Biological Drug Products (PDF)
Development and Strategies
(Sprache: Englisch)
Tested and proven solutions to the challenges of biological
drug product development
Biological drug products play a central role in combating human
diseases; however, developing new successful biological drugs
presents many challenges, including...
drug product development
Biological drug products play a central role in combating human
diseases; however, developing new successful biological drugs
presents many challenges, including...
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Tested and proven solutions to the challenges of biological
drug product development
Biological drug products play a central role in combating human
diseases; however, developing new successful biological drugs
presents many challenges, including labor intensive production
processes, tighter regulatory controls, and increased market
competition. This book reviews the current state of the science,
offering readers a single resource that sets forth the fundamentals
as well as tested and proven development strategies for biological
drugs. Moreover, the book prepares readers for the challenges that
typically arise during drug development, offering straightforward
solutions to improve their ability to pass through all the
regulatory hurdles and deliver new drug products to the market.
Biological Drug Products begins with general
considerations for the development of any biological drug product
and then explores the strategies and challenges involved in the
development of specific types of biologics. Divided into five
parts, the book examines:
* Part 1: General Aspects
* Part 2: Proteins and Peptides
* Part 3: Vaccines
* Part 4: Novel Biologics
* Part 5: Product Administration/Delivery
Each chapter has been prepared by one or more leading experts in
biological drug development. Contributions are based on a
comprehensive review and analysis of the current literature as well
as the authors' first-hand experience developing and testing new
drugs. References at the end of each chapter serve as a gateway to
original research papers and reviews in the field.
By incorporating lessons learned and future directions for
research, Biological Drug Products enables pharmaceutical
scientists and students to improve their success rate in developing
new biologics to treat a broad range of human diseases.
drug product development
Biological drug products play a central role in combating human
diseases; however, developing new successful biological drugs
presents many challenges, including labor intensive production
processes, tighter regulatory controls, and increased market
competition. This book reviews the current state of the science,
offering readers a single resource that sets forth the fundamentals
as well as tested and proven development strategies for biological
drugs. Moreover, the book prepares readers for the challenges that
typically arise during drug development, offering straightforward
solutions to improve their ability to pass through all the
regulatory hurdles and deliver new drug products to the market.
Biological Drug Products begins with general
considerations for the development of any biological drug product
and then explores the strategies and challenges involved in the
development of specific types of biologics. Divided into five
parts, the book examines:
* Part 1: General Aspects
* Part 2: Proteins and Peptides
* Part 3: Vaccines
* Part 4: Novel Biologics
* Part 5: Product Administration/Delivery
Each chapter has been prepared by one or more leading experts in
biological drug development. Contributions are based on a
comprehensive review and analysis of the current literature as well
as the authors' first-hand experience developing and testing new
drugs. References at the end of each chapter serve as a gateway to
original research papers and reviews in the field.
By incorporating lessons learned and future directions for
research, Biological Drug Products enables pharmaceutical
scientists and students to improve their success rate in developing
new biologics to treat a broad range of human diseases.
Autoren-Porträt
WEI WANG, PhD, is a Research Fellow for PfizerBioTherapeutics Pharmaceutical Sciences. In addition, Dr. Wang is
Adjunct Professor in the School of Pharmacy and Health Sciences at
the University of the Pacific.
MANMOHAN SINGH, PhD, is Head of Technical Development at
Novartis Vaccines and Diagnostics. Dr. Singh has authored over 120
peer-reviewed manuscripts, reviews, and book chapters in the area
of vaccine formulations and adjuvant research. He is also an
Adjunct Professor at the Eshelman School of Pharmacy at University
of North Carolina, Chapel Hill.
Bibliographische Angaben
- 2013, 1. Auflage, 744 Seiten, Englisch
- Herausgegeben: Wei Wang, Manmohan Singh
- Verlag: John Wiley & Sons
- ISBN-10: 1118695038
- ISBN-13: 9781118695036
- Erscheinungsdatum: 10.09.2013
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