. Evens Editors and Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Editor . . . . . . . . . . . . . . . . . . . . . .

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R&D Outcomes,ctivity, meet the needs of the public and health care community for the best products used optimally, meet the needs of the shareholders, and sustain the company’s research edge against the competition.

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Types of Clinical Studies,nd differing requirements for patient types, goals, inclusion/exclusion criteria, design features, and expected outcomes. Combined, they build the patient care database for safety and efficacy that hopefully will lead to product approval.

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Special Considerations in Research,Cardiovascular research is addressed in this chapter as a special therapeutics area, especially given its different and unique study needs and designs, the many indications for use of the products, the extensive pharmaceutical markets in patient numbers and sales potential, and the many products that exist and are investigational agents.