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01 Oct 2013

Bioanalysis for Service Users

Bioanalysis for Service Users

Published October 2013
Part of the Analytical Chemistry eBook Collection
Read online
Purchase eBook

Filed Under: Anchem Collection, Bioanalysis Collection, eBook, Future Science, Medicinal Chemistry

Key Information

Price: £155

EISBN: 978-1-909453-76-0

Edited by Anne-Francoise Aubry & Jim X Shen

Overview

This book provides an important reference resource for users of bioanalytical services and will be helpful to nonexperts who need to interpret bioanalytical data or outsource bioanalytical assays. The eight chapters address many of the difficult issues and challenges in bioanalysis together with the capabilities, applications, advantages and limitations of the main technological platforms utilized. Validation principles and the experimental approaches used to establish validation parameters are explained, as well as the regulatory expectations regarding assay performance during routine sample analysis. Some guidance regarding outsourcing of bioanalytical assays and common assay performance issues and pitfalls is provided to help readers interact more knowledgeably with bioanalytical scientists and better follow investigations in the bioanalytical laboratory.

Chapters

  1. Bioanalysis and where does it fit into the drug development process?
    Anne-Françoise Aubry & Jim X Shen
  2. Perspectives of bioanalysis in drug development
    Yan G Ni, Johanna R Mora & Lora L Hamuro
  3. Practical decision-making for selection of bioanalytical CROs
    Patrick Bennett & Barbara Duncan
  4. LC techniques for bioanalysis: recent trends and developments
    Efthimia Papastavros, Cong Bi, Erika L Pfaunmiller & David S Hage
  5. Immunoassay bioanalysis for nonbioanalysts
    James Lawrence, Howard Hill & Graeme Smith
  6. LC–MS/MS bioanalysis for nonbioanalysts
    Graeme Smith & Howard Hill
  7. Practical considerations for outsourcing ligand-binding assays in a regulated environment
    Andreea Halford, Yi Qun Xiao, Roger Hayes & Marian Kelley
  8. A thoughtful scientific discourse on guidelines and method validations
    Leif D Svensson

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