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Medical Device Recalls and the FDA Approval Process
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Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization
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The future is now: Model-based clinical trial design for Alzheimer's disease
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The effectiveness of contractual and trust-based governance in strategic alliances under behavioral and environmental uncertainty
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January 2016 |
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Exploration and exploitation alliances in biotechnology: a system of new product development
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January 2004 |
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Predictors of orphan drug approval in the European Union
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January 2008 |
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Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop
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October 2014 |
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Underinvestment in Public Good Technologies
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December 2004 |
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Expertise, Regulatory Science and the Evaluation of Technology and Risk: Introduction to the Special Issue
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May 2017 |
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Regulatory uncertainty and the associated business risk for emerging technologies
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March 2011 |
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Nanotechnology in the marketplace: how the nanotechnology industry views risk
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April 2013 |
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Multi-level perspectives with technology readiness measures for aviation innovation
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September 2012 |
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Technical change in the commercial aircraft industry, 1925–1975
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December 1981 |
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Strategic alliances and internationalisation in the aircraft manufacturing industry
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June 2004 |
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Technology spillover as a complement for high-level R&D intensity in the pharmaceutical industry
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April 2002 |
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On audits and airplanes: Redundancy and reliability-assessment in high technologies
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May 2011 |
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Accelerating the development and diffusion of new energy technologies: Beyond the “valley of death”
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July 2011 |
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Analysing the economic impact of the new renewable electricity support scheme on solar PV plants in Spain
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March 2018 |
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Drugs, Devices, and the FDA: Part 1
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April 2016 |
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Commercializing generic technology: The case of advanced materials ventures
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April 2006 |
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Intermediation and the role of intermediaries in innovation
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June 2006 |
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Knowledge sources, patent protection, and commercialization of pharmaceutical innovations
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July 2010 |
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Technology policy and global warming: Why new policy models are needed (or why putting new wine in old bottles won’t work)
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October 2010 |
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When risks cannot be seen: Regulating uncertainty in emerging technologies
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September 2017 |
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The tentative governance of emerging science and technology—A conceptual introduction
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June 2019 |
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Implementing technology-forcing policies: The 1970 Clean Air Act Amendments and the introduction of advanced automotive emissions controls in the United States
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September 2005 |
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Planned adaptation in risk regulation: An initial survey of US environmental, health, and safety regulation
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July 2010 |
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Big Pharma, little science?
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January 2014 |
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Radical innovation in scaling up: Boeing’s Dreamliner and the challenge of socio-technical transitions
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January 2016 |
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Constitutions and Commitment: The Evolution of Institutions Governing Public Choice in Seventeenth-Century England
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December 1989 |
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Economic and Environmental Costs of Regulatory Uncertainty for Coal-Fired Power Plants
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January 2009 |
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Translational research: Crossing the valley of death
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June 2008 |
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The Biomarkers Consortium: Practice and Pitfalls of Open-Source Precompetitive Collaboration
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May 2010 |
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The Critical Path Institute’s Approach to Precompetitive Sharing and Advancing Regulatory Science
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May 2010 |
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One year in—Obama's biotech scorecard
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March 2010 |
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Regulatory uncertainty over genome editing
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January 2015 |
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Precision medicine and the changing role of regulatory agencies
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October 2016 |
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Can the pharmaceutical industry reduce attrition rates?
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August 2004 |
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Alzheimer's failure raises questions about disease-modifying strategies
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October 2010 |
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Competitiveness in follow-on drug R&D: a race or imitation?
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December 2010 |
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The Biomarkers Consortium
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October 2014 |
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Drug Development and the FDA's Critical Path Initiative
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January 2007 |
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The Biomarkers Consortium: On the Critical Path of Drug Discovery
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January 2008 |
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Management-Based Regulation: Prescribing Private Management to Achieve Public Goals
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November 2003 |
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Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer
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June 2012 |
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Regulatory Innovation and Drug Development for Early-Stage Alzheimer's Disease
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March 2013 |
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Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
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November 2013 |
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The 21st Century Cures Act — Will It Take Us Back in Time?
