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E-raamat: Protein Formulation and Delivery 2nd edition [Taylor & Francis e-raamat]

Edited by , Edited by , Edited by (ALZA Corporation, Mountain View, California, USA)
  • Formaat: 376 pages, 13 Tables, black and white; 6 Halftones, black and white; 64 Illustrations, black and white
  • Sari: Drugs and the Pharmaceutical Sciences
  • Ilmumisaeg: 26-Oct-2007
  • Kirjastus: CRC Press Inc
  • ISBN-13: 9780429134548
  • Taylor & Francis e-raamat
  • Hind: 281,59 €*
  • * hind, mis tagab piiramatu üheaegsete kasutajate arvuga ligipääsu piiramatuks ajaks
  • Tavahind: 402,26 €
  • Säästad 30%
  • Formaat: 376 pages, 13 Tables, black and white; 6 Halftones, black and white; 64 Illustrations, black and white
  • Sari: Drugs and the Pharmaceutical Sciences
  • Ilmumisaeg: 26-Oct-2007
  • Kirjastus: CRC Press Inc
  • ISBN-13: 9780429134548
This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. Because many developments in the field have emerged since the publication of the First Edition, this Second Edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.
Preface iii
Contributors vii
1. Overview of Protein Formulation and Delivery
1
James Wright
2. Chemical Considerations in Protein and Peptide Stability
7
Paul M. Bummer
3. Physical Considerations in Protein and Peptide Stability
43
Sandy Koppenol
4. Analytical Methods and Stability Testing of Biopharmaceuticals
73
Helmut Hoffmann and Sandra Pisch-Heberle
5. Preformulation Development of Protein Drugs
109
Frank K. Bedu-Addo
6. Solution Formulation of Proteins/Peptides
133
Paul MeGoff and David S. Scher
7. Formulation of Leuprolide at High Concentration for Delivery from a One-Year Duration Implant
153
Cynthia L. Stevenson
8. Freeze-Drying Concepts: The Basics
177
Larry A. Gatlin, Tony Auffret, Evgenyi Y. Shalaev, Stanley M. Speaker, and Dirk L. Teagarden
9. Rational Choice of Excipients for Use in Lyophilized Formulations
197
Evgenyi Y. Shalaev, Wei Wang, and Larry A. Gatlin
10. Formulation of Proteins for Pulmonary Delivery 219
Andrew R. Clark, Cynthia L. Stevenson, and Steven J. Shire
11. Using Needle-Free Injectors for Parenteral Delivery of Proteins 255
Stephen J. Farr, Brooks Boyd, Paul Bridges, and Lawrence S. Linn
12. Oral Delivery of Biopharmaceuticals Using the Eligen® Technology 285
Ehud Arbit, Shingai Majuru, and Isabel Gomez-Orellana
13. Setting Specifications and Expiration Dating for Biotechnology Products 303
Carol Hasselbacher, Wassim Nashabeh, and Anthony Mire-Sluis
14. Development of Drug Products: Similarities and Differences Between Protein Biologics and Small Synthetic Molecules 327
Eugene J. McNally and Jayne E. Hastedt
Index 335


Eugene J. McNally, Eugene McNally, Jayne E. Hastedt, Jayne E. Hastedt