Vilvet Pharmaceutical on How a Pharmaceutical Drug is Developed and Tested Before Being Distributed
As new advances in science and technology are reached every single day, new ideas and innovations are put to the test to bring forth products that are helpful to society, and the pharmaceutical industry is one of the largest in doing so. Yearly, hundreds of companies throughout the nation and worldwide work hard to research, develop, test, and bring to market new drugs for patients. Vilvet Pharmaceutical is a company based out of Pennsylvania that understands technology and medicine go together, and they are committed to innovation and technology, while working with other drug developers to support clinical trials and helping to manufacture and distribute these drugs. As a whole, the industry will test thousands of drugs yearly, with studies ongoing for an average of 12 years before coming to market, with the US Food and Drug Administration (FDA), giving the final approval. Of all the trials, only a handful ever makes it to market, with 59 being approved in 2018.
Research and Development
The discovery of a new drug will usually begin in a lab, usually at a university level, where researchers will have been given grants by pharmaceutical companies or research bodies. They are tasked to gain a better understanding of a particular disease process, the molecules, receptors, pathways etc. involved, and potential ways of halting or reversing these processes. Researchers then work tirelessly to test various molecules and compounds to find ones that may be effective, working with natural, and growingly genetic material to produce molecules and proteins. They will generally also look at previous treatments, side effects, and efficacy and dose responses to see how they may be able to better improve on those aspects. Vilvet Pharma explains that thousands of molecules and proteins will be studied extensively, and of those only a handful will be chosen as candidates that could potentially help combat the disease process being researched. These are then studied even further to better understand their safety and efficacy using both animal and computerized models, while also looking at how the compounds are used by the body (absorbed, metabolized, excreted).
Clinical Research
Once safety has been established, the compound can now be considered a drug that can be tested in humans, and can go through the Investigational New Drug Process (IND). Research must establish what they would like to accomplish in the various phases of clinical research, and can work with the FDA getting guidance on how to go about conducting the research. There are 4 phases of trial the drug must go through, and prior to that, researchers must decide on selection criteria, the population being tested, length of the phases, how they will limit bias, what dosing will be given, and even how the data collected will be interpreted. Vilvet Pharma is committed to helping develop and support each clinical phase and once established, phase 1 of trials can begin with usually a small cohort of healthy participants who have the disease or disorder. This phase is done over several months, and is done to test the safety, and dosage of the drug, with approximately 70% of drugs making it to phase 2. During this phase, hundreds or even thousands of patients are given the drug for up to 2 years to further test for its efficacy and side effects. This phase is generally done to help guide researchers in refining their study questions for the next phase, as the benefit of the drug cannot be assessed yet. In phase 3, a few hundred patients are given the drug for anywhere between 1 to 4 years to further analyze the benefits and side effects of the drug. Phase 4 is conducted for years over thousands of patients after FDA approval to continually monitor patient safety and efficacy.
Review
If during clinical trials, researchers believe the drug to be safe and effective, they can undergo the FDAs New Drug Application (NDA), where the drugs full history from research and development, to phase 3 trials is outlined in detail, as well as proposals on matters such as packaging and labeling, safety, patient information, and directions for use. Vilvet Pharma explains that the FDA then reviews all the information with the highest level of scrutiny, with clinical site visits and documentation review, and a recommendation is given on whether the drug should be approved or not. If it is deemed that the drug is both safe and effective and passes all levels of inspection, it is then approved, and followed by the FDA.
