Drug Development Process

It could take 10-15 years to develop a new drug. The process of drug development is long, starting from formulating the substance, testing it on animals (which we call Pre-Clinical studies) for safety, testing it on human subjects (which we call Clinical studies) for safety and efficacy. Once it's proven to be safe and efficacious, meaning that the drug is safe and effective on humans for the particular disease, it can then be marketed.

To many, this may seem like a very long process, however, it can save lives, prevent and cure diseases around the world.

Let's work through the steps:

Step 1 - Studying the normal and abnormal functions of the body

What do we really look at here? First of all, we need to know about the human body and study the normal and abnormal functions of the body.

Step 2 - Investigating the Diseases

Then we would think about what disease we would like to concentrate on (which therapeutic area to focus on). There are many diseases that are fatal, such as cancer, heart failure, lower respiratory infections, malaria, HIV/AIDs, and of course right now the focus is on Avian flu (H5N1 strain). After deciding on the disease, we need to know the symptom(s), the cause(s), the target organ(s) and the biochemical pathway(s) of this disease.

Step 3 - Gathering information

Further information would be gathered from previous studies/research done and publications, to understand the disease better, in order to treat the disease.

Step 4 - How can we stop the disease from progressing/developing??

Find out at which point we can stop the disease from progressing or developing. Basically, we need to find OUR TARGET!

Step 5 - Search for targeted Drug

It can be
- Chemically synthesized compound
- Biologically synthesized compound
- Computer simulated compound

Step 6 - Isolation of the compound

Step 7 - Pre-Clinical studies

Tests will be performed on animals to gather safety data. The researchers will look at the toxicity and carcinogenicity of the compound.

Step 8 - Approval to be tested in humans

Once the compound has been proven to be safe in the pre-clinical stage, the compound will have to be approved to be tested on humans. When it's approved, we can then proceed to test it on humans.

Please see next posting for Clinical Studies stage to marketing the drug.