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S 70
Software innovations in clinical drug development and safety / / Partha Chakraborty and Amit Nagal, editors. - Hershey, PA : : Medical Information Science Reference,, ©2016. - 1 online resource. - (Advances in medical technologies and clinical practice book series). - Includes bibliographical references and index. - URL: https://library.dvfu.ru/lib/document/SK_ELIB/C5D32047-0885-4E9C-AC73-7B006A7CF3B8. - ISBN 9781466687271 (electronic bk.). - ISBN 1466687274 (electronic bk.). - ISBN 1466687266 (hardcover). - ISBN 9781466687264 (hardcover)
Online resource; title from PDF title page (EBSCO, viewed October 7, 2015).
Параллельные издания: Print version: : Software innovations in clinical drug development and safety. - Hershey, PA : Medical Information Science Reference, [2016]. - ISBN 9781466687264
Содержание:
Overview of clinical trial and pharmacovigilance process and areas of application of computer system / Sowmyanarayan Srinivasan -- Innovative means and mechanisms of utilizing optimal clinical and safety aligned data structures -- Application of metadata repository and master data management in clinical trial and drug safety / Chandrakant Ekkirala -- Semantic integration, text mining, tools and technologies / Chandrakant Ekkirala -- Safety signal detection in the drug development process : safety signal detection in the drug development / Ramin B. Arani, Antoni F.Z. Wisniewski -- Application of SMAC technology / Manu Venugopal -- Architecture of an integrated collaboration portal for clinical trial a case study / Partha Chakraborty -- Architecture of an integrated regulatory information management platform for clinical trials : a case study in regulatory information management system implementation / Ayan Choudhury -- Personal diagnostics using DNA-sequencing / Udayaraja G.K. -- Pharmacogenomics genome wide association clinical studies / Udayaraja G.K. -- Role of epigenetic in cancer genomics / Amit Nagal -- Impact of human exome sequencing on clinical research / Anu Acharya, Shibichakravarthy Kannan, Brajendra Kumar, Jasmine Khurana, Sushma Patil, Geethanjali Tanikella -- Computer system validation in life sciences industry / Arindam Dey -- Agile methodology of development and how to be compliant / Yerramalli Subramaniam.
~РУБ DDC 615.10285
Рубрики: Pharmacy informatics.
Drug development.
Genomics.
Drug Discovery
Software
Clinical Trials as Topic
Pharmacovigilance
Genomics
Pharmacie--Informatique.
Médicaments--Développement.
Logiciels.
Pharmacovigilance.
Génomique.
software.
MEDICAL--Pharmacology.
Drug development.
Pharmacy informatics.
Аннотация: "This book is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing"--Provided by publisher.
Доп.точки доступа:
Chakraborty, Partha, (1972-) \editor.\
Nagal, Amit, (1979-) \editor.\
S 70
Software innovations in clinical drug development and safety / / Partha Chakraborty and Amit Nagal, editors. - Hershey, PA : : Medical Information Science Reference,, ©2016. - 1 online resource. - (Advances in medical technologies and clinical practice book series). - Includes bibliographical references and index. - URL: https://library.dvfu.ru/lib/document/SK_ELIB/C5D32047-0885-4E9C-AC73-7B006A7CF3B8. - ISBN 9781466687271 (electronic bk.). - ISBN 1466687274 (electronic bk.). - ISBN 1466687266 (hardcover). - ISBN 9781466687264 (hardcover)
Online resource; title from PDF title page (EBSCO, viewed October 7, 2015).
Параллельные издания: Print version: : Software innovations in clinical drug development and safety. - Hershey, PA : Medical Information Science Reference, [2016]. - ISBN 9781466687264
Содержание:
Overview of clinical trial and pharmacovigilance process and areas of application of computer system / Sowmyanarayan Srinivasan -- Innovative means and mechanisms of utilizing optimal clinical and safety aligned data structures -- Application of metadata repository and master data management in clinical trial and drug safety / Chandrakant Ekkirala -- Semantic integration, text mining, tools and technologies / Chandrakant Ekkirala -- Safety signal detection in the drug development process : safety signal detection in the drug development / Ramin B. Arani, Antoni F.Z. Wisniewski -- Application of SMAC technology / Manu Venugopal -- Architecture of an integrated collaboration portal for clinical trial a case study / Partha Chakraborty -- Architecture of an integrated regulatory information management platform for clinical trials : a case study in regulatory information management system implementation / Ayan Choudhury -- Personal diagnostics using DNA-sequencing / Udayaraja G.K. -- Pharmacogenomics genome wide association clinical studies / Udayaraja G.K. -- Role of epigenetic in cancer genomics / Amit Nagal -- Impact of human exome sequencing on clinical research / Anu Acharya, Shibichakravarthy Kannan, Brajendra Kumar, Jasmine Khurana, Sushma Patil, Geethanjali Tanikella -- Computer system validation in life sciences industry / Arindam Dey -- Agile methodology of development and how to be compliant / Yerramalli Subramaniam.
