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008			150401s2015 xxu| s |||| 0|eng d
020			_a9781493923168
024	7		_a10.1007/978-1-4939-2316-8 _2doi
050		4	_aRS380 _b.Q355 2015 EB
082	0	4	_a615
245	0	0	_aQuality by Design for Biopharmaceutical Drug Product Development _cedited by Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe
260			_aNew York _bSpringer _c2015
300			_a1 recurso en línea (XX, 710 p.) _b214 ilustraciones, 163 ilustraciones en color
336			_aTexto (visual) _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490	1		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v18
505	0		_a1 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
520	3		_aThis volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Â{u0321}ter chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs
710	2		_aSpringerLink (Online service) _0Local _9106996
942			_2lcc _cLE
988			_aEBOOK, EBSPRINGER
650		7	_aBiotecnología farmacéutica _9155839 _0comprobar BNE19996549239 _2embne
700	1		_aJameel, Feroz _eeditor literario _993475 _0Local
700	1		_aHershenson, Susan _eeditor literario _993476 _0Local
700	1		_aKhan, Mansoor A. _eeditor literario _993477 _0Local
700	1		_aMartin-Moe, Sheryl _eeditor literario _993478 _0Local
830		0	_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v18 _9133175
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4939-2316-8 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
901			_ai9781493923168
907			_a.b12897784 _b10-10-17 _c18-01-16
998			_am _a_alco _a_vill _b19-09-17 _cm _dz _ek _feng _gxxu _h0
945			_aRS380 .Q355 2015 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11567405 _z06-04-17
999			_c81188 _d81188 _x1