Phases of drug development
- Basic Research/Drug Development
New potential * are discovered at this stage. At this point, the investigators test their ideas at the laboratory bench and in machines or “test tubes, ” but the experiments can also involve cells and specially-bred animals. The potential treatments can be made from all sorts of materials, including natural or synthetic chemical compounds and bioengineered or biological materials, like antibodies. Some are “repurposed, ” meaning that they have been approved for treatment of one or more disease(s) and are being tested for their potential to treat another disease.
Much of this basic research is done to determine more details about the disease studied and what proteins, genes or system processes contribute to the development and/or progression of the disease. These clues to potential avenues for treatment are essential to be able to design drugs for further testing. The clues can also help with designing large “high-throughput” drug screening techniques.
Only potential treatments that have the best evidence for potential safety and effectiveness in animals and humans move forward to . The list of treatments is whittled down to much smaller numbers as some make it past the tests and others do not.
- Pre-Clinical/Translational Research
The potential * identified to have therapeutic potential in the stage are then tested in animals for their ability to be delivered to the target organ(s) and tissue(s), to determine how well they are cleared from the system, and to determine their toxicity, safety, and effectiveness. Many potential treatments that do not pass certain tests may be “dropped” at this stage, since they may seem too risky for further development for use in patients.
Normally, one of the Pre-Clinical tests must involve a type of animal that has a condition similar to one or more symptoms held by human patients of the particular disease for which a treatment is being pursued.
Translational Research involves studies that give evidence that the effectiveness shown for a particular treatment has a good chance that similar results could occur in humans. Essentially, the research must show that the results can “translate” into helping patients who have the disease or condition.
Many promising treatments are never tested in clinical trials due to lack of funding or other business difficulties. In many cases, further financial support or partnerships are needed to help “bridge the gap” across the “”** to begin Phase 1 Clinical Trials.
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