The pharmaceutical industry holds a vital role in the global healthcare sector. This is the industry that discovers, manufactures, and markets pharmaceutical products and medical devices for clinical and for consumer use. If pharmaceutical companies do not exist, there will be no drugs or medications to use to treat disorders or to cure or prevent illnesses.
The global COVID-19 crisis motivates researchers and scientists to quickly come up with a vaccine and a cure for the COVID-19, a new and highly contagious strain of the coronavirus. More than a dozen pharmaceutical companies are currently attempting to develop drugs to battle the COVID-19 outbreak.
New pharmaceutical products, however, must go through several processes before it can be rolled out for use. According to the Food and Drug Administration (FDA), the following methods are included in the development of new drugs:
- Discovery and development: Millions of dollars are spent on research and development to come up with new pharmaceutical products.
- Pre-clinical research: Preliminary testing is usually done on animals to review the merits of a new drug or a medical device.
- Clinical research: Once the product passes the pre-clinical trials, it moves on to the clinical trials. Clinical research involves testing on humans. This is considered as one of the most crucial steps in the development of new pharmaceutical products,
- FDA review: Pharmaceutical companies submit their findings to the FDA who will then review and approve the drugs after due deliberation.
- FDA post-market safety monitoring: Safety monitoring after post-approval involves checking drug advertisements for accuracy, reviewing complaints, and implementing drug warnings. In addition to its involvement in drug patents and generic transitions, the FDA also performs inspections of the manufacturing of approved pharmaceutical products.
Why is it Important to Test New Pharmaceutical Products?
The recent global pandemic is proof of how vital pharmaceutical companies are to the world. We rely on science to come up with solutions to problems through research and testing.
Research and development are one of the main activities that the pharmaceutical industry is involved in, Pharmaceutical research and development (R&D) activities are a source of medical innovation, but they are still required to prove the safety and efficacy of their products at pharmaceutical testing labs. Here are the reasons why it is crucial to test new pharmaceutical products:
To Ensure Public Safety
Pharmaceutical products are developed to treat diseases and health conditions. However, just because a new drug or compound was discovered, it does not necessarily mean that it is safe for human use.
Clinical trials aim to ensure the safety of new pharmaceutical products before doctors can prescribe them. Pharmaceutical companies are required to perform clinical tests on new products to make sure there are no adverse side effects to patients. Any known side effects should be reported to the FDA who, on approval, will authorize the commercial distribution of pharmaceutical products.
To Establish Efficacy
Aside from a new drug’s safety, its efficacy is established during pharmaceutical clinical testing. Pre-clinical trials are usually done with animals as subjects but results need further testing on humans. Moreover, every person has a unique genetic makeup so that the response to a drug will differ from person to person.
The pharmaceutical company or a third-party firm will validate the effectiveness of the products by checking how it alleviates symptoms or cures diseases through clinical testing. The results of these tests aid in translating the research for application in a real-world setting.
To Confirm Correct Dosages
The testing of new pharmaceutical products is also instrumental in confirming the right dosages for treatment procedures. Clinical testing may start using a low dosage of the drug and increasing it until the optimal dose is achieved. Pharmaceutical companies will not stop at establishing the efficacy of the new drug – the correct dosage must be reported to the FDA by the manufacturer.
To Compare with Existing Drugs
Existing drugs and medications are not necessarily better than new pharmaceutical products. However, drug manufacturing companies can refer to the research study of existing drugs to help them create a new drug with fewer side effects or one with improved efficacy.
Comparisons also work both ways. For instance, pharmaceutical companies with existing medications in the market can improve their products by utilizing the insights of new drug research. In essence, testing new drugs also paves the way for future clinical research, which will then benefit the pharmaceutical and healthcare industry as a whole.
Takeaways
Clinical testing aids medical research by confirming the right dosage, establishing the efficacy, and ensuring the safety of new pharma drugs. Testing new drugs is the best way to determine and prove what works and what doesn’t. Our world needs all the help it can get. Thanks to science and research, we are steps closer to finding cures.
About Author
Rafael Odom is a pharmacist by profession. With over twenty years in the industry, Rafael has seen how the healthcare industry has evolved. His experience makes it very easy for him to produce articles that can help the general public understand the importance of medications and keep them updated on the latest trends in the healthcare industry.