Every drug has to go on a long journey before it ends up on a pharmacy store shelf. This is essential for ensuring that each new medicine is safe, effective and compliant.
Understanding this process is crucial if you think you may have just discovered a new drug and want to introduce it to the market. In this article, we’ll take a brief look at the different stages of testing and what they involve.
Preclinical trials
The first stage of developing any pharmaceutical drug is preclinical trials. It’s possible you may have a wide range of potential chemical compounds to choose from and you need to weed out the unviable candidates.
Sophisticated computer models can help to simulate drug interactions and predict potential outcomes. Trials can also be carried out on cells and organic matter. This may eventually involve testing your drug on animals like rats (some drug development companies are against animal testing and will skip this stage).
Third-party lab testing companies like this BioPharmaSpec Freiburg characterization facility may be used to test the compound for stability and purity. Outsourcing can reduce costs and may be necessary if your lab is not equipped with the right equipment and expertise.
Clinical trials
The next stage is clinical trials (testing the drug on human beings). This typically consists of three phases:
Phase 1
A small group of healthy volunteers is chosen in the beginning for testing. This phase typically focuses on finding the correct dosage – increasing the dose in gradual increments until adverse effects become noticeable. This phase can also help identify any unwanted reactions. This Icon guide to phase 1 clinical trials explains more.
Phase 2
This phase moves towards targeting patients who already have the disease your drug aims to treat. Hundreds of participants will be involved in this stage and each one will have to be monitored closely to measure the effectiveness of the drug and check for side effects.
Phase 3
If the previous phases are a success, the next and final stage of clinical trials can be carried out – which involves testing it upon thousands of subjects. This helps to confirm that there are no overlooked risks by targeting a much larger pool of patients of different demographics.
Getting approval
For a drug to be legally sold in a certain country, it must be approved by the regulatory body governing that country. In the US, all drugs must be approved by the FDA. In the UK, the MHRA approves all drugs.
Getting approval involves sending over all test results at each phase of the testing process. These are carefully scrutinised – if there are any issues flagged up such as unexpected toxicities, adjustments will need to be made and the drug may have to go through the entire testing process again.
After approval, expect periodic inspections. Manufacturing processes will need to be carefully monitored to ensure consistency. If any problems are discovered, your drug may need to be recalled. Avoid this by carrying out your own rigorous quality checks.
Conclusion
As you can see, pharmaceutical testing is a very thorough process. Do not expect your drug to be on the market any time in the near future – the entire testing process can take 10 years or more to carry out. You will need to secure a lot of funding to support this testing process.
Fortunately, there are many grants, charities and venture capital firms out there that you can choose from.