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Pharmacodynamic Evaluation: CNS Methodologies

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology

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Abstract

Drug discovery in neurology is confronted with a high attrition of compounds in both early and mid-stages of the development cycle. The causes of these failures are multiple and mainly based on the uncertainty around the precise pathological processes, lack of reliable biomarkers, and variability of drug penetration through the blood-brain barrier (BBB) into the brain. The first section of this chapter focuses on pharmacokinetic/pharmacodynamic (PK/PD) aspects when developing a medication targeting brain disorders. The biomarker section discusses those markers employed in the most common neurological disorders. It addresses their advantages and limitations, and how they serve in confirming efficacy and, in some instances, the safety of therapeutic interventions.

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Author information

Authors and Affiliations

  1. Neurology Center of Excellence, IQVIA, Reading, Berkshire, UK

    Lynne Hughes

  2. Neurology Center of Excellence, IQVIA, Paris, France

    Marie Trad

  3. Clinical Research Operations, Cavion, Charlottesville, VA, USA

    Stacey Boyer

  4. CNS-TAU, Takeda Pharmaceutical International Co., Cambridge, MA, USA

    Deborah Lee

  5. Quantitative Clinical Pharmacology, Takeda Pharmaceuticals, Cambridge, MA, USA

    Wei Yin

Authors
  1. Lynne Hughes
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  2. Marie Trad
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  3. Stacey Boyer
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  4. Deborah Lee
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  5. Wei Yin
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Corresponding author

Correspondence to Lynne Hughes .

Editor information

Editors and Affiliations

  1. CorDynamics , Dieburg, Germany

    Franz J. Hock

  2. CorDynamics , Chicago, Illinois, USA

    Michael R. Gralinski

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Hughes, L., Trad, M., Boyer, S., Lee, D., Yin, W. (2018). Pharmacodynamic Evaluation: CNS Methodologies. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_32-1

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  • DOI: https://doi.org/10.1007/978-3-319-56637-5_32-1

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  • Print ISBN: 978-3-319-56637-5

  • Online ISBN: 978-3-319-56637-5

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