Topic > FDA Drug Development Process

Throughout the 20th and 21st centuries, modern medicine has saved countless lives. Thanks to drugs such as insulin, penicillin and the polio vaccine, many deadly diseases are kept at bay. However, pharmaceutical companies do not start distributing drugs at the slightest hint that they might cure or mitigate these diseases. In fact, there is a long and tedious process of experimentation, testing and trials that most drugs must go through to be deemed effective for treatment and safe for the public. This process is called the drug development process and is commonly recognized as a five-step process: discovery and development, preclinical research, clinical research, FDA review, and FDA postmarket safety monitoring. Say no to plagiarism. Get a tailor-made essay on "Why Violent Video Games Shouldn't Be Banned"? Get an original essay According to the FDA, the initial phase of the drug development process consists of discovery and development. Laura Lansdowne's article, “Target Identification & Validation in Drug Discovery” provides more in-depth insight into this phase. She argues that drug discovery begins when pharmaceutical scientists find an appropriate “target” – a biological entity that causes disease and can be modified by therapeutic measures. Essentially, it is the act of identifying a “cause” of the disease so that it can be treated with the drug that will soon be developed. What follows is target validation, where numerous experiments are performed on the said target to confirm that it truly plays a role in the disease. Subsequently, the actual development of the drug begins. Scientists are now looking for drugs that can affect the target. At this stage, over ten thousand compounds are selected and tested in a brute-force trial-and-error strategy. Drugs that pass testing are then further developed and modified by scientists in the hope of improving their effects on the target. Drugs that advance through discovery and development go through what is called preclinical research. In preclinical research, the potential dangers of a drug are evaluated in toxicology studies. These studies are usually conducted using one of two methods: in vitro, which is experiments conducted in test tubes and Petri dishes, and in vivo, which is experiments conducted on animals such as mice, rabbits, and monkeys. As the FDA states, “preclinical studies must provide detailed information on dosing and toxicity levels.” This is especially important because these drugs will be tested on humans in clinical research, where dangerous drugs can cause injury or death. Before clinical research begins, however, scientists must fill out an Investigational New Drug Application, in which they include information such as manufacturing details and data about the drug from previous research. Subsequently, clinical research begins with Phase I, in which the drug in question is tested on a small group of 20 to 100 people suffering from the target disease. This phase lasts several months, during which scientists try to determine how safe the drug is and what dosage is appropriate to administer. The next phase, called Phase II, consists of tests with hundreds of participants. Its aim now is to test the drug's effectiveness in treating the disease and to further explore side effects that patients may experience. Phase III is similar to Phase III, but the most significant difference is the scale of the experiment. The number of participants in this phase can reach thousands and/.