Drug Development
Before a new drug is introduced to the general public, it has to undergo a rigorous process of drug development.
It has to be effective and safe to use, as well as provide little harm to users. Sometimes, it takes many years of medical research before any medical product is cleared for public use.
Nonetheless, recent developments in the medical industry and the evolving technologies that create today’s cures and treatments facilitate in the speedy discovery and development of more efficacious and safer options.
BioRap Technologies Ltd., an Israeli leader in the area of drug development »
The Stages of Drug Development
The stages of drug development can be classified into two general processes, the pre-clinical and the clinical stages. The former involves a process called drug discovery.
This is the stage where new and promising chemical compounds are studied and analyzed to determine their molecular structure or chemical makeup, safety, toxicity, solubility, stability and other important features.
The chemical compounds are then analyzed to determine safe dosages for human use. Oftentimes, this stage in drug development puts stress in ensuring that every regulation required by drug licensing agencies is satisfied.
Drug development does not end after the trials. The long term effects of the drugs have to be observed and studied before they can be introduced in the clinics.
The pre-clinical phase provides vital information which can then be submitted to regulatory authorities, such as the FDA in the United States.
Once authorized, the drug development can move on to the clinical stage, which involves three important trials:
- In Phase I trial, the drug is tested on healthy volunteers to determine correct dosage and safety.
- The drug then goes into Phase II where it is administered to sick patients to determine efficacy.
- Phase III involves testing the drug on a larger number of patients.
Drug development does not end after the trials. The long term effects of the drugs have to be observed and studied before they can be introduced in the clinics.
The compounds found in the drug have to be tested for toxicity and carcinogenic properties as well.
Once a drug has shown efficacy in the clinical trials and passed all safety regulations, it can then move to the marketing stage and be made available for the public.
Prospects of Modern Drug Development
Many drug development centers all over the world are aiming to come up with safer and better drugs and therapies to treat illnesses plaguing many people today.
Stem cell research by Bioline, for example, is continually providing hope for cancer patients all over the world. Stem cells may also be used to discover new treatments for cardiovascular diseases.
Nanotechnology is also a promising medical technology, which may completely provide a better alternative to the painful chemotherapy sessions.
Posted in Health