Humans have such a huge variety of drugs these days for the treatment of anything from cold and flu to cancer. While preclinical research can give some indication of a drug’s safety, it’s no substitute for real trials on how it the drug will interact with the human body.
At the beginning of the trial, drug developers will determine that they want to achieve for each of the various stages or ‘research phases’ of a trial. The goal of these developers is produce a new drug for the market with solid, proven therapeutic benefits. There are still high numbers of drugs that never make it to market, with less than 10% of those entering clinical trials ever being approved by the relevant regulatory bodies.
Trials are only a small part of what is involved in developing new medicines. Life-saving drugs of the future must first be discovered, made, purified, explained and tested in laboratory conditions before it ever reaching the phase of human testing. This is where many compounds fail and never reach the human testing phase.
Pre-clinical studies include monitoring the drug’s effect on cells. It’s a long, difficult and slow process which can take between 10 to 13 years from lab to regulation. During the pre-clinical phase, it is vital to determine the safest dose for the first introduction into human testing. This applies, not just to drugs but also devices, diagnostic tools and gene therapy solutions. Only one in every 5000 drugs or devices put forward in pre-clinical development will make become an approved treatment.
Often pre-clinical trials are not large, but they must incredibly detailed, providing in depth information on toxicity and dosing levels. After the pre-clinical trial has taken place, researchers have the opportunity to review their findings before deciding to take the process to the next step and begin phase 1 of clinical trials – introducing to human subjects. For more information on Adaptive Phase 1 Studies, visit www.richmondpharmacology.com/adaptive-phase-i-studies.php
What does pre-clinical research involve for:
Drugs – must go through a process called pharmacodynamics (how the drug effects the human body)
Pharmacokinetics (how the body effects the drug)
Toxicology testing to determine safe dosage
Studies of which organs are affected by the drug and any possible long-term toxic or carcinogenic effects or any impact on the reproduction in mammals.
Medical Devices – any that don’t have a drug attached to them will not need to go through the above testing but may move straight into lab testing to ensure safety. Some devices for use inside the body will undergo biocompatibility