Bioanalysis for Service Users

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