1.

Record Nr.

UNINA9910580279803321

Titolo

Concepts de l’ordinaire

Pubbl/distr/stampa

Éditions de la Sorbonne

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

2.

Record Nr.

UNINA9910830679803321

Titolo

Bioanalytical aspects in biological therapeutics / / edited by Xiaohui Xu, Weifeng Xu

Pubbl/distr/stampa

Hoboken, New Jersey : , : John Wiley & Sons, Inc., , [2022]

©2022

ISBN

1-119-52324-9

1-119-52323-0

Descrizione fisica

1 online resource (394 pages)

Disciplina

615.19

Soggetti

Biological products - Therapeutic use

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Includes index.

Nota di contenuto

Overview of the development of biotherapeutics and the role of bioanalytical sciences / Robert Dodge -- Basic immunology for bioanalytical testing of biotherapeutics / Kang Chen and Weifeng Xu -- Platform and instrument considerations in bioanalytical testing / Dominic Warrino and Frank Spriggs -- Pharmacokinetic assays / Tong-Yuan Yang and Eric Wakshull  -- Recent progress in biomarker bioanalysis and target engagement assessment / Yan G. Ni, Lindsay King, and Carmen Fernández-Metzler -- Immunogenicity risk prediction and assessment for biotherapeutics / Jochem Gokemeijer -- Bioanalytical strategy to support clinical immunogenicity assessment : antidrug antibodies / Ying Wang and Michael Luong -- Bioanalytical



scheme for antidrug neutralizing antibody assays / Weifeng Xu, Bonnie Wu and Jim McNally -- Critical reagents in bioanalysis / Yang Xu, Agostinho Gomes Rocha, Shannon Chilewski, Krisna C. Duong-Ly, Kun Yang and Jonathan Haulenbeek -- Statistical aspects of bioanalytical testing / Arkady M. Gershteyn and Mark Ma -- Bioanalytical aspects in biological therapeutics : biotransformation / Wenying Jian, Cong Wei and Jinping Gan -- New modalities : multidomain therapeutics and gene therapy programs / Kelly Colletti and Mark Ma  -- Regulatory aspects for assay development, validation, and sample analysis / Amy Lavelle and Megan Wiberg.