Nonclinical Development of Biologics, Vaccines and Specialty Biologics 2nd Edition

Grab the definitive guide for modern biologics development: Nonclinical Development of Biologics, Vaccines and Specialty Biologics, 2nd Edition by Lisa M. Plitnick and Claudette L. Fuller. This updated edition is essential for scientists, regulatory affairs professionals, and project leaders navigating preclinical strategies that bridge discovery and first-in-human studies.

Dive into clear, practical guidance on designing robust nonclinical programs for monoclonal antibodies, recombinant proteins, vaccines, gene therapies, and other specialty biologics. Chapters cover safety pharmacology, toxicology study design, immunogenicity assessment, species selection, dose translation, and PK/PD modeling — all framed with global regulatory expectations from the FDA, EMA and other international authorities. Real-world case studies and decision trees make complex topics approachable and immediately applicable to IND-enabling programs and global submissions.

Why this book matters: it synthesizes scientific depth with regulatory insight so teams can accelerate development timelines while managing risk. Whether you work in biotech, CROs, or regulatory agencies in North America, Europe, Asia or beyond, you’ll find strategies to optimize study design, interpret safety data, and align nonclinical packages with regulatory pathways worldwide.

Practical, authoritative, and up-to-date, this 2nd edition helps you turn preclinical data into confident regulatory decisions. Add Nonclinical Development of Biologics, Vaccines and Specialty Biologics to your library to support safer, faster translation from bench to bedside. Order now to strengthen your nonclinical strategy and stay competitive in the global biologics landscape.

Note: eBooks do not include supplementary materials such as CDs, access codes, etc.