The Purpose of Preliminary Testing for New Drugs

The Purpose of Preliminary Testing for New Drugs

The purpose of preliminary testing for new drugs is primarily to determine the safety and efficacy of potential substances, among many other drug characteristics along the way. Preliminary drug testing tests the safety and efficacy in three different phases. Each phase tests for various elements of safety and efficacy across increasing populations in order to obtain more data. Research institutions, big pharma companies, and pharmaceutical suppliers such as radiolabeled compounds suppliers rely on preliminary testing to ensure new drugs are safe and effective.   

Phase One  

The first phase of preliminary testing focuses on safety, rather than efficacy, and tests the smallest portion of people. Researchers conduct these tests on healthy volunteers to determine what the most frequent side effects of the drug are and how the drug metabolizes in human subjects. This phase is necessary to determine if a new drug's side effects are only acute and whether or not users will be in any danger due to the present side effects.   

Phase Two   

Phase two still monitors safety but focuses more largely on efficacy. Phase two gathers preliminary data on the drug’s beneficial effects. This phase tests the drug to determine if subjects with a certain disease or condition can benefit from the drug. Phase two is drastically important as it ensures the drug will work for the condition it is designed to treat.  

Phase Three  

Phase three combines both safety and efficacy by gathering further information about the new drug. Phase three is tested on a large and diverse population to gather a greater understanding of the drug. This phase further tests the product's effectiveness, monitors side effects, and compares the product's effects to a standard treatment method, if one is available. By opening the test to a greater population, researchers can discover less common side effects that weren’t present in previous phases. They may also uncover different dosages and information regarding how the drug works when taken with other prescriptions.   

The purpose of preliminary testing for new drugs is to ensure the drug is safe for patients and effective against the condition it was designed to treat.