Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics is popular PDF and ePub book, written by Lisa M. Plitnick in 2013-06-27, it is a fantastic choice for those who relish reading online the Medical genre. Let's immerse ourselves in this engaging Medical book by exploring the summary and details provided below. Remember, Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics can be Read Online from any device for your convenience.
Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics Book PDF Summary
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 "biosimilars" - A multi-authored book with chapters written by qualified experts in their respective fields
Detail Book of Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics PDF
- Author : Lisa M. Plitnick
- Release : 27 June 2013
- Publisher : Academic Press
- ISBN : 9780123948236
- Genre : Medical
- Total Page : 441 pages
- Language : English
- PDF File Size : 11,5 Mb
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