Challenge of CMC Regulatory Compliance for Biopharmaceuti
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Item specifics
- Condition
- ISBN
- 9781461469155
- Subject Area
- Science, Medical
- Publication Name
- Challenge of Cmc Regulatory Compliance for Biopharmaceuticals
- Publisher
- Springer New York
- Item Length
- 10 in
- Subject
- Pharmacy, Research, Chemistry / Organic
- Publication Year
- 2013
- Type
- Textbook
- Format
- Hardcover
- Language
- English
- Item Weight
- 323.5 Oz
- Item Width
- 7 in
- Number of Pages
- Xxix, 338 Pages
About this product
Product Identifiers
Publisher
Springer New York
ISBN-10
1461469155
ISBN-13
9781461469155
eBay Product ID (ePID)
159960882
Product Key Features
Number of Pages
Xxix, 338 Pages
Language
English
Publication Name
Challenge of Cmc Regulatory Compliance for Biopharmaceuticals
Subject
Pharmacy, Research, Chemistry / Organic
Publication Year
2013
Type
Textbook
Subject Area
Science, Medical
Format
Hardcover
Dimensions
Item Weight
323.5 Oz
Item Length
10 in
Item Width
7 in
Additional Product Features
Edition Number
2
Intended Audience
Scholarly & Professional
LCCN
2013-933235
Dewey Edition
22
TitleLeading
The
Number of Volumes
1 vol.
Illustrated
Yes
Dewey Decimal
615/.19
Table Of Content
Complexity of Biologica CMC Regulation.- Biologics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Source Materials for Biologics.- Manufacture of the Biologic API.- The Biologic Final Product Process.- Complex Process-Related Impurities.- Molecular Structural Analysis.- Functional Activity (Potency).- Setting Specifications and Expiry Dates.- Demonstrating Product Comparability.- CMC-Focused Regulatory Meetings.- References.
Synopsis
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.), In its new edition, this book reviews the challenges facing quality assurance and control (QA/QC) in today's biopharmaceutical environment, putting into perspective the need for a graded approach to QA/QC from early clinical trials through market approval.
LC Classification Number
RS400-431
Item description from the seller
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Seller feedback (497)
- o***a (211)- Feedback left by buyer.Past 6 monthsVerified purchaseAlthough the incorrect item was sent, the seller was great on communication and resolved the issue immediately. I would definitely work with the seller againLos Angeles Dodgers New Era 2024 City Connect 9FIFTY Snapback Hat - Navy (#355816867338)
- *****- Feedback left by buyer.Past 6 monthsVerified purchaseI got the hat in one piece. Exactly as described. Thanks heaps for that! 🤘🏻 like others, there was no communication from seller, however, it was shipped with no issues.
- *****- Feedback left by buyer.Past 6 monthsVerified purchaseZero communication from this seller the entire time. My transaction was canceled after waiting for this item for roughly two weeks and the answer given was initiated by me which was 100% erroneous. I have been a member of eBay since 2003 and I’ve never had an experience remotely close to this one. First ever seller I will not endorse here in the slightest.