Although the term "Personalised medicine" is used quite loosely, it basically refers to the use of genetic or other biomarker data to guide patient treatment decisions. These judgments may involve determining which patients should receive particular medicines or dosages of a given drug, or which patients should be given closer monitoring because they are more likely to experience a certain safety risk. The study of genetic variants and their impact on how individuals respond to pharmaceuticals has been referred to as genetics, pharmacogenetics, personalised medicine, and pharmacogenomics. Although the term "personalised medicine" is used quite loosely, it basically refers to the use of genetic or other biomarker data to guide patient treatment decisions. These judgments may involve determining which patients should receive particular medicines or dosages of a given drug, or which patients should be given closer monitoring because they are more likely to experience a certain safety risk. The study of genetic variants and their impact on how individuals respond to pharmaceuticals has been referred to as genetics, pharmacogenetics, personalised medicine, and pharmacogenomics. In general, personalised medicine consists of two components. A drug, biologic, or other therapeutic intervention is the first, and a diagnostic test is the second. We had to create multi-centre personalised medicine policies that included the Centre for Diagnostics and Radiological Health (CDRH), the Centre for Biopharmaceuticals Evaluation and Research, and other FDA centres in addition to CDER's rules.
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