LEADER 06505oam 2200421zu 450 001 996204863303316 005 20210807003500.0 035 $a(CKB)111026746744218 035 $a(SSID)ssj0000558864 035 $a(PQKBManifestationID)12208270 035 $a(PQKBTitleCode)TC0000558864 035 $a(PQKBWorkID)10566059 035 $a(PQKB)10277225 035 $a(NjHacI)99111026746744218 035 $a(EXLCZ)99111026746744218 100 $a20160829d1997 uy 101 0 $aeng 135 $aur||||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aSoftware Technology and Engineering Practice: Proceedings of the 8th International Workshop on Software Technology and Engineering Practice Incorporating Computer Aided Software Engineering, London, 1997 210 31$a[Place of publication not identified]$cIEEE Computer Society Press$d1997 215 $a1 online resource (xix, 500 pages) $cillustrations 300 $aBibliographic Level Mode of Issuance: Monograph 311 $a0-8186-7840-2 327 $aForeword -- Conference and Program Committees -- IWCASE Officers -- About IWCASE -- Workshop Abstracts -- Aligning IT Strategy to Business Need -- Paper Session Pla: System Architectures -- Yasmin: A Component Based Architecture for Software Applications -- An Architecture for Designing Internationalized Software -- Hypernode Model Support for Software Design Methodology Modeling -- Paper Session Plb: Reverse Engineering asd Legacy Systems -- A System for Generating Reverse Engineering Tools -- A Practical System of COBOL Program Reuse for Reengineering -- Support for Modular Parsing in Software Reengineering -- Paper ksion Plc: System Development Methods -- Constructing Formal Specifications from Informal Requirements -- Is My Software Process Improvement Suitable for Incremental Deployment? -- Product Development a Chunk at a Time -- Paper Session ma: Measurement and Ikktries -- A Process for Asynchronous Software Inspection -- GQM-Based Improvement of Embedded, Real-Time Software Development Practices -- An Estimated Method for Software Testability Measurement -- Paper Session P2b: Experiences with 00 Development -- An Object-Oriented Framework for Transaction Capture Using Co-operating Business Rule Components -- An Experience in Deploying Object-Orientation for Business Applications -- Experiences with Object Oriented Model-Driven Development -- Paper Session P2c: Project Management Tools -- Project Performance Indicator Workbench (PPIW) -- A Methodical Approach to Establishing a Process Management Infrastructure in an Organization -- Supporting Impact Analysis and Change Propagation in Software Engineering Environments -- Paper Session P3a: Quality Issues -- User-Perceptions of Embedded Software Quality -- Extending the AMI Approach to Encompass the Foundation Activity -- Promoting the Software Design for Testability Towards a Partial Test Oracle -- Paper Session P3b: Experiences with 00 Development I1 -- An Object Oriented Petri Net Language for Embedded System Design -- Object-Oriented Requirements Analysis for Air Traffic Control Systems -- An Overview of Object-Oriented Design Metrics -- Paper Session P3c: Configuration Management and System Interconnection Tools -- Software Configuration Management Tools -- An Experience in Setting-Up a Configuration Management Environment -- Stevens Lecture on Software Developaient Methods -- The Place and Value of Method in Software Development -- Keynote 2 Computing Trends New Software Concepts: Are Any of Them Really Breakthroughs? -- Paper Session P4a: CASE -- CASE in the 21 st Century: Challenges Facing Existing CASE Vendors. -- On the Scope of Relationships -- Ahead-of-Time Debugging, Or Programming Not in the Dark -- Paper Session P4b: Software Reuse, Patterns and Architecture -- Reusable Project-Specific Software for Industrial Control -- A Software Engineering Environment for Configuring Distributed Applications from Reusable Software Architectures -- Reengineering Legacy Applications Using Design Patterns -- Understanding Resistance to Software Reuse -- Paper Session P4c: Process Modeling -- End User Computing: How an Organization can Maximize Potential -- Balancing Acts: Reconciling Competing Visions of the Way Software Technologists Work -- BOOTSTRAP: Five Years of Assessment Experience -- Paper Session P4d: Software EngineeringEducation -- Systems Development with Java: Experiences from a Practical Project Course in Software Engineering -- A Course in Software Engineering and Project Management at University Level for Industrial Needs Some Reliable Results After Ten Years of Experiences -- Paper Session P5a; System Development Methods II -- Software Technology for Embedded Systems -- Software Engineering Support for Reliably Interconnecting Legacy Virtual Environments -- Managing the Human-Software Environment -- Paper Session P5b: Employing COTS Technology -- The SYNTHESIS Environment for Component-Based Software Development -- Feature Modeling of Component-Based Embedded Software -- Component-Based Systems Development: Challenges and Lessons Learned -- Paper Session I'5c: Requirements Specification -- Getting the Requirements Right - A Professional Approach -- Developing Component-Based Tools for Requirements Reuse: A Process Guide -- Terminologies and Terminology Servers for Information Environments -- Author Index. 