The development of new medication is a long, multi-step process. This is to ensure careful testing and research is conducted, and that medicines are as safe and effective as they can be.
One important part of the development process is the preclinical trial phase, in which medication undergoes preliminary testing before it is ever administered to a person. This step is vital to ensuring that human test subjects who participate in later trials are not at great risk of harm.
Want to learn a bit more about preclinical trials? Here’s a closer look at why these trials are so important.
Graduates of Pharmaceutical Courses Will See Two Main Kinds of Preclinical Tests Performed
Preclinical research typically breaks down into two broad categories of testing: in vitro, and in vivo.
With in vitro testing, medicines will be tested on biological components—things like blood, cell cultures, etc.—inside of beakers, test tubes, flasks, or other vessels in a lab. It’s a good method for testing the specific effects a medicine might have on specific components of a person’s biology, but isn’t a great indicator of what might happen when a medicine is actually introduced to the more complex biological system of a living person.
In vitro testing helps determine a medicine’s effect on specific biological components
With in vivo pre-clinical testing, a medicine will be tested on an animal subject—often a rat, monkey, rabbit, or other mammal, although other animals can also be used. Though they are imperfect stand-ins for humans, animal subjects are similar enough to people to allow researchers to get a reasonably good idea of how a medicine will interact within the complex system of a person’s biology. Finding potential toxicity in animals is an important part of this kind of testing.
Often, multiple variations on both of these kinds of tests will be used during the pre-clinical phase, as this allows for the collection of many kinds of important information. Wherever you end up working after your pharmaceutical quality control courses, the work you do might either involve, or be heavily influenced by, the results of this stage of testing.
After Pharmaceutical Courses, You Will See Preclinical Trials Must Adhere to Strict Standards
Though human subjects are not directly involved in the preclinical phase of medical testing, there are nonetheless incredibly strict controls in place on the preclinical phase. These controls help ensure that preclinical testing is of high quality, and offers useful results that can help with the decision about whether to proceed with human trials.
Training to perform quality assurance in pharmaceutical settings will expose you to many of the standards that are important to this, and other stages of drug trialing. These include Good Laboratory Practices (GLP), which are designed to ensure results from testing are reliable, reproducible, and of high quality; Good Documentation Practices, which are meant to bring uniformity to the paperwork that is produced to document the results of trials, and other important processes. Knowing how to apply these methods while conduction preclinical trials will help you ensure that good and usable results arise from experiments your future workplace contributes to.
Standards for testing and documentation are hugely important to preclinical trials
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