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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Laws and Regulations: The Discipline of Regulatory Affairs,ies and competitive landscape, protection of the intellectual property surrounding a drug product, and the compliance efforts of a pharmaceutical company. It requires knowledge and, most importantly, interpretation of the most current requirements of regulatory authorities around the world.

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Formulation and Manufacturing,y result in a patient taking a tablet, inhaling a powder, or taking some other formulation of a drug product to alleviate or cure a malady. This chapter focuses on the steps entailed to create the actual product, the formulation, which a patient takes for his or her malady, from initial concept thro

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