000			03825nam a2200469 i 4500
988			_aSpringer_BiomedLife_2019
999			_c115821 _d115821 _x1
001			115821
003			ESmaUEC
005			20240415163542.0
006			a||||fo|||| 00| 0
007			cr nn nnnaamaa
008			190830s2019 gw | s |||| 0|eng d
020			_a9783030274849
024	7		_a10.1007/978-3-030-27484-9 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aRS201 .S57 _b2019 EB
100	1		_aPazhayattil, Ajay Babu _eautor _9669176
245	1	0	_aSolid oral dose process validation _nVolume two : _blifecycle approach application _cby Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins
250			_aFirst edition
264		1	_aCham, Switzerland _bSpringer International Publishing _c2019
300			_a1 recurso en línea (XII, 108 páginas) _b83 ilustraciones, 60 ilustraciones a color
336			_aTexto _btxt _2rdacontent
337			_2rdamedia _aelectrónico _bc
338			_2rdacarrier _arecurso electrónico _bcr
347			_atext file _bPDF
490	0		_aAAPS Introductions in the Pharmaceutical Sciences _x2522-834X
490	0		_aBiomedical and Life Sciences (Springer-11642)
505	0		_aPreface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies -- Chapter 2: Stage 1 Scale Up, Tech Transfer Process -- Considerations for process scale up and transfer -- Chapter 3: Stage 2 Batch determination, Sampling & Testing Plan -- PPQ batch determination method, scientifically supported sampling and testing plans -- Chapter 4: Stage 3A Continued Process Verification -- Stage 3A assessment methodology for newly launched products -- Chapter 5: Stage 3B Continued Process Verification -- Routine CPV monitoring plan for commercial products.
520	3		_aThe textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.
650		7	_aFormas farmacéuticas sólidas _9668462 _2embne
650		7	_aMedicación oral _9164630 _2embne
650		7	_aMedicamentos _0embne _9173033 _xAdministración
700	1		_aSayeed-Desta, Naheed. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
700	1		_aFredro-Kumbaradzi, Emilija. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
700	1		_aIngram, Marzena. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
700	1		_aCollins, Jordan. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
776	0	8	_iPrinted edition: _z9783030274832
776	0	8	_iPrinted edition: _z9783030274856
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-27484-9 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_aSI _cm _dz _feng _ggw _h0 _b01/2020 _eel _zSI