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The Resource Accelerated predictive stability (APS) : fundamentals and pharmaceutical industry practices, edited by Fenghe Qiu, Garry Scrivens

Accelerated predictive stability (APS) : fundamentals and pharmaceutical industry practices, edited by Fenghe Qiu, Garry Scrivens

Label
Accelerated predictive stability (APS) : fundamentals and pharmaceutical industry practices
Title
Accelerated predictive stability (APS)
Title remainder
fundamentals and pharmaceutical industry practices
Statement of responsibility
edited by Fenghe Qiu, Garry Scrivens
Contributor
Editor
Subject
Language
eng
Summary
"Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly.Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS)Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studiesCovers up-to-date regulatory experience"--
Member of
Assigning source
Provided by publisher
Cataloging source
N$T
Dewey number
615.1
Index
index present
LC call number
RS424
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/relatedWorkOrContributorName
  • Qiu, Fenghe
  • Scrivens, Garry
http://library.link/vocab/subjectName
  • Drug stability
  • Pharmaceutical industry
  • Prediction theory
Label
Accelerated predictive stability (APS) : fundamentals and pharmaceutical industry practices, edited by Fenghe Qiu, Garry Scrivens
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Extent
1 online resource.
Form of item
online
Isbn
9780128027851
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
System control number
  • on1035845164
  • (OCoLC)1035845164
Label
Accelerated predictive stability (APS) : fundamentals and pharmaceutical industry practices, edited by Fenghe Qiu, Garry Scrivens
Publication
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Extent
1 online resource.
Form of item
online
Isbn
9780128027851
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
System control number
  • on1035845164
  • (OCoLC)1035845164

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