Рубрики: Pharmacy informatics.
Drug development.
Genomics.
Drug Discovery
Software
Clinical Trials as Topic
Pharmacovigilance
Genomics
Pharmacie--Informatique.
Médicaments--Développement.
Logiciels.
Pharmacovigilance.
Génomique.
software.
MEDICAL--Pharmacology.
Drug development.
Pharmacy informatics.
Аннотация: "This book is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing"--Provided by publisher.
Доп.точки доступа:
Chakraborty, Partha, (1972-) \editor.\
Nagal, Amit, (1979-) \editor.\
2.
Подробнее
K 46
Kinch, Michael, (1966-).
A prescription for change : : the looming crisis in drug development / / Michael S. Kinch. - Chapel Hill : : The University of North Carolina Press,, 2016. - 1 online resource (xi, 339 pages). - (The Luther H. Hodges Jr. and Luther H. Hodges Sr. series on business, entrepreneurship, and public policy). - Includes bibliographical references and index. - URL: https://library.dvfu.ru/lib/document/SK_ELIB/47D5D659-9ED7-4DE6-91A4-7A05D9FC2ECC. - ISBN 1469630648 (electronic bk.). - ISBN 9781469630649 (electronic bk.)
Print version record.
Параллельные издания: Print version: : Kinch, Michael S. Prescription for change. - Chapel Hill : University of North Carolina Press, [2016]. - ISBN 9781469630625
Содержание:
Introduction: How Did We Reach This Point? -- Why Regulate Medicines? -- Trials and Tribulations -- Dreams of Greatness: The Birth of the Pharmaceutical Industry -- Triumph and Tragedy -- Ivory Tower of Power -- The DNA of Biotechnology -- Blockbusters and Bombs: Pressures on the Pharmaceutical Industry -- Sea Monsters, Immunauts, and Death Panels -- Drama on the I-270 Tech Corridor -- Autophagy -- Three Views of a Train Wreck -- Bridging the Valley.
~РУБ DDC 615.1/9
Рубрики: Drug development.
Drugs--Research--Economic aspects.
Pharmaceutical industry.
Drugs--Design.
Drug Design
Drug Industry
Médicaments--Développement.
Médicaments--Recherche--Aspect économique.
Industrie pharmaceutique.
Médicaments--Conception.
MEDICAL--Pharmacology.
BUSINESS & ECONOMICS--Development--Business Development.
Drug development.
Drugs--Research--Economic aspects.
Pharmaceutical industry.
Аннотация: The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes -- and indeed because of them -- our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy. To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come. - Publisher.
K 46
Kinch, Michael, (1966-).
A prescription for change : : the looming crisis in drug development / / Michael S. Kinch. - Chapel Hill : : The University of North Carolina Press,, 2016. - 1 online resource (xi, 339 pages). - (The Luther H. Hodges Jr. and Luther H. Hodges Sr. series on business, entrepreneurship, and public policy). - Includes bibliographical references and index. - URL: https://library.dvfu.ru/lib/document/SK_ELIB/47D5D659-9ED7-4DE6-91A4-7A05D9FC2ECC. - ISBN 1469630648 (electronic bk.). - ISBN 9781469630649 (electronic bk.)
Print version record.
Параллельные издания: Print version: : Kinch, Michael S. Prescription for change. - Chapel Hill : University of North Carolina Press, [2016]. - ISBN 9781469630625
Содержание:
Introduction: How Did We Reach This Point? -- Why Regulate Medicines? -- Trials and Tribulations -- Dreams of Greatness: The Birth of the Pharmaceutical Industry -- Triumph and Tragedy -- Ivory Tower of Power -- The DNA of Biotechnology -- Blockbusters and Bombs: Pressures on the Pharmaceutical Industry -- Sea Monsters, Immunauts, and Death Panels -- Drama on the I-270 Tech Corridor -- Autophagy -- Three Views of a Train Wreck -- Bridging the Valley.
Рубрики: Drug development.
Drugs--Research--Economic aspects.
Pharmaceutical industry.
Drugs--Design.
Drug Design
Drug Industry
Médicaments--Développement.
Médicaments--Recherche--Aspect économique.
Industrie pharmaceutique.
Médicaments--Conception.
MEDICAL--Pharmacology.
BUSINESS & ECONOMICS--Development--Business Development.
Drug development.
Drugs--Research--Economic aspects.
Pharmaceutical industry.
Аннотация: The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes -- and indeed because of them -- our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy. To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come. - Publisher.
Page 1, Results: 2