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SPIRES-BOOKS: FIND KEYWORD PHARMACEUTICAL SCIENCES/TECHNOLOGY *END*INIT* use /tmp/qspiwww.webspi1/12900.112 QRY 131.225.70.96 . find keyword pharmaceutical sciences/technology ( in books using www Cover
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Call number:9783319501864:ONLINE Show nearby items on shelf
Title:Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
Author(s): Richard K Burdick
Date:2017
Size:1 online resource (XI, 379 p. 113 illus., 80 illus. in color p.)
Contents:Chapter 1. Introduction -- Chapter 2. Statistical Methods for CMC Applications -- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance -- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation
Guidance -- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance -- Chapter 6. Analytical Procedures -- Chapter 7. Specifications -- Chapter 8. Stability -- Chapter 9. Analytical
Comparability and Similarity
ISBN:9783319501864
Series:eBooks
Series:Springer eBooks
Series:Springer 2017 package
Keywords: Pharmacy , Statistics , Pharmaceutical technology , Statistics , Statistics for Life Sciences, Medicine, Health Sciences , Pharmaceutical Sciences/Technology , Pharmacy
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Call number:SPRINGER-2016-9783319325620:ONLINE Show nearby items on shelf
Title:Group Sequential and Confirmatory Adaptive Designs in Clinical Trials
Author(s): Gernot Wassmer
Date:2016
Size:1 online resource (301 p.)
Note:10.1007/978-3-319-32562-0
Contents:Part I Group Sequential Designs -- Repeated Significance Tests: Procedures with Equally Sized Stages -- Procedures with Unequally Sized Stages -- Confidence Intervals, p -Values, and Point Estimation -- Applications -- Part II Adaptive Confirmatory Designs with a Single Hypothesis: Adaptive Group Sequential Tests -- Decision Tools for Adaptive Designs -- Estimation and p-Values for Two-stage Adaptive Designs -- Adaptive Designs with Survival Data -- Part III Adaptive Designs with Multiple Hypothese s: Multiple Testing in Adaptive Designs -- Applications and Case Studies -- Appendix - Software for Adaptive Designs -- Index
ISBN:9783319325620
Series:eBooks
Series:SpringerLink (Online service)
Series:Springer eBooks
Keywords: Statistics , Pharmaceutical technology , Pharmacy , Biostatistics , Statistics , Statistics for Life Sciences, Medicine, Health Sciences , Biostatistics , Drug Safety and Pharmacovigilance , Pharmaceutical Sciences/Technology
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Call number:SPRINGER-2012-9781461433958:ONLINE Show nearby items on shelf
Title:Space Pharmacology [electronic resource]
Author(s): Virginia E. Wotring
Date:2012
Publisher:Springer US
Size:1 online resource
Note:Brief
Note:Springer 2012 Physics and Astronomy eBook collection
Note:Springer e-book platform
ISBN:9781461433958
Series:SpringerBriefs in Space Development
Series:e-books
Keywords: Extraterrestrial Physics, Space Sciences , Pharmaceutical Sciences/Technology , Inorganic Chemistry
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Call number:SPRINGER-2011-9783642179464:ONLINE Show nearby items on shelf
Title:Modeling Multi-Level Systems [electronic resource]
Author(s): Octavian Iordache
Date:2011
Publisher:Berlin, Heidelberg : Springer Berlin Heidelberg
Size:1 online resource
Note:Springer e-book platform
Note:Springer 2013 e-book collections
Note:This book is devoted to modeling of multi-level complex systems, a challenging domain for engineers, researchers and entrepreneurs, confronted with the transition from learning and adaptability to evolvability and autonomy fortechnologies, devices an d problem solving methods. Chapter 1 introduces the multi-scale and multi-level systems and highlights their presence in different domains of science and technology. Methodologies as, random systems,non-Archimedean analysis, category theory and specific t echniques as model categorification and integrative closure, are presented in chapter 2. Chapters 3 and 4 describe polystochastic models, PSM, and their developments. Categoricalformulation of integrative closure offers the general PSM framework which ser ves as a flexible guideline for a large