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Results for: Hear From the Experts - High-quality studies
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The Contribution of Early-phase Clinical Data to a Drug’s Integrated Cardiac Safety Portfolio
January 16, 2012
This article examines the financial and time benefits to incorporating intensive ECG and QT/QTc monitoring in early-phase clinical studies. -
The Contribution of Early-phase Clinical Data to a Drug’s Integrated Cardiac Safety Portfolio
December 6, 2011
This article examines the financial and time benefits to incorporating intensive ECG and QT/QTc monitoring in early-phase clinical studies. -
Dr. Frank Massam
May 13, 2011
Dr. Frank Massam discusses the significance of Quintiles' partnership with Population Genetics Technologies Ltd. -
The US Approval Pathway for Biosimilar Products
February 22, 2011
The Public Health Service Act allows biosimilars in the US. The law incorporates a specific subsection dealing with biosimilars entitled the Biologics Price Competition and Innovation Act of 2009 (BPCIA). -
The Patient is Waiting - Quality's Quiet Impact on the Public Trust - Risky Business, Chapter 8
February 2, 2011
Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter eight carefully steps into the controversies surrounding the public’s expectations about the affordability, effectiveness and safety of prescription drugs. -
25 Years of Regulation - and Still Failing - Risky Business, Chapter 4
February 2, 2011
Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter four identifies two simple principles needed for the improvement of quality management in pharmaceuticals today: managing consistency and maintaining responsiveness. -
Pharmaceutical Quality Control - Taking Comfort in Numbers - Risky Business, Chapter 3
February 2, 2011
Chapter Three Excerpt from Risky Business: Managing the Quality of America’s Medicines by Robert A. Rhoades -
Strange Bedfellows - Science, Business, Politics, and the Law - Risky Business, Chapter 2
February 2, 2011
Chapter Two Excerpt from Risky Business: Managing the Quality of America’s Medicines by Robert A. Rhoades -
Regulatory Landscapes for Future Antidiabetic Drug Development
May 12, 2010
In the March 2010 Journal for Clinical Studies, Dr. Erica Caveney and Dr. Rick Turner analyze the EMA Guidance on diabetes drugs and cardiovascular risk. -
Early phase strategies
June 15, 2009
Web cast about Early Phase Strategies.
