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Recent Posts
- Improving Your Drug’s Value Proposition throughout the Product Lifecycle: How Optimized Clinical Outcomes Assessment (COA) Strategies Can Drive Commercialization Success
- Metrics Champion Consortium – Cardiopulmonary Performance Metrics Initiative
- The Importance of Inspiratory Capacity in COPD Clinical Trials
- CLEAR Study Update: A look inside the collaboration between ERT and UCLA
- Brief Report – Changes to the FDA Draft Guidance Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials
Archives
Category Archives: FDA
Cardiac Safety in Obesity Drugs – FDA Advisory Committee
Written by: Dr. Robert Kleiman, Chief Medical Officer & Vice President, Global Cardiology Obesity is one of the nation’s largest health problems and has grown into a major epidemic. Over the past 20 years, obesity rates in the US have continued … Continue reading
Evaluation of the effect on Cardiac Repolarization (QTc Interval) of Cytotoxic Oncologic Drugs
Information Provided by Dr. Robert Kleiman, Chief Medical Officer & Vice President, Global Cardiology During the development of oncologic agents, there are many cardiovascular toxicities to consider. Oncologic agents may produce direct cardiac contractile depression, myocardial ischemia, alterations in blood pressure, myocarditis, cardiac tamponade, … Continue reading
Posted in Cardiac Safety, Clinical Research, Clinical Trials, FDA, Oncology
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ePRO Seminar Series: Bringing Scientific Experts Direct to Your Location.
We are pleased to announce an upcoming seminar series for ePRO beginning this September! The collection of patient self-reported data is becoming increasingly important and, in some cases, a regulatory requirement in the assessment of safety and efficacy, and to … Continue reading
Spirometry Basics and Centralization
Approximately 15% of the world‘s population suffer from Respiratory diseases such as Asthma, COPD or others. Most Respiratory Diseases are classified as either obstructive, which are an inflammatory condition of the airway, or restrictive, which are characterized by reduced total lung … Continue reading
The Diabetes Pandemic: Responding to FDA Guidance on Cardiovascular Risk in Type 2 Diabetes Treatment with Cardiologist, Dr. Robert Kleiman.
Welcome back! This information has been provided by board-certified cardiologist, Dr. Robert Kleiman. Each of you reading today most likely knows someone who is personally affected by Diabetes, as Diabetes is increasing at a disturbing rate in the US, Europe and … Continue reading
Posted in Cardiac Safety, Clinical Research, FDA, Pharmaceutical
Tagged cardiac safety, clinical research, FDA Guidance, pharmaceutical
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