PK Assays for Biotherapeutics - Part 2

Future Medicine Ltd, March 2011, Pages: 133

This is Part 2 of two Special Focus Issues of the peer-reviewed journal Bioanalysis, guest edited by Dr Eric Ezan (CEA, France) focus on the analysis of biotherapeutics. In these two special issues the aim was to gather state-of-the-art considerations on the bioanalysis of biotherapeutics in order to help bioanalysts to consider the advantages and limitations of available techniques. Both academic and industrial scientists present their point of view and expertise in this field and will hopefully lead to new analytical developments and provide a basis for harmonization of regulatory agencies.

EDITORIAL
- Specificity of bioanalytical methods for pharmacokinetic support of biological macromolecular therapeutics is important
John WA Findlay

- Ligand-binding assays: old challenges, new solutions
Philip Oldfield

NEWS & ANALYSIS
- News & Analysis

- Symposium Report: The Waters Bioanalysis World Tour: The Broadening Impact and Future of the DMPK Laboratory – Addressing Large-Molecule Therapeutics
Ryan De Vooght-Johnson

- 2011 Bioanalysis Young Investigator Award
Howard Hill, Ryan De Vooght-Johnson

- Young Investigator: Michelle J Yoo
Michelle J Yoo

REGULATORY FOCUS

- Regulatory considerations for development of bioanalytical assays for biotechnology products
Patrick G Swann, Marjorie A Shapiro

RESEARCH ARTICLE
- Comparison of an antibody capture and a cell capture ligand-binding assay to quantify a monoclonal therapeutic in serum
Franklin Spriggs, et al

PERSPECTIVE
- Bioanalytical considerations in the comparability assessment of biotherapeutics
Jean W Lee, et al

REVIEW
- Biotherapeutic bioanalysis: a multi-indication case study review
Heather A Myler, et al

- Peptide and protein drug analysis by MS: challenges and opportunities for the discovery environment
J Larry Campbell, JC Yves Le Blanc

- PK–PD modeling of protein drugs: implications in assay development
Lorin K Roskos, et al

- Challenges in developing bioanalytical assays for characterization of antibody–drug conjugates
Jean Philippe Stephan, Katherine R Kozak, Wai Lee T Wong

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