Titlebook: Biopharmaceutical Drug Design and Development; Susanna Wu-Pong (Director),Yon Rojanasakul (Profes Book 2008Latest edition Humana Press 200

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Pharmacogenetics in the Clinic,s may account for as much as 30% of interindividual differences in drug disposition and response. An increasing number of drug target polymorphisms have also been linked to differences in drug response. This chapter reviews some examples of the use of pharmacogenetics in clinical practice. Despite t

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Molecular Modeling: Considerations for the Design of Pharmaceuticals and Biopharmaceuticals,r-assisted drug design (CADD) and at the same time present context with respect to the discovery, design, and development of therapeutic agents. Note is also made to some of the challenges that lie at the cutting edge of these disciplines. We highlight a number of techniques and related software pro

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Changes in Biologic Drug Approval at FDA,promote rationale drug development. The agency is dynamic, and whereas plans are in place that may provide some concept of the direction of future changes for both drug and biologics reviews, local and world events often cause a reactionary response at the FDA that is often unpredictable. What is cl

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Follow-On Protein Products: The Age of Biogenerics?, no FOPP have yet been approved in the US or European pharmaceutical market. This is because of a lack of registration process for the demonstration of pharmaceutical and therapeutic/clinical equivalence. The production of FOPP is a significant opportunity for patients, managed health care providers

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Pharmacogenetic Issues in Biopharmaceutical Drug Development,e. By their very nature, many of the diseases in question are multigenic and do not lend themselves to simple pharmacogenetic analysis. Some key examples of these and other issues surrounding the use of genetic information to combat human diseases are presented.