Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Herausgeber: Plitnick, Lisa; Herzyk, Danuta

• Gebundenes Buch

Produktbeschreibung

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics is a timely and comprehensive look at the process of nonclinical safety assessment of different types of biopharmaceuticals or biologics. Biologic drugs are a growing and crucial part of the overall pharmaceutical market, largely and generally because they are slightly cheaper to produce, provide higher profit margins and have a higher approval rate than conventional drugs. This reference includes the latest international guidance documents on nonclinical evaluation and a comprehensive review of vaccines, novel biopharmaceuticals, biosimilars and other biologics. By incorporating early de-risking strategies and principles of study design for each type of biopharmaceutical and comparing each to small molecule drugs, this multi-authored book is a valuable resource for all those involved in biologics development.

Produktdetails

• Verlag: Elsevier Science
• Seitenzahl: 432
• Erscheinungstermin: 19. Juli 2013
• Englisch
• Abmessung: 244mm x 192mm x 30mm
• Gewicht: 1082g
• ISBN-13: 9780123948106
• ISBN-10: 012394810X
• Artikelnr.: 38394088

Inhaltsangabe

Preface Acknowledgement Dedication
Section I: Biopharmaceuticals
1. Novel Biopharmaceuticals 2. Global Regulatory Guidances 3. Early
de-risking strategies for Novel Biopharmaceuticals vs. Small Molecule
Drugs  4. PK/PD assessments and Assays 5. Antibody-Drug Conjugates
Section II: Biosimilar Therapeutics
6. Description of Biosimilar Therapeutics and  Compare/contrast Biosimilar
Therapeuticss and Novel Biopharmaceuticals 7. Global Regulatory Guidelines
8. Early characterization of Biosimilar Therapeutics vs. Novel
Biopharmaceuticals/Studies Required and Principles of Study Design/PK/PD
assessments/Assays
Section III: Vaccines
9. Vaccines Description and Comparison/Contrast of Vaccines and Novel
Biopharmaceuticals 10. Global Regulatory Guidances 11. Early de-risking
strategies for Vaccines vs. Novel Biopharmaceuticals 
Section IV: Specialty Biologics and Indications
12. Cell Therapies 13. Gene Therapies 14. Blood Products 15. Oncology Drugs
16. Dual and Multi-Function Modalities 17. Stem Cell-Based Therapeutics