Lavoisier S.A.S.
14 rue de Provigny
94236 Cachan cedex
FRANCE

Heures d'ouverture 08h30-12h30/13h30-17h30
Tél.: +33 (0)1 47 40 67 00
Fax: +33 (0)1 47 40 67 02


Url canonique : www.lavoisier.fr/livre/medecine/nonclinical-development-of-biologics-biosimilars-vaccines-and-specialty-biologics/descriptif_4979384
Url courte ou permalien : www.lavoisier.fr/livre/notice.asp?ouvrage=4979384

Nonclinical Development of Biologics, Vaccines and Specialty Biologics (2nd Ed.)

Langue : Anglais

Coordonnateurs : Plitnick Lisa, Fuller Claudette LaTonya

Couverture de l’ouvrage Nonclinical Development of Biologics, Vaccines and Specialty Biologics

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. This multi-edited book with chapters authored by leading qualified experts in the field offers a comprehensive reference on critical insights that will be of interest to researchers involved in early through late-stage biologics.

Section I: Development of Biopharmaceuticals 1. Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development 2. Nonclinical Development of Monovalent and Polyvalent Biopharmaceuticals 3. Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines 4. Early De-risking Strategy for Novel Biotherapeutics 5. Pharmacokinetics, Pharmacodynamics, and Bioanalytics 6. Overview, Regulatory Expectations and Early Characterization of Biosimilar Therapeutics Section II: Vaccines 7. Introduction to Vaccines and Adjuvants 8. Global Regulatory Guidelines for Vaccines 9. Special Considerations for the Nonclinical Safety Assessment of Vaccines Section III: Specialty Biologics and Indications 10. Gene Therapy 11. Cell Therapy 12. Biological Therapies for Cancer 13. Considerations in the Development of Pluripotent Stem Cell-based Therapies

Dr. Lisa Plitnick received a BA in Biology from The State University of New York at Oswego and an MS and a PhD in Immunology from the Albany Medical College in Albany, New York. In 2002, she joined the Department of Safety Assessment and Laboratory Animal Resources in Merck Research Laboratories where she worked as a Study Director and currently serves as the Preclinical Safety Lead on drug development teams and as the Therapeutic Area Lead for Vaccines. She is the Scientific and Regulatory Advisor for the In Vivo Biologics Release Testing Group in the Merck Manufacturing Division and the Scientific Advisor for the Immunotoxicology Laboratory. Dr. Plitnick has edited a book, contributed to several book chapters on biologics and vaccines, and peer-reviewed journal articles. She is a member of the HESI ILSI Immunotoxicology Technical Committee, the BioSafe Specialty Biologics Expert and MoA/MoT working groups, and the Merck Immunotoxicology Council.
Dr. Claudette (Tonya) Fuller completed her PhD in Viral Immunology at the University of Virginia. She completed postdoctoral work at the University of Texas Medical Branch and National Cancer Institute - National Institutes of Health, focusing on molecular immunology. She currently serves as a Therapeutic Area Leader for Infectious Disease at Merck Research Laboratories in West Point, Pennsylvania, USA.
As Therapeutic Area Leader, she is responsible for overseeing the nonclinical development of antibacterial and antifungal programs within the Infectious Disease Therapy Area at Merck where is she is also the co-chair of the ImmunoTox and Biologics Advisory Council that provides expert opinion to all stages of drug discovery and development programs. She is a proven leader in the nonclinical drug development in multiple therapeutic areas (Biologics, Immunology, Immuno-Oncology, Virology, and Anti-Bacterials). She enjoys building and leading diverse and inclusive nonclinical drug safety/operations teams to strategical
  • 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"
  • Updated and revised, with new chapters on nonclinical development of monovalent and polyvalent biopharmaceuticals; pharmacokinetics, pharmacodynamics, and bioanalytics; regulatory expectations and early characterization of biosimilar therapeutics; and cell and gene therapies

Date de parution :

Ouvrage de 450 p.

19x23.3 cm

À paraître, réservez-le dès maintenant

171,65 €

Ajouter au panier