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the microsampling blog

how blood microsampling fits into the drug development process

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There are various stages involved in drug development, which is just one part of the preclinical research process.

New drugs must undergo rigorous trials and evaluations before they get to the end user, the consumer.

Here is a breakdown of the stages of drug development:

Discovery – At this stage, scientists are involved in choosing a molecule such as a protein or gene and they must confirm that it is associated with the disease in question. After conducting multiple tests, the scientists choose the most promising drug molecules.

Preclinical research – After choosing the most promising drug molecules, scientists then begin preclinical trials. These are divided into in vitro and in vivo testing. In vitro involves observation of the drug molecules and how they interact in a lab setting. This is usually done in test tubes.

In vivo testing is testing the molecules on animals and living cell cultures. The animal testing may begin to bear visible fruits, but the test won’t move to humans until extensive research on the drug safety is performed. This stage usually takes years to confirm possible side effects of the drug molecules as well as their efficacy. The most promising molecules at the discovery stage might have numbered in the thousands; at this stage, the scientists might narrow them down to between one and five.

Investigative New Drug (IND) application filing – After those early stages of the drug development process have been completed in the United States, an IND application is submitted to the Food and Drug Administration (FDA). The FDA critically scrutinizes all aspects of the drug and decides if it’s safe for the scientists to proceed to the next stage — human clinical trials.

Clinical trials – The clinical trials stage is similar to preclinical trials; the only difference is that the clinical trials involve human beings versus animals.

How Blood Microsampling Fits into the Drug Development Process

The preferred animals for preclinical research are rats and mice. Due to the amount of blood drawn from these animals, a large number of them die. While this is obviously unfortunate for the animals, it also may affect the study results. With the use of microsampling, the amount of blood that is collected from each animals is very small. Each blood sample is micro-sized, making it a less invasive experience for the animal, and making it possible to continue a study using just one mouse that previously used three mice.

Microsampling Provides Comfort and Convenience and Can Cut Costs

In preclinical studies and clinical trials, microsampling offers comfort and convenience for the test subjects. Consequently, pharma and drug development companies don’t have to spend more budget on using satellite animal populations for their animal studies, or on the retention of study volunteers in their human-based clinical trials. This frees them to focus less on the research challenges and more on the drug development study itself.

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