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Application of Modeling and Simulation in the Development of Protein Drugs

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Clinical Trial Simulations

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 1))

Abstract

Protein drugs have a variety of molecular characteristics, functional properties, and pharmacokinetic characteristics that are uniquely different from small molecule drugs. The pharmacokinetics of protein drugs are often intricately linked to the biology of the drug target and the pharmacological properties of the drug. Mechanistic PK-PD models can be built to describe these unique drug characteristics and simulate nonclinical and clinical outcomes. PK-PD modeling and simulation can be applied from the earliest stages of drug discovery to late-stage clinical development. The application of model-based drug discovery and development can improve the probability of successful development of protein drugs.

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Authors and Affiliations

  1. Pharmacokinetics, Pharmacodynamics & Bioanalysis, Translational Sciences, MedImmune, Inc., One MedImmune Way, Gaithersburg, MD, 20878, USA

    Lorin K. Roskos

Authors
  1. Lorin K. Roskos
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  2. Song Ren
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  3. Gabriel Robbie
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Corresponding author

Correspondence to Lorin K. Roskos .

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Editors and Affiliations

  1. Department of Advanced Modeling & Simula, Janssen Research & Development, LLC, Route 202 S. 920, Raritan, 08869, New Jersey, USA

    Holly H. C. Kimko

  2. Dept. Biopharmaceutical Sciences, University of California, San Francisco, Parnassus Ave. 513, San Francisco, 94143-0446, California, USA

    Carl C. Peck

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Roskos, L.K., Ren, S., Robbie, G. (2011). Application of Modeling and Simulation in the Development of Protein Drugs. In: Kimko, H., Peck, C. (eds) Clinical Trial Simulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 1. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7415-0_17

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