SOURCE: Xtalks

Xtalks Webinars

July 17, 2017 07:30 ET

How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology

In this new webinar hosted by Xtalks, the presenters will share both design and methodology guidance in Non-GLP Toxicology studies in translational models. The session will guide viewers in how to design the most optimal study to provide the greatest opportunity to generate robust, high-quality data, that gives maximum confidence to select new drug candidates and regulatory submissions.

TORONTO, ON--(Marketwired - July 17, 2017) - Peripheral neuropathy affects about 50% of the diabetic population. The manifestations range from pain, numbness, paresthesia and ulceration in the extremities and it is the major cause of non-traumatic amputations. Other than good glycemic control, which is non-effective for subjects with type 2 diabetes, there is no treatment for diabetic peripheral neuropathy. With the prevalence of obesity and type 2 diabetes and associated complications reaching epidemic levels, there is a critical need for finding a treatment to preserve and perhaps restore nerve function.

Prior to clinical studies in humans, an investigational new drug (IND) application must be submitted to the FDA containing, among other things, information on any risks anticipated based on the results of pharmacologic and toxicological data collected during studies of the compound in appropriate models.

The studies, when designed correctly, guide selection of a safe starting dose for humans, provide an understanding of which organs may be the targets of toxicity, estimate the margin of safety between a clinical and a toxic dose, and in some cases, predict pharmacokinetic and pharmacodynamic parameters. These early tests are usually resource intensive, requiring significant investment in product synthesis, animal use, laboratory analyses, and time. Safety pharmacology studies are of special interest, and some drawbacks and pitfalls must be considered (i.e. invasive methods, difficulties related to GLP (good laboratory practices) requirements, choice of a strategy).

Join experts from Crown Bioscience for a live session on Wednesday, July 26, 2017 at 7am EDT (12pm BST/UK) to learn about:

  • How to optimize design of Non-GLP toxicology studies for generating robust, high-quality data
  • What pitfalls to avoid in choosing a design strategy and proper methodology to give maximum confidence in study results

For more information or to register visit: How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology

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