Regulatory Authorities are now requesting that blood samples are collected for Pharmacogenetics research as part of clinical development programs. These samples may be used to generate genetics data if there is evidence of variability in clinical response to the drug. In other words, Pharmacogenetics research is often initiated after the results of the original study have been reported. This can cause problems for the project as it could lead to considerable delays, additional costs and problems with finding the appropriate resources.
In addition, the PGx experiment may have little chance of success as there is actually no genetic effect on variability or there are not enough available samples to answer the genetics question. They work with customers to help them understand the PGx opportunity by using the following approaches:
• Use Data displays to show variability in response and to identify subjects with a clinically meaningful response
• Use statistical models to uncover latent classes (subgroups) in the data
• Evaluate other possible explanatory variables
• Estimate the probability (power) to detect clinically useful, genetic effects
by
Akshaya Srikanth
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