Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "e;biosimilars"e; A multi-authored book with chapters written by qualified experts in their respective fields
Get Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics by at the best price and quality guranteed only at Werezi Africa largest book ecommerce store. The book was published by and it has pages. Enjoy Shopping Best Offers & Deals on books Online from Werezi - Receive at your doorstep - Fast Delivery - Secure mode of Payment
Digital Rights Management (DRM)
The publisher has supplied this book in encrypted form, which means that you need to install free software in order to unlock and read it.
Required software
To read this ebook on a mobile device (phone or tablet) you'll need to install one of these free apps:
To download and read this eBook on a PC or Mac:
-
Adobe Digital Editions
(This is a free app specially developed for eBooks. It's not the same as Adobe Reader, which you probably already have on your computer.)
