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005			20240415165618.0
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007			cr nn 008mamaa
008			230616s2023 sz | fo |||| 0|eng d
020			_a9783031321924
024	7		_a10.1007/978-3-031-32192-4 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aRS192 _b2023 EB
100	1		_aPazhayattil, Ajay Babu _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut _9669176
245	1	0	_aTechnology Transfer : _bDrug Product Manufacturing Process _cby Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram
250			_a1st ed. 2023.
264		1	_aCham _bSpringer International Publishing _c2023
300			_a1 recurso en línea
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490	0		_aAAPS Introductions in the Pharmaceutical Sciences _x2522-8358 _v10
505	0		_aChapter 1: Current Status of Technology Transfer -- Chapter 2: Quality by Design (QbD) Process Design -- Chapter 3: Quality Risk Management (QRM) -- Chapter 4: Technology Transfer Process -- Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies -- Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management -- Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products.
520			_aCurrently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook's authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.
988			_aSpringer_BiomedLife_2023
650		7	_2embne _9161127 _aTecnología farmacéutica
700	1		_956154 _aSharma, Sanjay _eautor
700	1		_9690019 _aPhilip, Joe Paul _eautor
700	1		_9690020 _aGischewski-Silva, Michelle _eautor
700	1		_9690021 _aIngram, Marzena _eautor
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-031-32192-4 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b04/2024 _dz _eb _zSI