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The Diabetes Series 2008
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WEBINAR SIGNUP To receive updates on diabetes therapeutics provide your email address.
About The Diabetes Series
Many companies are involved in the development of therapeutics and
diagnostics for diabetes and its complications. There are an
innumerable number of possible targets between Type I / Type II
diabetes, and the complications of diabetes. As companies grapple with
the various scientific issues, a smooth pathway to registration must be
navigated. What are the pitfalls in moving very early diabetes
compounds through the IND process? What are some of the issues that
must be considered in designing clinical trials for the different
possible indications? What are the considerations for
registering compounds for the different diabetes therapeutic
indications? These are only some of the questions to be discussed
during The Diabetes Series. We look forward to your participation. Click on any date for more information
Considerations for the Development of Diabetic Therapeutics Dr. Alexander Fleming will provide an overview of diabetes (Type I and Type II), and related illnesses, and complications. Obesity, cardiovascular and vascular complications will be discusssed. Possible targets and implications of studying these will be considered. Nonclinical Models for Diabetic Indications Dr. Bill Hodnick, Ricerca Biosciences *Dr. Gregory Janis, Medtox Considerations for study designs for different diabetic indications will be presented. Considerations for development of bioanalytical methods and validation of these will be presented. Toxicological Evaluation of Diabetic Therapeutics An overview of the GLP toxicological studies that must be conducted for Investigational new Drug Applications and New Drug Applications / Marketing Authorization Applications will be presented. Combination products and diagnostic / device products will also be considered. Clinical Research for Diabetic Therapeutics Dr.John K. Whisnant, Kinexum The metabolic syndrome is a constellation of diseases that includes obesity, insulin resistance and Type II diabetes, high blood pressure and alterations in cholesterol and fat metabolism. This syndrome (also known as Syndrome X) represents one of the largest health threats to the western world today. Treatments for individual components of the syndrome will be very useful in their own right, but also have the potential to influence other facets of this inter-related disease. For example, treatments that reduce obesity should also reduce the risk of developing Type II diabetes. Professor Baxter will use the development of thyroid hormone analogues to illustrate issues and approaches with the development of novel therapeutics for the treatment of the metabolic syndrome. Clinical Development of Diabetic Therapeutics Clinical development considerations for diabetes and the complications of diabetes will be presented. This webinar will include protocol designs for novel therapeutic approaches including transplantation approaches. Registration Strategies for Diabetic Therapeutics and the Complications of Diabetes Dr. Ray Lipicky - Ex FDA* Registation strategies, registration endpoints, considerations for building registration dossiers will be covered for various types of diabetic therapeutics. There will be opportunities for asking specific questions for currently encountered issues in an anonymous format. Stay Informed. Don't miss this opportunity! Click Here >>
WEBINAR SIGNUP To receive updates on diabetes therapeutics provide your email address.
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