Throughout the 20th and 21st centuries, modern medicine has saved countless lives. Thanks to drugs like insulin, penicillin and the polio vaccine, many deadly diseases are being kept at bay. However, pharmaceutical companies do not start distributing drugs at the slightest sign that they could cure or alleviate these diseases. In fact, most drugs must go through a long and tedious process of experimentation, testing, and trials in order 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 procedure: discovery and development, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring. Say no to plagiarism. Get a tailor-made essay on “Why Violent Video Games Should Not Be Banned”? Get an original essay According to the FDA, the initial stage of the drug development process is discovery and development. Laura Lansdowne's article, "Target Identification & Validation in Drug Discovery" provides a more in-depth look at this step. She asserts that drug discovery begins when pharmaceutical scientists find a suitable “target” – a biological entity that both addresses the disease and can be modified by therapeutic measures. Essentially, it involves identifying a “cause” of the disease so that it can be treated with the drug that will soon be developed. This is followed by target validation, where numerous experiments are performed on the aforementioned target to confirm that it actually plays a role in the disease. Then the actual development of the drug begins. Scientists are now looking for drugs that can affect the target. At this point, over ten thousand compounds are selected and tested in a brute force trial and error strategy. Drugs that pass testing are then developed and modified by scientists in hopes of improving their effects on the target. Drugs that advance through discovery and development are the subject of what is called preclinical research. In preclinical research, the potential dangers of a drug are evaluated in toxicological studies. These studies are generally carried out using one of two methods: in vitro, which are experiments carried out in test tubes and petri dishes, and in vivo, which are experiments carried out on animals such as mice, rabbits and monkeys. As the FDA states, “preclinical studies must provide detailed information on dosage and toxicity levels.” This is particularly important because these drugs will be tested on humans in clinical research, where dangerous drugs can lead to injury or death. Before clinical research begins, however, scientists must complete the investigational new drug application, in which they include information such as manufacturing details and data on the drug from previous research. Then, clinical research begins with phase I, where the drug in question is tested on a small group of 20 to 100 people with the target disease. This phase lasts several months, during which scientists try to determine how safe the drug is and the appropriate dosage to administer. The next phase, called phase II, consists of testing with hundreds of participants. Its objective now is to test the effectiveness of the drug in/.