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Development of Antibody-Based Therapeutics pp 207–222Cite as

Application of PK-PD Modeling and Simulation Approaches for Immuno-Oncology Drugs

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Abstract

The recent breakthroughs in immunotherapy have made a significant impact on treating a wide range of cancer indications; however, this success has brought about new challenges with critical relevance to the design of optimal dose and dosing regimens both as single-agent therapy and in combination with other cancer drugs. Since the first immune checkpoint inhibitor (ipilimumab) was introduced in clinical practice in 2011, there has been considerable interest in evaluation of the key regulatory mechanisms involved in activation of the immune system while identifying sources of variability in the clinical response to such therapies. Hence, it is evident that application of quantitative approaches can highly enhance knowledge regarding the underlying variables important for designing effective dosing strategies in I-O therapies. This chapter focuses on the application and potential impact of PK-PD modeling on I-O therapy.

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Authors and Affiliations

  1. Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Princeton, NJ, USA

    Xiaochen Zhao, Xiaoning Wang, Yan Feng & Shruti Agrawal

  2. Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY, USA

    Dhaval K. Shah

Authors
  1. Xiaochen Zhao
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  2. Xiaoning Wang
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  3. Yan Feng
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  4. Shruti Agrawal
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  5. Dhaval K. Shah
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Corresponding authors

Correspondence to Shruti Agrawal or Dhaval K. Shah .

Editor information

Editors and Affiliations

  1. Merck & Co., Inc., Palo Alto, CA, USA

    Mohammad A. Tabrizi

  2. Biologics Discovery, TESARO, Waltham, MA, USA

    Gadi G. Bornstein

  3. SKD Consulting LLC, Broomfield, CO, USA

    Scott L. Klakamp

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Zhao, X., Wang, X., Feng, Y., Agrawal, S., Shah, D.K. (2018). Application of PK-PD Modeling and Simulation Approaches for Immuno-Oncology Drugs. In: Tabrizi, M., Bornstein, G., Klakamp, S. (eds) Development of Antibody-Based Therapeutics. Adis, Singapore. https://doi.org/10.1007/978-981-13-0496-5_11

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  • DOI: https://doi.org/10.1007/978-981-13-0496-5_11

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  • Publisher Name: Adis, Singapore

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  • Online ISBN: 978-981-13-0496-5

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