| Description |
1 online resource (viii, 351 pages) : illustrations |
| Series |
Drugs and the pharmaceutical sciences ; 175 |
|
Drugs and the pharmaceutical sciences ; v. 175.
|
| Contents |
1. Overview of protein formulation and delivery / James Wright -- 2. Chemical considerations in protein and peptide stability / Paul M. Bummer -- 3. Physical considerations in protein and peptide stability / Sandy Koppenol -- 4. Analytical methods and stability testing of biopharmaceuticals / Helmut Hoffmann and Sandra Pisch-Heberle -- 5. Preformulation development of protein drugs / Frank K. Bedu-Addo -- 6. Solution formulation of proteins/peptides / Paul McGoff and David S. Scher -- 7. Formulation of leuprolide at high concentration for delivery from a one-year duration implant / Cynthia L. Stevenson -- 8. Freeze-drying concepts : the basics / Larry A. Gatlin [and others] -- 9. Rational choice of excipients for use in lyophilized formulations / Evgenyi Y. Shalaev, Wei Wang, and Larry A. Gatlin -- 10. Formulation of proteins for pulmonary delivery / Andrew R. Clark, Cynthia L. Stevenson, and Steven J. Shire -- 11. Using needle-free injectors for parenteral delivery of proteins / Stephen J. Farr [and others] -- 12. Oral delivery of biopharmaceuticals using the Eligen technology / Ehud Arbit, Shingai Majuru, and Isabel Gomez-Orellana -- 13. Setting specifications and expiration dating for biotechnology products / Carol Hasselbacher, Wassim Nashabeh, and Anthony Mire-Sluis -- 14. Development of drug products : similarities and differences between protein biologics and small synthetic molecules / Eugene J. McNally and Jayne E. Hastedt |
| Summary |
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 addre |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Protein drugs -- Dosage forms.
|
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Proteins -- Conformation.
|
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Drugs -- Design.
|
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Drug stability.
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Protein Conformation
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Drug Delivery Systems
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Drug Design
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Drug Stability
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Proteins -- administration & dosage
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MEDICAL -- Drug Guides.
|
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Proteins -- Conformation
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Drugs -- Design
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Drug stability
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Protein drugs -- Dosage forms
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| Form |
Electronic book
|
| Author |
McNally, Eugene J., 1961-
|
|
Hastedt, Jayne E.
|
| ISBN |
9780849379529 |
|
0849379520 |
|
