Technology Transfer Drug Product Manufacturing Process /
Currently, 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 guida...
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| Những tác giả chính: | , , , , |
|---|---|
| Tác giả của công ty: | |
| Định dạng: | Điện tử eBook |
| Ngôn ngữ: | Tiếng Anh |
| Được phát hành: |
Cham :
Springer International Publishing : Imprint: Springer,
2023.
|
| Phiên bản: | 1st ed. 2023. |
| Loạt: | AAPS Introductions in the Pharmaceutical Sciences,
10 |
| Những chủ đề: | |
| Truy cập trực tuyến: | https://doi.org/10.1007/978-3-031-32192-4 |
| Các nhãn: |
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| 100 | 1 | |a Pazhayattil, Ajay Babu. |e author. |0 (orcid)0000-0002-9755-8806 |1 https://orcid.org/0000-0002-9755-8806 |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
| 245 | 1 | 0 | |a Technology Transfer |h [electronic resource] : |b Drug Product Manufacturing Process / |c by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram. |
| 250 | |a 1st ed. 2023. | ||
| 264 | 1 | |a Cham : |b Springer International Publishing : |b Imprint: Springer, |c 2023. | |
| 300 | |a 1 online resource (XIV, 148 p. 78 illus.). |b 55 illus. in color. | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 341 | 0 | |b Table of contents navigation |2 onix | |
| 341 | 0 | |b Single logical reading order |2 onix | |
| 341 | 0 | |b Short alternative textual descriptions |2 onix | |
| 341 | 0 | |b Use of colour is Not sole means of conveying information |2 onix | |
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| 347 | |a text file |b PDF |2 rda | ||
| 490 | 1 | |a AAPS Introductions in the Pharmaceutical Sciences, |x 2522-8358 ; |v 10 | |
| 505 | 0 | |a Chapter 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 | |a Currently, 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 ofthe 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. | ||
| 532 | 8 | |a Accessibility summary: This PDF does Not fully comply with PDF/UA standards but does include limited screen reader support, descriptions for Non-text content (such as images and graphs), bookmarks for easy navigation, and searchable, selectable text. Users of assistive technologies may experience difficulty navigating or interpreting content in this document. We recognise the importance of accessibility and welcome queries about accessibility for any of our products. If you have a question or an access need, please get in touch with us via https://www.springernature.com/gp/info/accessibility | |
| 532 | 8 | |a Inaccessible, or known limited accessibility | |
| 532 | 8 | |a No reading system accessibility options actively disabled | |
| 532 | 8 | |a Publisher contact for further accessibility information: accessibilitysupport@springernature.com | |
| 588 | |a Print version record. | ||
| 650 | 0 | |a Pharmacy. | |
| 650 | 0 | |a Pharmaceutical chemistry. | |
| 650 | 0 | |a Pharmacology. | |
| 650 | 0 | |a Drug delivery systems. | |
| 650 | 0 | |a Pharmacovigilance. | |
| 650 | 1 | 4 | |a Pharmacy. |
| 650 | 2 | 4 | |a Pharmaceutics. |
| 650 | 2 | 4 | |a Pharmacology. |
| 650 | 2 | 4 | |a Drug Delivery. |
| 650 | 2 | 4 | |a Drug Safety and Pharmacovigilance. |
| 700 | 1 | |a Sharma, Sanjay. |e author. |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
| 700 | 1 | |a Philip, Joe Paul. |e author. |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
| 700 | 1 | |a Gischewski-Silva, Michelle. |e author. |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
| 700 | 1 | |a Ingram, Marzena. |e author. |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
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| 773 | 0 | |t Springer Nature eBook | |
| 776 | 0 | 8 | |i Printed edition: |z 9783031321917 |
| 776 | 0 | 8 | |i Printed edition: |z 9783031321931 |
| 776 | 0 | 8 | |i Printed edition: |z 9783031322198 |
| 830 | 0 | |a AAPS Introductions in the Pharmaceutical Sciences, |x 2522-8358 ; |v 10 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/978-3-031-32192-4 |
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