Translating Molecular Biomarkers into Clinical Assays / AAPS Advances in the Pharmaceutical Sciences Series Bd.21 (PDF)
Techniques and Applications
(Sprache: Englisch)
This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation...
sofort als Download lieferbar
Printausgabe 160.49 €
eBook (pdf) -7%
149.79 €
74 DeutschlandCard Punkte sammeln
- Lastschrift, Kreditkarte, Paypal, Rechnung
- Kostenloser tolino webreader
Produktdetails
Produktinformationen zu „Translating Molecular Biomarkers into Clinical Assays / AAPS Advances in the Pharmaceutical Sciences Series Bd.21 (PDF)“
This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation of new cytometry methods. Expertly curated by two practicing professionals in drug development and biotherapeutics, individual chapters are selected for novel and sound research; information is chosen based on its relevance to lab applications and clinical trials, such as the topic of selecting animal models for their relevancy to humans. The book is multifaceted, discussing the ethics and issues with biospecimens and providing an in-depth analysis to the differences between pre-clinical and clinical assay development. The book is an essential read for general readers who need an introduction to the history and background of biomarkers, and it also provides critical analyses of various new validation methods for practitioners and researchers.
Autoren-Porträt
Russell Weiner is a senior level biopharmaceutical professional with expertise in pharmaceutical and biologic drug development, clinical trial conduct, regulated bioanalysis, use of biomarkers in early clinical decision making and developing companion diagnostic strategies. He is the Executive Director and head of Clinical Bioanalytical, Biomarkers and Companion Diagnostics team at Daiichi Sankyo Inc. He acquired his Ph.D. at the Albany Medical College. Dr. Weiner led clinical development teams responsible for transitioning therapeutics from discovery through phase two 'proof-of-concept' studies. With over 40 publications, he is also part of the Foundation of the NIH Cancer Steering Committee for The Biomarkers Consortium. Marian Kelley is a leading expert in biotherapeutic drug development from biomarker application to assay analysis. She is the president and founder of MKelley Consulting, LLC, a company that provides bioanalytical support in drug development including validation of biomarker methods, immunogenicity and pharmacokinetic studies, and cell-based assays. Marian was the founding secretary of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG); she co-chaired the Workshop on Assay Reproducibility for Incurred Samples held in Crystal City; and most recently, she leads the L1 global harmonization team on Run Acceptance for LBA resulting in a published white paper. Kelley is coauthor or coeditor of over 30 publications. She is also an extensively experienced trainer in validation of methods and quality control.
Bibliographische Angaben
- 2016, 1st ed. 2016, 212 Seiten, Englisch
- Herausgegeben: Russell Weiner, Marian Kelley
- Verlag: Springer-Verlag GmbH
- ISBN-10: 3319407937
- ISBN-13: 9783319407937
- Erscheinungsdatum: 22.08.2016
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
eBook Informationen
- Dateiformat: PDF
- Größe: 3.09 MB
- Ohne Kopierschutz
- Vorlesefunktion
Sprache:
Englisch
Kommentar zu "Translating Molecular Biomarkers into Clinical Assays / AAPS Advances in the Pharmaceutical Sciences Series Bd.21"
0 Gebrauchte Artikel zu „Translating Molecular Biomarkers into Clinical Assays / AAPS Advances in the Pharmaceutical Sciences Series Bd.21“
Zustand | Preis | Porto | Zahlung | Verkäufer | Rating |
---|
Schreiben Sie einen Kommentar zu "Translating Molecular Biomarkers into Clinical Assays / AAPS Advances in the Pharmaceutical Sciences Series Bd.21".
Kommentar verfassen