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Biosimilars and interchangeable biologics : strategic elements / Sarfaraz K. Niazi, Therapeutic Proteins International LLC, Chicago, Illinois, USA.

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Format:
Book
Author/Creator:
Niazi, Sarfaraz, 1949- author.
Contributor:
CRCnetBASE.
Language:
English
Subjects (All):
Pharmaceutical biotechnology.
Biopharmaceutics.
Genre:
Electronic books.
Physical Description:
1 online resource
Place of Publication:
Boca Raton : CRC Press, [2016]
System Details:
text file
Contents:
1. Introduction to biosimilar and interchangeable products
2. Intellectual property issues
3. European regulatory guidance
4. EMA-approved biosimilars
5. The FDA regulatory guidance
6. The ROW regulatory guidance
7. U.S. commercialization
8. Global commercialization
9. Quality and lifecycle management.
Notes:
Includes bibliographical references and index.
Other Format:
Print version:
ISBN:
9781498743488
OCLC:
930992556
Access Restriction:
Restricted for use by site license.

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