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.
1. Chapter 6 : Introduction to vaccines and adjuvants - p. Page 166 2. Chapter 7 : Regulatory aspects of nonclinical vaccine development - p. Page 218 3. Chapter 8 : Special considerations for the nonclinical safety assessment of vaccines - p. Page 236 4. Chapter 9 : Preclinical development of viral vector gene therapies - p. Page 250 5. Chapter 10 : Considerations for nonclinical studies conducted to support the development of cellular therapies - p. Page 301 6. Chapter 11 : Biological therapies for cancer - p. Page 341 7. Chapter 12 : Considerations in the development of pluripotent stem cell–based therapies - p. Page 391 8. Index - p. Page 443
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.
1. Chapter 6 : Introduction to vaccines and adjuvants - p. Page 166 2. Chapter 7 : Regulatory aspects of nonclinical vaccine development - p. Page 218 3. Chapter 8 : Special considerations for the nonclinical safety assessment of vaccines - p. Page 236 4. Chapter 9 : Preclinical development of viral vector gene therapies - p. Page 250 5. Chapter 10 : Considerations for nonclinical studies conducted to support the development of cellular therapies - p. Page 301 6. Chapter 11 : Biological therapies for cancer - p. Page 341 7. Chapter 12 : Considerations in the development of pluripotent stem cell–based therapies - p. Page 391 8. Index - p. Page 443
