The Drug Development Process: 3 Essential Steps

Medications and vaccinations are essential to everyday life. Over the years, there have been tens of thousands of medications that have been developed in order to help with everything from chronic pain management to life-threatening diseases.

Typically, it takes anywhere from 10 to 15 years to develop a medicine or vaccine. Researchers, scientists, and healthcare professionals are constantly updating their laboratory notebooks and making strides toward revolutionary breakthroughs within the scientific and medical sector.

How does a drug, medication, or vaccination go from the pages of laboratory notebooks to pharmacies, doctor’s offices, and medicine cabinets around the world?

The Drug Development Process

The success rate of experimental medications making it to pharmacy shelves and medicine cabinets is actually quite low. Currently, there are more than 180,000 ongoing clinical studies across the U.S. and world. That being said, since the Food and Drug Administration (FDA) came into existence in 1938, only 1,453 drugs have been approved through the end of 2013. Similarly, according to, only five out of every 5,000 preclinical drugs will ever be tested on humans.

Here are a few essential steps that need to be taken during the drug development process:

  • Discovery and target validation — First, discovery work needs to be done. This is where drug development organizations select a molecule, such as a gene or protein, to target with a drug. This is also where pages and pages of scientific notebooks are filled with thoughts, notes, ideas, and more.
  • Preclinical testing — Next, in vitro and in vivo testing begins. In vitro testing takes a look at how the drug’s molecules interact inside test tubes. In vivo testing involves testing those molecules on living cell cultures (not humans).
  • Clinical studies — The third step actually involves three separate phases of clinical studies. Phase 1 involves a relatively small group of healthy people and focuses entirely on safety; phase 2 involves 100 or more patients who are no longer healthy volunteers; and phase 3 studies are designed by drug developers and approved by the FDA with guidelines for clearly defined primary endpoints to determine the success or failure of a drug being tested on a specific health condition.

If you want to learn more about the medication or vaccination process, or find high-quality laboratory notebooks to keep track of all the information you obtain along your scientific journey, contact Scientific Notebook Company right away!