Pharmacogenetics in Pain Management and the Use of Pharmacogenomics Methodologies in the Pharmacovigilance Evaluation of Medicinal Products
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The presenters will discuss how pharmacogenetics can be integrated in clinical trials.
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Pharmacogenetics in Pain Management and the Use of Pharmacogenomics Methodologies in the Pharmacovigilance Evaluation of Medicinal Products
- 2. 12/13/20162 Problem Known risk factors all together can explain 5- 20% of inter-individual variability in most painful disorders (e.g., chronic postoperative pain, TMD, CRPS) What do we miss? VP =VE + VG Biology is the study of how we are the same. Genetics is the study of how we are different.
- 3. 12/13/20163 Genes Implicated in Human Musculoskeletal Pain Conditions Diatchenko, L. et al., 2013, Nat. Rev. Rheumatol.
- 4. 12/13/20164 Molecular Diagnostics as Predictive Tool
- 5. 12/13/20165 • Improve patient safety • Improve clinical outcomes • Reduce time in drug development Goal of Genetic Testing in Analgesic Drug Development
- 6. 12/13/20166 6 Identify right responders / non-responders Minimizing toxicity Adjusting drug dosage Optimize Efficacy Optimize Therapies Personalized Medicine
- 7. 12/13/20167 7 Pre-clinical studies Clinical studies Adverse Drug Reaction case reports Epidemiological studies Pharmacovigilance Surveillance System Genomic Material Sampling Collaborations Pharmacoepidemiological Databases Source of Pharmacogenomic Data Collection
- 8. 12/13/20168 8 Consider potential risks Explore risk minimization measures Increase safety and efficacy Think of reverse effects Think of synergy effects Risk-Minimization Process Pre-Marketing Phase dRMP section Part V – RMM Biomarkers and Risk Minimization
- 9. Copyright © 2016 Honeycomb Worldwide Inc. Click here to watch the complete webinar: or Click here for more information on this presentation: http://xtalks.com/Pharmacogenetics-in-Pain-Management.ashx POWERED BY HONEYCOMB Copyright © 2016 Honeycomb Worldwide Inc.