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Drug Development Process and Regulatory Science

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Antibiotic Pharmacodynamics

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

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Abstract

The pursuit of antimicrobial drug development has been met with reluctance by many large pharmaceutical companies. In part, this has been due to the enormous resources required to meet regulatory standards, the risk of failure, and the current perception of regulatory uncertainty. This comes at a time when rates of antimicrobial resistance are on the rise across the globe, and there is a critical need for antimicrobial therapy. In this review, emphasis has been placed on the regulatory incentives to enhance antimicrobial drug development, and the value of pharmacokinetics-pharmacodynamics (PK-PD) principles from early development of an antimicrobial agent through late stage and post-approval/life cycle management strategies in accordance with recent guidelines. This demonstrates the potential to not only streamline the development process, driving down costs and time, but also improve the likelihood of regulatory success, making antibiotic drug development more viable and these needed agents available to the therapeutic armamentarium.

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Author information

Authors and Affiliations

  1. e2g Biopharmaceutical Consulting, 2785 Carillon Crossing, Marietta, GA, USA

    Evelyn J. Ellis-Grosse

  2. University of Maryland, Baltimore, MA, USA

    Jogarao Gobburu

Authors
  1. Evelyn J. Ellis-Grosse
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  2. Jogarao Gobburu
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Corresponding author

Correspondence to Evelyn J. Ellis-Grosse .

Editor information

Editors and Affiliations

  1. College of Pharmacolgy,Univ of Minnesota, Dept of Experimental and Clinical Pharma, Minneapolis, Minnesota, USA

    John C. Rotschafer

  2. Division of Infectious Diseases, University of Wisconsin, Madison, Wisconsin, USA

    David R. Andes

  3. College of Pharmacy and Medicine, University of Illinois, Chicago, Illinois, USA

    Keith A. Rodvold

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© 2016 Springer Science+Business Media New York

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Ellis-Grosse, E.J., Gobburu, J. (2016). Drug Development Process and Regulatory Science. In: Rotschafer, J., Andes, D., Rodvold, K. (eds) Antibiotic Pharmacodynamics. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-3323-5_24

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  • DOI: https://doi.org/10.1007/978-1-4939-3323-5_24

  • Published:

  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-3321-1

  • Online ISBN: 978-1-4939-3323-5

  • eBook Packages: Springer Protocols

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