Biosimilar Clinical Development: Scientific Considerations and New Methodologies - Brossura

Brossura

ISBN 10: 0367736527 ISBN 13: 9780367736521

Casa editrice: Routledge, 2020

Riassunto

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.

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Informazioni sull'autore

Dr. Kerry B. Barker is the Vice-President and Head of Early Oncology Research Statistics at Pfizer, Dr. Sandeep Menon is the Vice-President and Head of Biostatistics Research and Consulting Center at Pfizer , Dr. Ralph D’Agostino is a professor of Mathematics and Statistics at Boston University, Dr. Siyan Xu is a senior principal biostatistician at Novartis and Dr.Bo Jin is the Director of Biostatistics in Early Oncology Research at Pfizer. All have been involved with biosimilars clinical development across all regions of the world.

Dettagli dell'edizione

• Editore: Routledge
• Data di pubblicazione: 2020
• Lingua: Inglese
• ISBN 10: 0367736527
• ISBN 13: 9780367736521
• Rilegatura: Copertina flessibile
• Numero edizione: 1
• Numero di pagine: 248
• Redattore: Barker Kerry B., Menon Sandeep M., D'Agostino Sr. Ralph B., Xu Siyan, Jin PhD Bo
• Contatto del produttore: Taylor and Francis, GPSR Taylor and Francis; gpsr@taylorandfrancis.com; ; Taylor & Francis Verlag GmbH, Kaufingerstraße 24; München; 80331; Germania