330 $aProceedings of the July 1997 workshop, concentrating on software engineering's role in software and systems development, evolution, and management. Reports on current practical, applied, experimental, and theoretical work affecting software engineering practice, with sections on system architectures, reverse engineering, system development methods, OO development, configuration management and system interconnection tools, software reuse, process modeling, software engineering education, and COTS technology. No index. Annotation copyrighted by Book News, Inc., Portland, OR. 606 $aSoftware engineering$vCongresses 615 0$aSoftware engineering 676 $a005.1 700 $aBudgen$b D$0546279 702 $aBudgen$b David 801 0$bPQKB 906 $aBOOK 912 $a996204863303316 996 $aSoftware Technology and Engineering Practice: Proceedings of the 8th International Workshop on Software Technology and Engineering Practice Incorporating Computer Aided Software Engineering, London, 1997$92346163 997 $aUNISA LEADER 04592nam 22007335 450 001 9910983317403321 005 20250905104422.0 010 $a9783031671104 010 $a3031671104 024 7 $a10.1007/978-3-031-67110-4 035 $a(CKB)36431113800041 035 $a(DE-He213)978-3-031-67110-4 035 $a(MiAaPQ)EBC31743898 035 $a(Au-PeEL)EBL31743898 035 $a(OCoLC)1492952662 035 $a(EXLCZ)9936431113800041 100 $a20241028d2025 u| 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aDose Finding and Beyond in Biopharmaceutical Development /$fedited by Jingjing Ye, Ding-Geng Chen, Wen Zhou, Qiqi Deng, Joseph C. Cappelleri 205 $a1st ed. 2025. 210 1$aCham :$cSpringer Nature Switzerland :$cImprint: Springer,$d2025. 215 $a1 online resource (XVII, 254 p. 43 illus.) 225 1 $aICSA Book Series in Statistics,$x2199-0999 311 08$a9783031671098 311 08$a3031671090 327 $aEmerging Topics in Dose-Finding and Beyond -- Understanding FDA Guidance On Dosage Optimization For Oncology Therapies -- FDA Project Optimus: The "Paradigm-Shifting" Initiative for Oncology Drug Development -- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs -- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs -- Monotonic Dose Response Assumption and Curve-Free Designs for Phase I Dose Finding Trials -- Dose Selection with 2-in-1 Design -- A Rank-Based Approach to Improve the Efficiency of Inferential Seamless Phase 2/3 Clinical Trials with Dose Optimization -- Comparing MCP-MOD and Ordinal Linear Contrast Test in Dose Finding Clinical Trials: A Thorough Examination -- Patient-Reported Tolerability in Drug Development -- Endpoint Development and Validation. 330 $aThis book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development. Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase ? clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase ? confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs. The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development. . 410 0$aICSA Book Series in Statistics,$x2199-0999 606 $aBiometry 606 $aExperimental design 606 $aData mining 606 $aBiostatistics 606 $aDesign of Experiments 606 $aData Mining and Knowledge Discovery 606 $aBiometria$2thub 606 $aDisseny d'experiments$2thub 606 $aMineria de dades$2thub 608 $aLlibres electrònics$2thub 615 0$aBiometry. 615 0$aExperimental design. 615 0$aData mining. 615 14$aBiostatistics. 615 24$aDesign of Experiments. 615 24$aData Mining and Knowledge Discovery. 615 7$aBiometria 615 7$aDisseny d'experiments 615 7$aMineria de dades 676 $a570.15195 702 $aYe$b Jingjing$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aChen$b Ding-Geng$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aZhou$b Wen$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aDeng$b Qiqi$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aCappelleri$b Joseph C$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910983317403321 996 $aDose Finding and Beyond in Biopharmaceutical Development$94316181 997 $aUNINA