Biosimilars : design and analysis of follow-on biologics
Shein-Chung Chow
"This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies under various study designs at various stages of research and development of biologic products"--"Biologic drug products are therapeutic moieties that are manufactured using a living system or organism. These are important life-saving drug products for patients with unmet medical needs. They also comprise a growing segment in the pharmaceutical industry. In 2007, for instance, worldwide sales of biological products reached $94 billion US dollars, accounting for about 15% of the pharmaceutical industry's gross revenue. Meanwhile, many biological products face losing their patents in the next decade"-- Read more... Abstract: "This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies under various study designs at various stages of research and development of biologic products"--"Biologic drug products are therapeutic moieties that are manufactured using a living system or organism. These are important life-saving drug products for patients with unmet medical needs. They also comprise a growing segment in the pharmaceutical industry. In 2007, for instance, worldwide sales of biological products reached $94 billion US dollars, accounting for about 15% of the pharmaceutical industry's gross revenue. Meanwhile, many biological products face losing their patents in the next decade"
Կատեգորիաներ:
Տարի:
2014
Հրատարակչություն:
Taylor & Francis
Լեզու:
english
Էջեր:
444
ISBN 10:
1466579692
ISBN 13:
9781466579699
Սերիաներ:
Chapman & Hall/CRC biostatistics series, 60
Ֆայլ:
PDF, 10.10 MB
IPFS:
,
english, 2014