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03801nam a22003495i 4500 |
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978-1-4939-2316-8 |
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20191027152532.0 |
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cr nn 008mamaa |
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150401s2015 xxu| s |||| 0|eng d |
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|a 9781493923168
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|a 10.1007/978-1-4939-2316-8
|2 doi
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|a Sistema de Bibliotecas del Tecnológico de Costa Rica
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|a Quality by Design for Biopharmaceutical Drug Product Development
|c edited by Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe.
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| 250 |
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|a 1st ed. 2015.
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|a New York, NY :
|b Springer New York :
|b Imprint: Springer,
|c 2015.
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| 300 |
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|a XX, 710 p. 214 illus., 163 illus. in color.
|b online resource.
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| 336 |
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|a text
|b txt
|2 rdacontent
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
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|a AAPS Advances in the Pharmaceutical Sciences Series,
|v 18
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|a 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.
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| 650 |
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|a Pharmacology.
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| 650 |
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|a Medicine.
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| 650 |
1 |
4 |
|a Pharmacology/Toxicology.
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| 650 |
2 |
4 |
|a Biomedicine, general.
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| 700 |
1 |
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|a Jameel, Feroz.
|e editor.
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| 700 |
1 |
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|a Hershenson, Susan.
|e editor.
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| 700 |
1 |
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|a Khan, Mansoor A.
|e editor.
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| 700 |
1 |
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|a Martin-Moe, Sheryl.
|e editor.
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| 710 |
2 |
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|a SpringerLink (Online service)
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| 773 |
0 |
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|t Springer eBooks
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| 856 |
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|u https://doi.org/10.1007/978-1-4939-2316-8
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