Innovative Approaches to Safety Pharmacology

Venue: Philadelphia

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Mar 29, 2004 End Date/Time: Mar 29, 2004
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Description

The definition of Safety Pharmacology (SP) studies, as stated in the ICH S7A Guidelines, are those studies that investigate `the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above', and permits both in vivo and in vitro techniques, as appropriate. The creation of these guidelines and the FDA’s subsequent endorsement and incorporation of them has had a major impact on drug development. The FDA and ICH guidelines provide increased clarity, but along with it comes increased FDA scrutiny of the results.
With the new guidelines serving as a backdrop, the continually evolving environment of pharmacology is providing novel techniques to test new substances, which aid executives managing straining research budgets but also create confusion over the best SP assessment techniques to be endorsed. Many of these techniques require extensive validation periods before the industry and the FDA accept and incorporate them into a development strategy. Understanding how to increase attrition of compounds earlier in the development cycle and provide the necessary information the FDA requires for review are critical toward building a cost-effective SP strategy. It is paramount to attain unequivocal knowledge of the validation techniques to determine their relevance in identifying specific human adverse events, the divergence of these approaches to more traditional studies, and of course, ensuring that the results will be cost-effective, timely and provide usable biomarkers for further development.
Pharmaceutical Education Associates is proud to present the much-anticipated Innovative Approaches to Safety Pharmacology conference, taking place March 29-30, 2004 in Philadelphia, PA. This conference strives to demonstrate the role of new technology-based approaches pharmaceutical executives can incorporate into SP core battery and secondary testing of cardiovascular, respiratory, CNS-neuromuscular, and renal endpoints in animals and human studies.

At this highly progressive conference you benefit from your peers who are successfully employing techniques to solve these issues:
• Timing of safety pharmacology studies: strategic positioning in drug development
• Implementing advanced techniques in assessing pharmacodynamic function
• Setting up and maintaining a GLP Safety Pharmacology laboratory
• Designing a GLP Compliance Statement
• Validating new techniques for understanding and predicting clinical data
• Using more sophisticated proarrhythmia assessments, QT interval duration measurements may be rendered obsolete
• Timing and analyzing the multiple factors that go into the integrated risk assessment for QT interval
• Regulatory (safety) versus business decisions in the preclinical environment
• Recording the EEGs of rodents and analyzing the data in a useful manner to determine if compounds affect global CNS processes
• Inducing colonic hypersensitivity in the rodent model

Sign Up for the Exclusive Pre-Conference Workshop:
Steps to Ensure Good Laboratory Practice in Compliance with 21 CFR Part 11
GLP guidelines define laboratory operational requirements that must be met so that technical data from laboratory studies may be acceptable for reviewing the suitability of a test substance to eventually be administered to humans. Compliance with these regulations is of such high importance that many manufacturers and CROs claim that between 10%-50% of their development effort is expended on quality assurance. Because of this expenditure, it is critical to know how to carefully streamline and incorporate procedures. This workshop, which is facilitated by Richard J. Briscoe, PhD who is the Senior Research Fellow of Safety Pharmacology at Merck & Co Inc, addresses the overall issues required in maintaining GLP and Part 11 compliance in a Safety Pharmacology laboratory.

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