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Drug Development Perspectives: |
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Nuggehally R. Srinivas |
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$99.75 |
July 2010 |
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Illustrated: |
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Preface
Drug
development has evolved over time, factoring in the various requirements of
clinical pharmacology, biopharmaceutics, drug metabolism, pharmacokinetics
(PK), pharmacodynamics, etc to ensure safety and efficacy of the novel
chemical/molecular entity (NCE/NME) being developed.
While it is recognized that each NCE/NME poses distinct challenges in one or
more areas of drug development, the lessons learned from a drug development
cycle can contribute immensely to our overall understanding of drug
development. Such key learnings may help in formulating pragmatic/practical
approaches in solving some commonly occurring developmental issues.
However, there are numerous situations where outside-the-box approaches may
have to be applied creatively for answering scientific questions or solving
developability issues. In present-day drug development, alignment of functional
expertise is important for understanding, strategizing, and operationalizing
drug development initiatives. In order to better appreciate the complexities
and intricacies of drug development, select topics that cater to the different
functions involved in the drug development processes are presented as unique
chapters. The topics are varied, and the carefully chosen case studies provide
insight into significant issues in today's drug development paradigm.
The book seeks to provide thought-provoking discussion and perspectives on drug
development with carefully chosen topics in bioanalysis, allometry, CYP
metabolism, PK simulations, combinations of diverse clinical pharmacology, and
PK considerations, with emphasis on genetic polymorphism. It is intended for a
wide range of scientists in late drug discovery, preclinical, and clinical
stages of NCE/NME development in the pharmaceutical/biotech industry and for
university researchers and academics.