Technology Transfer (Registro nro. 261870)

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 ## -
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912 ## -
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942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Libro Electrónico
Existencias
Estado de retiro Colección Ubicación permanente Ubicación actual Fecha de ingreso Total Checkouts Date last seen Número de copia Tipo de material
  Colección de Libros Electrónicos Biblioteca Electrónica Biblioteca Electrónica 07/02/2024   07/02/2024 1 Libro Electrónico

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