000 05479nam a22004575i 4500
999 _c120620
_d120620
001 120620
003 ES-MaUEC
005 20230102114051.0
006 a||||fo|||| 00| 0
007 cr nn nnnaamaa
008 200610s2020 gw a o |||| 0|eng d
020 _a9783030415242
024 7 _a10.1007/978-3-030-41524-2
_2doi
040 _aES-MaUEC
_bspa
_cES-MaUEC
_dES-MaUEC
050 4 _aRS380
_b2020 EB
245 0 0 _aContinuous Pharmaceutical Processing
_cedited by Zoltan K Nagy, Arwa El Hagrasy, Jim Litster
250 _aFirst edition
264 1 _aCham, Switzerland
_bSpringer International Publishing
_c2020
300 _a1 recurso en línea (VIII, 541 páginas)
_b248 ilustraciones, 189 ilustraciones a color
336 _2rdacontent
_aTexto
_btxt
337 _2rdamedia
_aelectrónico
_bc
338 _2rdacarrier
_arecurso electrónico
_bcr
347 _aArchivo de texto
_bPDF
490 0 _aAAPS Advances in the Pharmaceutical Sciences Series
_x2210-7371
_v42
490 0 _aBiomedical and Life Sciences (Springer-11642)
505 0 _aBasic Principles of Continuous Manufacturing -- Continuous Reactors for Pharmaceutical Manufacturing -- Understanding Residence Time, RTD, and Impact of Surge Vessels -- Practical Considerations for Continuous Drug Substance Manufacturing -- Continuous Crystallization: Equipment and Operation -- Continuous Feeding-Blending in Pharmaceutical Continuous Manufacturing -- Recent Progress in Roll Compaction Process Development for Pharmaceutical Solid Dosage Form Manufacture -- Continuous wet granulation processes -- Fluidized Bed Drying -- Statistical Methods in Quality by Design and Process Analytical Technologies for continuous processes to enable real-time release -- Active Process Control in Pharmaceutical Continuous Manufacturing-The Quality by Control (QbC) Paradigm -- Real-time Optimization in Pharmaceutical Manufacturing -- Safety Guidelines for Continuous Chemistry Experimental Work in the Laboratory -- Evaluating the Busieness/Supply Chain Benefits of Continuous Processing in Pharmaceuticals -- Regulatory Considerations for Continuous Manufacturing.
520 3 _aContinuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology. .
988 _aSpringer_Biomedlife_23062020
650 7 _aBiotecnología farmacéutica
_2embne
_9155839
700 1 _aNagy, Zoltan K
_eeditor
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
_1http://viaf.org/viaf/5257158261783902540004
700 1 _aEl Hagrasy, Arwa
_eeditor
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aLitster, Jim
_eeditor
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
_0http://id.loc.gov/authorities/names/n2003003767
_1http://viaf.org/viaf/29789049
710 2 _aSpringerLink (Online service)
_0http://id.loc.gov/authorities/names/no2005046756
_1http://viaf.org/viaf/148105729
776 0 8 _iPrinted edition:
_z9783030415235
776 0 8 _iPrinted edition:
_z9783030415259
776 0 8 _iPrinted edition:
_z9783030415266
830 0 _aAAPS Advances in the Pharmaceutical Sciences Series,
_x2210-7371 ;
_v42
856 4 0 _uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-41524-2
_zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942 _2lcc
_cLE
998 _b07/2020
_dz
_eo
_zSI