Articles

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Research Article
Deconstructing the Drug Development Process: The New Face of Innovation
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
10/12/2010
Research Article
Anticipating Structural Change in the CRO Market
Contract Pharma
Kenneth Getz
10/8/2010
Research Article
Impact of the New US Health-Care-Reform Legislation on the Pharmaceutical Industry: Who Are the Real Winners?
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
9/22/2010
Commentary
Explaining the Drug Drought
Pharmaceutical Executive
Kenneth Kaitin
9/1/2010
Research Article
Drug Development Costs When Financial Risk is Measured Using the Fama-French Three-Factor Model
Health Economics
Joseph DiMasi
7/12/2010
Commentary
The Landscape for Pharmaceutical Innovation: Drivers of Cost-Effective Clinical Research
Pharm Outsourcing
Kenneth Kaitin
5/1/2010
Research Article
Deconstructing the Drug Development Process: The New Face of Innovation
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
2/3/2010
Research Article
Trends in Risks Associated with New Drug Development: Success Rates for Investigational Drugs
Clinical Pharmacology & Therapeutics
Joseph DiMasi
2/3/2010
Commentary
Private Sector Contributions to Pharmaceutical Science: Thirty-Five Summary Case Histories
American Journal of Therapeutics
Joseph DiMasi
1/1/2010
Research Article
Factors Associated with Multiple FDA Review Cycles and Approval Phase Times
Drug Information Journal
Joseph DiMasi
12/30/2009
Commentary
Drug Development Shifts to Small-Scale, Focused Targets
Mass High Tech (MHT)
Kenneth Kaitin
12/16/2009
Commentary
Translational Medicine: An Engine of Change for Bringing New Technology to Community Health
Science Translational Medicine
Kenneth Kaitin
11/9/2009
Research Article
Drug Development Portfolio and Spending Practices after Mergers and Acquisitions
Therapeutic Innovation & Regulatory Science
Joseph DiMasi, Kenneth Kaitin, Kenneth Getz
7/1/2009
Research Article
Successful Outsourcing: Tracking Global CRO Usage
Applied Clinical Trials
Kenneth Getz
6/1/2009
Research Article
Subjects' View of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results from the Experiences of Participants in Clinical Trials (EPIC) Study
Journal of Medical Ethics
Kenneth Getz
3/1/2009
Research Article
Assessing the Impact of Protocol Design Changes on Clinical Trial Performance
American Journal of Therapeutics
Kenneth Kaitin, Kenneth Getz
9/1/2008
Research Article
The Truth About Drug Innovation: Thirty-Five Summary Case Histories on Private Sector Contributions to Pharmaceutical Science
Manhattan Institute for Policy Research
Joseph DiMasi
6/1/2008
Commentary
Misleading Congress About Drug Development: Reply
"Journal of Health Politics, Policy and Law"
Joseph DiMasi
4/1/2008
Book Chapter
Investigator/Institution
Wiley Encyclopedia of Clinical Trials
Kenneth Getz
3/14/2008
Research Article
Assessing the Performance of the EMEA's Centralized Procedure: A Comparative Analysis with the US FDA
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
1/1/2008
Commentary
Follow On Drugs and Indications: the Importance of Incremental Innovation to Medical Practice
American Journal of Therapeutics
Kenneth Kaitin
1/1/2008
Research Article
Racial Disparities Among Clinical Research Investigators
American Journal of Therapeutics
Kenneth Getz
1/1/2008
Commentary
Offshoring: Cost-Effective Clinical Research
Pharma Focus Asia
Kenneth Kaitin
1/1/2008
Research Article
Obstacles and Opportunities in New Drug Development
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
12/19/2007
Commentary
Should the Patent System for New Medicines Be Abolished?
Clinical Pharmacology & Therapeutics
Joseph DiMasi
9/26/2007
Research Article
Global Clinical Trials Activity in the Details
Applied Clinical Trials
Kenneth Getz
9/1/2007
Research Article
The Cost of Biopharmaceutical R&D: Is Biotech Different?
Managerial and Decision Economics
Joseph DiMasi
8/17/2007
Commentary
Commentary [on Scherer (2007), Berndt et al (2007), and Reiffen and Ward (2007)]
Managerial and Decision Economics
Joseph DiMasi
6/1/2007
Commentary
Mandatory Comparator Trials for Therapeutically Similar Drugs: An Assessment of the Facts
American Journal of Therapeutics
Kenneth Kaitin, Joseph DiMasi
5/1/2007
Research Article
CRO Shifts in the Outsourcing Market
Applied Clinical Trials
Kenneth Getz
5/1/2007
Research Article
Determining the Costs of Institutional Review Boards
IRB: Ethics & Human Research
Kenneth Getz
3/1/2007
Research Article
Economics of New Oncology Drug Development
Journal of Clinical Oncology
Joseph DiMasi
1/10/2007
Commentary
Just Another Day at the Office?
The Scientist
Kenneth Kaitin
12/1/2006
Research Article
Variability in the Costs of Institutional Review Board Oversight
Academic Medicine
Kenneth Getz
8/1/2006
Book Chapter
Public and Patient Usage and Expectations for Clinical Trial Registries
Clinical Trial Registries
Kenneth Getz
1/1/2006
Commentary
Down the Critical Path: Who Should Lead?
Applied Clinical Trials
Kenneth Kaitin
8/1/2005
Letter from the Editor
Letter from the Editor
Contemporary Clinical Trials
Kenneth Getz
8/1/2005
Research Article
Cooperative Research Ethics Review Boards: A Win-Win Solution?
IRB: Ethics & Human Research
Kenneth Getz
5/1/2005
Research Article
The Cost of Institutional Review Boards in Academic Medical Centers
The New England Journal of Medicine
Kenneth Getz
4/28/2005
Research Article
Setting the Record Straight: Response to the Light and Warburton Rejoinder
Joseph DiMasi
1/1/2005
Research Article
The Regulation and Approval of New Drugs in China
Drug Information Journal
Kenneth Kaitin
12/30/2004
Report
Assessing Claims About the Cost of New Drug Development: A Critique of the Public Citizen and TB Alliance Reports
Journal of Health Economics
Joseph DiMasi
11/1/2004
Commentary
Looking Back, Looking Forward
Drug Information Journal
Kenneth Kaitin
10/1/2004
Research Article
Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals
Annals of Internal Medicine
Kenneth Getz
8/17/2004
Research Article
R&D Costs and Returns by Therapeutic Category
Drug Information Journal
Joseph DiMasi
7/1/2004
Commentary
Patents and R&D Incentives: Comments on the Hubbard and Love Trade Framework for Financing Pharmaceutical R&D
"W.H.O. Commision on Intellectual Property Rights, Innovation, and Public Health (CIPIH)"
Joseph DiMasi
6/25/2004
Research Article
Going Global
Applied Clinical Trials
Mary Jo Lamberti
6/1/2004
Research Article
The Economics of Follow-On Drug Research and Development
Pharmacoeconomics
Joseph DiMasi
1/1/2004
Research Article
The New Drug Approvals of 1999, 2000, and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
10/1/2003
Research Article
Canadian and US Drug Approval Times and Safety Considerations
Annals of Pharmacotherapy
Kenneth Kaitin
10/1/2003