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3 results on '"Litwin, Jeffrey S."'

1. Cardiac safety: beyond QT: how does ECG reading in clinical research compare to a healthcare interpretation?

Author

Litwin, Jeffrey S.

Subjects
United States. Food and Drug Administration -- Powers and duties, Electrocardiography -- Safety and security measures, Clinical trials -- Safety and security measures, Electrocardiogram -- Safety and security measures, General interest, Health
Abstract

If you talk to a clinical cardiologist about cardiac safety, it is highly unlikely that the letters 'QT' will ever be uttered. On the other hand, if you speak to [...]

Published
2010

2. The science of cardiac safety: centralized approach for Phase III studies enhances the quality and integrity of collected data

Author

Turner, J. Rick, Satin, Lawrence Z., Callahan, Timothy S., and Litwin, Jeffrey S.

Subjects
United States. Food and Drug Administration -- Powers and duties, Clinical trials -- Safety and security measures, Health risk assessment -- Methods, Pharmaceutical industry -- Product development -- Quality management, General interest, Health
Abstract

There is considerable interest in drug safety among multiple stakeholders in the United States, including the Food and Drug Administration (FDA), the National Institutes of Health, the Institute of Medicine [...]

Published
2010

3. The merits of ECG centralization: a call to sponsors to rethink the role of ECGs in drug development and the use of central core labs

Author

Litwin, Jeffrey S.

Subjects
Electrocardiography -- Usage, Electrocardiography -- Analysis, Pharmaceutical industry -- Safety and security measures, Pharmaceutical industry -- Management, Medical laboratories -- Safety and security measures, Medical laboratories -- Management, Electrocardiogram -- Usage, Electrocardiogram -- Analysis, Company business management, General interest, Health
Abstract

[ILLUSTRATION OMITTED] Cardiac safety has become the number one reason for drug withdrawals and labeling changes during the past several years. This has resulted in greater regulatory scrutiny for all [...]

Published
2008

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