Jordanian Union Catalogue

Search Libraries Catalogue

Search

Options

Refine

Start Over

Show details

Duplicate Items

Add to My List

Print

Sorts and Limits

Sorts:

Title: Quality by design for biopharmaceutical drug product development / Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, editors.
AAPS advances in the pharmaceutical sciences series ;
AAPS Advances in the Pharmaceutical Sciences Series ;
Main Entry: Jameel, Feroz, editor.
Hershenson, Susan, editor.
Khan, Mansoor A., editor.
Martin-Moe, Sheryl, editor.
Jameel, Feroz. editor.
Hershenson, Susan. editor.
Khan, Mansoor A. editor.
Martin-Moe, Sheryl. editor.
Publisher: Springer,
Publication Date: [2015]
Publication Place: New York :
ISBN: 9781493923151 (alk. paper)
1493923153 (alk. paper)
9781493923168 (eBook)
Subject: Drugs -- Design.
Pharmaceutical technology -- Quality control.
Pharmaceutical biotechnology.
Biopharmaceutics.
Drug Discovery.
Drug Compounding.
Pharmaceutical Preparations -- standards.
Quality Control.
Technology, Pharmaceutical.
Drugs -- Design.
Pharmaceutical biotechnology.
Pharmaceutical technology -- Quality control.
Series: AAPS advances in the pharmaceutical sciences series ; volume 18
AAPS Advances in the Pharmaceutical Sciences Series ; v.18.
Contents: 1 Challenges and Opportunities for Biotech Quality by Design -- 2 Lessons Learned From Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program -- 3 Definitions and Scope of Key Elements of QbD -- 4 An Overview of Quality by Design for Drug Product -- 5 Development of Drug Product Formulations: Molecular Design and Early Candidates Screening -- 6 Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Formulations -- 7 Application of QbD Principles to Late-stage Formulation Development for Biological Liquid Products -- 8 Application of QbD Principles for Lyophilized Formulation Development -- 9 Drug Substance Frozen Storage and Thawing -- 10 Quality by Design as Applied to Drug Substance Formulation using Ultrafiltration and Diafiltration -- 11 A QbD Approach in the Development and Scale-up of Mixing Processes -- 12 Application of QbD Elements in the Development and Scale-up of a Commercial Filtration Process -- 13 Application of QbD Elements in the Development and Scale-up of Commercial Filling Process -- 14 Lyophilization Process Design and Development Using QbD Principles -- 15 Visible and Subvisible Protein Particle Inspection Within a QbD-based Strategy -- 16 Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products -- 17 Quality by Design for Primary Container Components -- 18 Devices and Combination Products for Biopharmaceuticals -- 19 Applicability of QbD for Vaccine Drug Product Development -- 20 Automation and High Throughput Technologies in Biopharmaceutical Drug Product Development with QbD Approaches -- 21 Critical Quality Attributes, Specifications, and Control Strategy -- 22 Multivariate Analysis for Process Understanding, Monitoring, Control and Optimization in Lyophilization Processes -- 23 Using Mathematical Modeling and Prior Knowledge for QbD in Freeze-drying Processes -- 24 Application of Multivariate Statistical Process Monitoring to Lyophilization Process -- 25 Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process -- 26 Product Homogeneity Assessment during Validation of Biopharmaceutical Drug Product Manufacturing Processes -- 27 Application of Quality by Design Principles to the Drug Product Technology Transfer Process -- 28 Regulatory Considerations For Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management.

Cover Image:

http://images.amazon.com/images/P/9781493923168 (eBook).jpg

http://images.amazon.com/images/P/9781493923151 (alk. paper).jpg

http://images.amazon.com/images/P/1493923153 (alk. paper).jpg

Agency:	Collection:	Call No.:	Item Type:	Status:	Copy:	Barcode:	Media Type:
German	General	RS380 .Q35 2015	Normal Circulation	Available	1	GJU025397	Book
JUST Main Library	Electronic Resources		No Circulation	Available Online		-705589	Book