variety of multi-level modeling problems. Focusing on chemical engineering, pharmaceutical and environmental casestudies, the chapters 5 to 8 analyze mixing, turbulent dispersion and entropy production for multi-sca le systems. Taking inspiration from systems sciences, chapters 9 to 11 highlight multi-level modeling potentialities in formalconcept analysis, existential graphs and evolvable designs of experiments. Case studies refer to separation flow-sheets, pharmace utical pipeline, drug design and development, reliability management systems, security and failureanalysis. Perspectives and integrative points of view are discussed in chapter 12. Autonomous and viable systems, multi-agents, organic and autonomic computi ng, multi-level informational systems, are revealed as promising domains forfuture applications. Written for: engineers, researchers, entrepreneurs and students in chemical, pharmaceutical, environmental and systems sciences engineering, and for applied m athematicians
Note:Springer eBooks
Contents:Introduction
Methodological Resources
Conventional PSM frames
New PSM frames
Mixing in chemical reactors
Compartmental systems
Turbulent mixing
Entropy
Formal concept analysis
Existential graphs
Evolvable designs of experiments
Autonomous systems perspective
ISBN:9783642179464
Series:e-books
Series:SpringerLink (Online service)
Series:Understanding Complex Systems, 1860-0832 : v70
Series:Physics and Astronomy (Springer-11651)
Keywords: Engineering
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Call number:SPRINGER-2011-9781441998422:ONLINE Show nearby items on shelf
Title:Modern Issues and Methods in Biostatistics [electronic resource]
Author(s): Mark Chang
Date:2011
Publisher:New York, NY : Springer New York
Size:1 online resource
Note:Springer e-book platform
Note:Springer 2013 e-book collections
Note:Classic biostatistics, a branch of statistical science, has as its main focus the applications of statistics in public health, the life sciences, and the pharmaceutical industry. Modern biostatistics, beyond just a simpleapplication of statistics, is a confluence of statistics and knowledge of multiple intertwined fields. The application demands, the advancements in computer technology, and the rapid growth of life science data (e.g., genomics data)have promoted the formation of modern biostatistics. There are at least three characteristics of modern biostatistics: (1) in-depth engagement in the application fields that require penetration of knowledge across several fields, (2)high-level complexity of data because they are longitudinal, incomplete, o r latent because they are heterogeneous due to a mixture of data or experiment types, because of high-dimensionality, which may make meaningful reductionimpossible, or because of extremely small or large size and (3) dynamics, the speed of development in methodology and analyses, has to match the fast growth of data with a constantly changing face. This book is written forresearchers, biostatisticians/statisticians, and scientists who are interested in quantitative analyses. The goal is to introduce moder n methods in biostatistics and help researchers and students quickly grasp key concepts and methods.Many methods can solve the same problem and many problems can be solved by the same method, which becomes apparent when those topics are discussed inthis s ingle volume
Note:Springer eBooks
Contents:Multiple
Hypothesis Testing Strategy
Pharmaceutical Decision and Game Theory
Noninferiority Trial Design
Adaptive Trial Design
Missing Data Imputation and Analysis
Multivariate and Multistage Survival Data Modeling
Meta
analysis
Data Mining and Signal Detection
Monte Carlo Simulation
Bayesian Methods and Applications
ISBN:9781441998422
Series:e-books
Series:SpringerLink (Online service)
Series:Statistics for Biology and Health, 1431-8776
Series:Mathematics and Statistics (Springer-11649)
Keywords: Statistics , Data mining , Mathematics , Engineering
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Call number:SPRINGER-1995-9789401106153:ONLINE Show nearby items on shelf
Title:Advanced LIMS Technology Case Studies and Business Opportunities
Author(s):
Date:1995
Size:1 online resource (247 p.)
