Drug Development Perspectives:
Considerations, Challenges, and Strategies

Nuggehally R. Srinivas

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July 2010
328 pp.

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ISBN: 978-0-9664286-9-8



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.

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