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020 _a9783031321924
_9978-3-031-32192-4
050 4 _aRS1-441
072 7 _aMQP
_2bicssc
072 7 _aMED072000
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072 7 _aMQP
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082 0 4 _a615.1
_223
100 1 _aPazhayattil, Ajay Babu.
_eauthor.
_4aut
_4http://id.loc.gov/vocabulary/relators/aut
245 1 0 _aTechnology Transfer
_h[electronic resource] :
_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 :
_bImprint: Springer,
_c2023.
300 _aXIV, 148 p. 78 illus., 55 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _aAAPS Introductions in the Pharmaceutical Sciences,
_x2522-8358 ;
_v10
500 _aAcceso multiusuario
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.
541 _fUABC ;
_cPerpetuidad
650 0 _aPharmacy.
650 0 _aPharmaceutical chemistry.
650 0 _aPharmacology.
650 0 _aDrug delivery systems.
650 0 _aPharmacovigilance.
650 1 4 _aPharmacy.
650 2 4 _aPharmaceutics.
650 2 4 _aPharmacology.
650 2 4 _aDrug Delivery.
650 2 4 _aDrug Safety and Pharmacovigilance.
700 1 _aSharma, Sanjay.
_eauthor.
_4aut
_4http://id.loc.gov/vocabulary/relators/aut
700 1 _aPhilip, Joe Paul.
_eauthor.
_4aut
_4http://id.loc.gov/vocabulary/relators/aut
700 1 _aGischewski-Silva, Michelle.
_eauthor.
_4aut
_4http://id.loc.gov/vocabulary/relators/aut
700 1 _aIngram, Marzena.
_eauthor.
_4aut
_4http://id.loc.gov/vocabulary/relators/aut
710 2 _aSpringerLink (Online service)
773 0 _tSpringer Nature eBook
776 0 8 _iPrinted edition:
_z9783031321917
776 0 8 _iPrinted edition:
_z9783031321931
776 0 8 _iPrinted edition:
_z9783031322198
830 0 _aAAPS Introductions in the Pharmaceutical Sciences,
_x2522-8358 ;
_v10
856 4 0 _zLibro electrónico
_uhttp://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-32192-4
912 _aZDB-2-SBL
912 _aZDB-2-SXB
942 _cLIBRO_ELEC
999 _c261870
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