000			04684nam a22004095i 4500
999			_c76014 _d76014
001			76014
003			ES-MaUEC
005			20230224084115.0
007			cr nn 008mamaa
008			131012s2013 xxu| s |||| 0|eng d
020			_a9781461479789
024	7		_a10.1007/978-1-4614-7978-9 _2doi
040			_aES-MaUEC
050		4	_aRS199.S73 _bS74 2013 EB
082	0	4	_a615.19
245	0	0	_aSterile product development : _bformulation, process, quality and regulatory considerations _cedited by Parag Kolhe, Mrinal Shah, Nitin Rathore
260			_aNew York _bSpringer International Publishing _c2013
300			_a1 recurso en línea (XVI, 585 p.) _b89 ilustraciones, 67 ilustraciones en color
336			_aTexto (visual) _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490	0		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v6
505	0		_aBasic Principles of Sterile Product Formulation Development -- Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins -- Polymer and Lipid Based Systems for Parenteral Drug Delivery -- Formulation Approaches and Strategies for PEGylated Biotherapeutics -- Nasal Delivery -- Formulation Approaches and Strategies for Vaccines and Adjuvants -- Challenges in Freeze-Thaw Processing of Bulk Protein Solutions -- Best Practices for Technology Transfer of Sterile Products: Case Studies -- Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations -- Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology -- Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals -- Advances in Container Closure Integrity Testing -- Pen and Autoinjector Drug Delivery Devices -- Particulate Matter in Sterile Parenteral Products -- Appearance Evaluation of Parenteral Pharmaceutical Products -- Sterile Filtration Principles, Best Practices and New Developments -- Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance -- Basics of Sterilization Methods -- Avoiding Common Errors during Viable Microbial Contamination Investigations -- Validation of Rapid Microbiology Methods (RMMs) -- Validation of Moist and Dry Heat Sterilization
520			_aThis comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: {u2022} Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines {u2022} Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures {u2022} Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development
650	0	7	_aDrogas _0LocalV _2embne _9139235
650		7	_aIndustria farmacéutica _xControl de calidad _9138366 _0comprobar BNE19912896162 _2embne
700	1		_aKolhe, Parag _eeditor literario _984816 _0Local
700	1		_aShah, Mrinal _eeditor literario _984817 _0Local
700	1		_aRathore, Nitin _eeditor literario _984818 _0Local
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4614-7978-9 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
901			_ai9781461479789
907			_a.b12816322 _b10-10-17 _c01-10-14
942			_2lcc _cLE
945			_aRS199 .S73 S74 2013 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11545707 _z06-04-17
988			_aEBOOK, EBSPRINGERrevisado
998			_am _a_alco _a_vill _b08-05-17 _cm _dz _eb _feng _gxxu _h0