東華大學圖書館 |

Language: English

Help

回圖書館首頁

手機版館藏查詢

Back

Switch To: Labeled | MARC Mode | ISBD

Technology transfer = drug product m...

Pazhayattil, Ajay Babu.

Linked to FindBook

Google Book

Amazon

博客來

Technology transfer = drug product manufacturing process /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Technology transfer/ by Ajay Babu Pazhayattil ... [et al.].
Reminder of title:	drug product manufacturing process /
other author:	Pazhayattil, Ajay Babu.
Published:	Cham :Springer International Publishing : : 2023.,
Description:	xiv, 148 p. :ill. (some col.), digital ;24 cm.
[NT 15003449]:	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.
Contained By:	Springer Nature eBook
Subject:	Pharmaceutical technology. -
Online resource:	https://doi.org/10.1007/978-3-031-32192-4
ISBN:	9783031321924

Technology transfer = drug product manufacturing process /
Technology transferdrug product manufacturing process /[electronic resource] :by Ajay Babu Pazhayattil ... [et al.]. - Cham :Springer International Publishing :2023. - xiv, 148 p. :ill. (some col.), digital ;24 cm. - AAPS introductions in the pharmaceutical sciences,102522-8358 ;. - AAPS introductions in the pharmaceutical sciences ;10..

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.

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 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.

ISBN: 9783031321924

Standard No.: 10.1007/978-3-031-32192-4doiSubjects--Topical Terms:

562441
Pharmaceutical technology.

LC Class. No.: RS192

Dewey Class. No.: 615.19

Technology transfer = drug product manufacturing process /
LDR:02957nmm a2200337 a 4500 001 2318378
003 DE-He213
005 20230616163935.0
006 m d
007 cr nn 008maaau
008 230902s2023 sz s 0 eng d
020 $a 9783031321924 $q (electronic bk.)
020 $a 9783031321917 $q (paper)
024 7 $a 10.1007/978-3-031-32192-4 $2 doi
035 $a 978-3-031-32192-4
040 $a GP $c GP
041 0 $a eng
050 4 $a RS192
072 7 $a MQP $2 bicssc
072 7 $a MED072000 $2 bisacsh
072 7 $a MQP $2 thema
082 0 4 $a 615.19 $2 23
090 $a RS192 $b .T255 2023
245 0 0 $a Technology transfer $h [electronic resource] : $b drug product manufacturing process / $c by Ajay Babu Pazhayattil ... [et al.].
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2023.
300 $a xiv, 148 p. : $b ill. (some col.), digital ; $c 24 cm.
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 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.
650 0 $a Pharmaceutical technology. $3 562441
650 0 $a Technology transfer. $3 526217
650 1 4 $a Pharmacy. $3 636101
650 2 4 $a Pharmaceutics. $3 3538434
650 2 4 $a Pharmacology. $3 634543
650 2 4 $a Drug Delivery. $3 3531319
650 2 4 $a Drug Safety and Pharmacovigilance. $3 2108855
700 1 $a Pazhayattil, Ajay Babu. $3 3633346
710 2 $a SpringerLink (Online service) $3 836513
773 0 $t Springer Nature eBook
830 0 $a AAPS introductions in the pharmaceutical sciences ; $v 10. $3 3633347
856 4 0 $u https://doi.org/10.1007/978-3-031-32192-4
950 $a Biomedical and Life Sciences (SpringerNature-11642)