Precision medicine aims to maximize benefits and efficacy of drugs for specific people or particular groups. Variables in different individuals are taken into account when preventing or treating diseases, rather than lumping large populations together with a one-size-fits-all approach. These variables include lifestyle, genetic profile, and environment. Precision medicine is gaining traction and will be taken into account in the future of research and development, but the idea isn’t brand new. For example, blood transfusions with donor matches have been used for a very long time.
If you plan on studying pharmaceutical research and development, read on for more about this personalization of medicine.
N-of-1 Trials after Pharmaceutical Research and Development Training
Historically, clinical trials have often been population-based. Groups of people are used for these trials and the average responses are recorded, though often the findings of these trials end up helping only a small number of people in the long run. Often, these trials produce unsatisfactory results and have been followed up by impromptu post-trial analyses on individual participants, to clarify why their responses occurred. This introduces the need for trials that are more focused.
Trials that are conducted on a single person are called N-of-1 trials, giving insight into drugs’ effects on specific individuals. Learning how to assist with innovative drug products is a part of pharmaceutical research and development training that could be applied to these trials. Crossover designs may be used, which alternate different interventions or treatments to compare their effects. A ‘wash-out’ period can be used in crossover trials, allowing effects of a previous drug to wear off before administering a new one.
N-of-1 trials are useful for precision medicine because they can be used in the early stages of development or for repurposing drugs in new contexts. Individual responses are recorded, rather than average results. This specificity allows for development of personalized treatments.
What Variables can Precision Medicine Tailor to in an Individual?
Individualized drugs can be adjusted to provide appropriate dosages for different metabolic profiles. Different amounts will work better for patients with fast or slow metabolisms because of how they process medicine. You may know after a pharmaceutical research and development program that other well-known factors like age, kidney function, and cigarette smoking can affect how people process drugs differently.
Genomic profiles can also be catered to with precision medicine. Variations, or polymorphisms in genes inform how enzymes metabolise drugs in the liver. Different polymorphisms can prevent a drug from converting into its active form or cause a build-up of an active drug in the body. In this way, genes can affect required dosage or effectiveness of a treatment.
Better Data for Pharmaceutical Research and Development Program Students
Individual solutions can be determined when more data is available for each patient. From understanding what mutation led to a disease, to data on behaviour that has been collected over time, this can give experts an advantage when treating patients. Instead of applying treatments that worked on average for a broader population, this data would help determine choices that will most likely benefit the person being treated.
A goal for some is to create a rich data ecosystem for each patient, easily accessible and to be consulted when making decisions around medication. This can help with precision medicine because the more that is known, the more informed decisions will be. This goal has been challenged by barriers around data sharing policies, interoperability, and siloed data collection.
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