MARC details
000 -LIDER |
fixed length control field |
04529nam a22006615i 4500 |
001 - CONTROL NUMBER |
control field |
978-3-031-32192-4 |
003 - CONTROL NUMBER IDENTIFIER |
control field |
DE-He213 |
005 - DATE AND TIME OF LATEST TRANSACTION |
control field |
20240207153619.0 |
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
fixed length control field |
cr nn 008mamaa |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
230616s2023 sz | s |||| 0|eng d |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
International Standard Book Number |
9783031321924 |
-- |
978-3-031-32192-4 |
050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
Classification number |
RS1-441 |
072 #7 - SUBJECT CATEGORY CODE |
Subject category code |
MQP |
Source |
bicssc |
072 #7 - SUBJECT CATEGORY CODE |
Subject category code |
MED072000 |
Source |
bisacsh |
072 #7 - SUBJECT CATEGORY CODE |
Subject category code |
MQP |
Source |
thema |
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
Classification number |
615.1 |
Edition number |
23 |
100 1# - MAIN ENTRY--PERSONAL NAME |
Personal name |
Pazhayattil, Ajay Babu. |
Relator term |
author. |
Relator code |
aut |
-- |
http://id.loc.gov/vocabulary/relators/aut |
245 10 - TITLE STATEMENT |
Title |
Technology Transfer |
Medium |
[electronic resource] : |
Remainder of title |
Drug Product Manufacturing Process / |
Statement of responsibility, etc. |
by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram. |
250 ## - EDITION STATEMENT |
Edition statement |
1st ed. 2023. |
264 #1 - |
-- |
Cham : |
-- |
Springer International Publishing : |
-- |
Imprint: Springer, |
-- |
2023. |
300 ## - PHYSICAL DESCRIPTION |
Extent |
XIV, 148 p. 78 illus., 55 illus. in color. |
Other physical details |
online resource. |
336 ## - |
-- |
text |
-- |
txt |
-- |
rdacontent |
337 ## - |
-- |
computer |
-- |
c |
-- |
rdamedia |
338 ## - |
-- |
online resource |
-- |
cr |
-- |
rdacarrier |
347 ## - |
-- |
text file |
-- |
PDF |
-- |
rda |
490 1# - SERIES STATEMENT |
Series statement |
AAPS Introductions in the Pharmaceutical Sciences, |
International Standard Serial Number |
2522-8358 ; |
Volume/sequential designation |
10 |
500 ## - GENERAL NOTE |
General note |
Acceso multiusuario |
505 0# - FORMATTED CONTENTS NOTE |
Formatted contents note |
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 ## - SUMMARY, ETC. |
Summary, etc. |
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. |
541 ## - IMMEDIATE SOURCE OF ACQUISITION NOTE |
Owner |
UABC ; |
Method of acquisition |
Perpetuidad |
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Pharmacy. |
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Pharmaceutical chemistry. |
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Pharmacology. |
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Drug delivery systems. |
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Pharmacovigilance. |
650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Pharmacy. |
650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Pharmaceutics. |
650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Pharmacology. |
650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Drug Delivery. |
650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Término temático o nombre geográfico como elemento de entrada |
Drug Safety and Pharmacovigilance. |
700 1# - ADDED ENTRY--PERSONAL NAME |
Personal name |
Sharma, Sanjay. |
Relator term |
author. |
Relator code |
aut |
-- |
http://id.loc.gov/vocabulary/relators/aut |
700 1# - ADDED ENTRY--PERSONAL NAME |
Personal name |
Philip, Joe Paul. |
Relator term |
author. |
Relator code |
aut |
-- |
http://id.loc.gov/vocabulary/relators/aut |
700 1# - ADDED ENTRY--PERSONAL NAME |
Personal name |
Gischewski-Silva, Michelle. |
Relator term |
author. |
Relator code |
aut |
-- |
http://id.loc.gov/vocabulary/relators/aut |
700 1# - ADDED ENTRY--PERSONAL NAME |
Personal name |
Ingram, Marzena. |
Relator term |
author. |
Relator code |
aut |
-- |
http://id.loc.gov/vocabulary/relators/aut |
710 2# - ADDED ENTRY--CORPORATE NAME |
Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
773 0# - HOST ITEM ENTRY |
Title |
Springer Nature eBook |
776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
Relationship information |
Printed edition: |
International Standard Book Number |
9783031321917 |
776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
Relationship information |
Printed edition: |
International Standard Book Number |
9783031321931 |
776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
Relationship information |
Printed edition: |
International Standard Book Number |
9783031322198 |
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
Uniform title |
AAPS Introductions in the Pharmaceutical Sciences, |
-- |
2522-8358 ; |
Volume number/sequential designation |
10 |
856 40 - ELECTRONIC LOCATION AND ACCESS |
Public note |
Libro electrónico |
Uniform Resource Identifier |
http://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-32192-4 |
912 ## - |
-- |
ZDB-2-SBL |
912 ## - |
-- |
ZDB-2-SXB |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Libro Electrónico |