With genomic data becoming integral in the diagnosis of more diseases and delivery of more therapeutics, this consultation into a revision of the existing guideline from EMA will impact the future of drug development.
The Concept paper laying out EMA's current plan and proposal with the directions for commenting, as well as a link to the current effective guideline may be found here: Good pharmacogenomic practice - Scientific guideline | European Medicines Agency (EMA)
#EMA #Pharmcogenomic
| European Medicines Agency (EMA) |
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| Good pharmacogenomic practice - Scientific guideline | European Medicines Agency (EMA) |
| This document describes requirements related to the choice of appropriate genomic methodologies during the development and the life-cycle of a drug. It discusses the principles for a robust clinical genomic dataset. It also highlights the key scientific and technological aspects for the determination and interpretation of the genomic biomarker data and their translation into clinical practice. |
| View this on European Medicines Agency (EMA) > |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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