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001 | 978-3-031-32192-4 | ||
003 | DE-He213 | ||
005 | 20240207153619.0 | ||
007 | cr nn 008mamaa | ||
008 | 230616s2023 sz | s |||| 0|eng d | ||
020 |
_a9783031321924 _9978-3-031-32192-4 |
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_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. |
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336 |
_atext _btxt _2rdacontent |
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337 |
_acomputer _bc _2rdamedia |
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338 |
_aonline resource _bcr _2rdacarrier |
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347 |
_atext file _bPDF _2rda |
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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 |
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