Description:Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. Updated and revised, the new edition compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory guidelines. 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. A multi-edited book with chapters authored by leading qualified 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 - Discusses the most pertinent international regulatory guidelines - Covers early derisking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccinesWe have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with Nonclinical Development of Biologics, Vaccines and Specialty Biologics. To get started finding Nonclinical Development of Biologics, Vaccines and Specialty Biologics, you are right to find our website which has a comprehensive collection of manuals listed. Our library is the biggest of these that have literally hundreds of thousands of different products represented.
Pages
484
Format
PDF, EPUB & Kindle Edition
Publisher
Elsevier
Release
2024
ISBN
9789240052451
Nonclinical Development of Biologics, Vaccines and Specialty Biologics
Description: Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. Updated and revised, the new edition compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory guidelines. 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. A multi-edited book with chapters authored by leading qualified 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 - Discusses the most pertinent international regulatory guidelines - Covers early derisking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccinesWe have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with Nonclinical Development of Biologics, Vaccines and Specialty Biologics. To get started finding Nonclinical Development of Biologics, Vaccines and Specialty Biologics, you are right to find our website which has a comprehensive collection of manuals listed. Our library is the biggest of these that have literally hundreds of thousands of different products represented.