Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Editat de Lisa M. Plitnick, Danuta Herzyken Limba Engleză Hardback – 29 aug 2013
- 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"
- A multi-authored book with chapters written by qualified experts in their respective fields
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Specificații
ISBN-13: 9780123948106
ISBN-10: 012394810X
Pagini: 432
Ilustrații: 50 illustrations
Dimensiuni: 191 x 235 x 30 mm
Greutate: 1.07 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 012394810X
Pagini: 432
Ilustrații: 50 illustrations
Dimensiuni: 191 x 235 x 30 mm
Greutate: 1.07 kg
Editura: ELSEVIER SCIENCE
Public țintă
Pharmaceutical scientists, toxicologists, geneticists, biochemists, cell biologists and immunologists working in the area of biologics within academia, small biotechnology and large pharmaceutical companies.Cuprins
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
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
Recenzii
"…brings nonclinical testing of biological and follow-on biological drugs, vaccines plus cell and gene therapy drugs right up to date. It is written in a very readable, yet highly scientific manner and most of the relevant publications…on the topic are referenced…Overall, a ‘must read’ book for all in the nonclinical field of developing biological drugs." --btsNews, June 2014
"Researchers in pharmaceuticals, toxicology, and other biological sciences summarize the current status of developing medicines from biological material, pointing out where the process is different from developing small-molecule medicines and where it is the same. The topics include regulatory guidelines and their application in the non-clinical evaluation of biological medicines, early de-risking strategy for novel biotherapeutics…" --Reference & Research Book News, December 2013
"Researchers in pharmaceuticals, toxicology, and other biological sciences summarize the current status of developing medicines from biological material, pointing out where the process is different from developing small-molecule medicines and where it is the same. The topics include regulatory guidelines and their application in the non-clinical evaluation of biological medicines, early de-risking strategy for novel biotherapeutics…" --Reference & Research Book News, December 2013