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June 2015 |
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The US Aerospace Industry: A Manufacturing Powerhouse
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July 2016 |
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Driving Innovations Across the Valley of Death
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January 2005 |
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Small-Firm Strategic Research Partnerships: The Case of Biotechnology
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June 2003 |
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‘Legitimation’ and ‘development of positive externalities’: two key processes in the formation phase of technological innovation systems
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September 2008 |
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Connecting life science entrepreneurs with resources and expertise: the role ofiungensbrokerage in life science innovation
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December 2015 |
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Technology Infrastructure: Introduction to the Special Issue
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November 2008 |
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Regulating Emerging Technologies
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July 2009 |
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Scaffold engineering: a bridge to where?
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March 2009 |
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Patents, Innovation and Access to New Pharmaceuticals
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December 2002 |
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Regulatory Capture: A Review
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June 2006 |
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Global sourcing: process and design for efficient management
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October 2003 |
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Regulatory issues in blockchain technology
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May 2017 |
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The Role of Public–Private Partnerships in Catalyzing the Critical Path
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July 2017 |
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Regulatory Uncertainty: A Reason to Postpone Investments? Not Necessarily
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November 2009 |
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Trust and technology: the social foundations of aviation regulation
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March 2010 |
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Product-service innovation and performance: the role of collaborative partnerships and R&D intensity
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April 2017 |
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Sustaining the Data and Bioresource Commons
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October 2010 |
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Advancing Regulatory Science
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February 2011 |
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Is Pharma Running Out of Brainy Ideas?
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July 2010 |
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Is the FDA approving drugs too fast?
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October 1998 |
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Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
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Adaptive Governance of Social-Ecological Systems
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November 2005 |
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The FDA Critical Path Initiative and Its Influence on New Drug Development
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February 2008 |
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The Institutional Environment for Telecommunications Investment
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March 2001 |
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When the Chick Hits the Fan
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February 2007 |
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Understanding ‘anticipatory governance’
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November 2013 |
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Maximizing Intra-Agency Relationships through Advanced General Aviation Transport Experiments and Small Aircraft Transportation System
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April 2005 |
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On Public–Private Partnership Performance
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August 2016 |
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Brokerage, Boundary Spanning, and Leadership in Open Innovation Communities
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April 2007 |
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The Decline Of Venture Capital Investment In Early-Stage Life Sciences Poses A Challenge To Continued Innovation
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February 2015 |
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The Predictive Safety Testing Consortium: safety bio-markers, collaboration, and qualification
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November 2016 |
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Characteristics of Organizational Environments and Perceived Environmental Uncertainty
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September 1972 |
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Technology Brokering and Innovation in a Product Development Firm
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December 1997 |
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Regulation and Firm Size: FDA Impacts on Innovation
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January 1990 |
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Building Cooperation in a Competitive Industry: Sematech and the Semiconductor Industry.
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February 1995 |
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Policy Uncertainty and Technological Innovation
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July 1981 |
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Three Types of Perceived Uncertainty about the Environment: State, Effect, and Response Uncertainty
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January 1987 |
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Building Theories from Case Study Research
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October 1989 |
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A Real Options Logic for Initiating Technology Positioning Investments
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October 1997 |
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Regulatory Barriers to the Diffusion of Innovation: Some Evidence from Building Codes
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January 1977 |
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Overcoming “The Valley of Death”
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September 2014 |
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Lessons Learned from the 787 Dreamliner Issue on Lithium-Ion Battery Reliability
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September 2013 |
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On the Regulatory Approval Pathway of Biosimilar Products
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March 2012 |
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Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies
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January 2010 |
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Business groups and their corporate strategies on the Argentine roller coaster of competitive and anti-competitive shocks
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August 2003 |
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From the Editors: What Grounded Theory is Not
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Theory Building From Cases: Opportunities And Challenges
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Methodological fit in management field research
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October 2007 |