Note:10.1007/978-94-011-0615-3
Contents:1 LIMS: An automating or informating technology? -- 1.1 Introduction -- 1.2 Current LIMS fail to meet business requirements -- 1.3 Current LIMS automate data management functions -- 1.4 New LIMS will informate, not automate -- 1.5
Architecture of an informating system -- 1.6 Making IT happen -- References -- 2 A model for a comprehensive LIMS -- 2.1 Introduction -- 2.2 Strategic design of a LIMS -- 2.3 What is a LIMS? -- 2.4 An architecture for a comprehensive
LIMS -- 2.5 A LIMS model -- 2.6 Definition of a LIMS -- 2.7 Detailed classification of LIMS functions -- 2.8 Applying the LIMS model: the selection of a commercial LIMS -- 2.9 LIMS standards -- 2.10 Summary -- References -- 3 LIMS in a
forensic laboratory -- 3.1 Introduction -- 3.2 Objectives of a LIMS -- 3.3 The system -- 3.4 The future -- 3.5 Conclusions -- Acknowledgement -- 4 Application of a LIMS in a pharmaceutical drug metabolism and pharmacokinetics
laboratory -- 4.1 Introduction -- 4.2 Study objectives in drug metabolism and pharmacokinetics -- 4.3 Configuration of the database -- 4.4 LabManager in use -- 4.5 The future -- References -- 5 Use of protocol-synchronous LIMS
structures to expand the role of the centralized clinical trial laboratory in pharmaceutical research -- 5.1 Introduction -- 5.2 The expanding role of the central laboratory in pharmaceutical research -- 5.3 Comparing traditional and
protocol-synchronous LIMS structures in the clinical trial laboratory -- 5.4 Defining protocol-driven time and events using a multidimensional matrix -- 5.5 Managing protocol-driven time and events using matrix-dependent control
structures -- 5.6 Managing protocol-driven time and events using matrix-dependent output structures -- 5.7 Summary -- 6 Medical Laboratory Information Systems (LIS) -- 6.1 History of clinical laboratory computerization -- 6.2
Computerization and automation of the ‘testing process’ -- 6.3 How computers function in the clinical laboratory -- 6.4 Acquisition of a LIS -- 6.5 Future of laboratory information systems -- References -- 7 EPA’s Relational Laboratory
Information Management System: Development and implementation -- 7.1 Introduction -- 7.2 Development -- 7.3 Implementation -- 7.4 Conclusions -- References -- 8 LIMS to robotics interface: A practical approach -- 8.1 Introduction --
8.2 The case for automation -- 8.3 Role of a Laboratory Information Management System -- 8.4 Sample planning and scheduling -- 8.5 Auditability -- 8.6 Information transferred via the interfaces -- 8.7 Laboratory Information Management
System network -- 8.8 Analytical process automation -- 8.9 Impact on the laboratory working environment -- References -- 9 Interfacing the real world to LIMS -- 9.1 Introduction -- 9.2 The analysis procedure -- 9.3 Beckman -- 9.4
Hewlett Packard -- 9.5 LabSystems (Fisons Instruments) -- 9.6 The future -- Acknowledgements -- 10 Replacement LIMS: Moving forward or maintaining the status quo -- 10.1 Introduction -- 10.2 Why change? -- 10.3 Why not change? -- 10.4
How long should a LIMS last? -- 10.5 How do you justify a replacement LIMS? -- 10.6 Would a custom system be better? -- 10.7 Support your vendor -- 10.8 How to implement a replacement LIMS -- 11 The promise of client—server LIMS
applications -- 11.1 Introduction -- 11.2 Review of LIMS development over the last ten years — the story so far -- 11.3 Current trends -- 11.4 Regulatory requirements -- 11.5 Standards for systems analysis and construction of
information systems -- 11.6 Understanding the user -- 11.7 Meeting the requirements with appropriate technology: The challenge facing client-server technology -- 11.8 Discussion of relationships and issues -- 11.9 Systems analysis,
construction of information systems and process re-engineering -- 11.10 Software development -- 11.11 Communications -- 11.12 Implementing client-server technology -- 11.13 Conclusions -- 11.14 The way forward? -- References -- 12
Standards for analytical laboratory data communications, storage, and archival -- 12.1 Introduction -- 12.2 Standards investment and payback -- 12.3 The ADISS Program -- 12.4 Application of the ADISS Information Model to chromatography
-- 12.5 Future ADISS extensions for chromatography and other techniques -- 12.6 Future influence of ADISS standards on LIMS in R&D -- 12.7 The influence of standards on market dynamics -- 12.8 Summary and recommendations -- Note --
References
ISBN:9789401106153
Series:eBooks
Series:SpringerLink (Online service)
Series:Springer eBooks
Keywords: Statistics , Statistics , Statistics for Life Sciences, Medicine, Health Sciences , Statistics, general
Availability:Click here to see Library holdings or inquire at Circ Desk (x3401)
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