The Process of Bringing Drugs to the MarketOctober 7, 2014
Pharmaceutical drugs are chemical substances formulated to cure, treat or prevent an illness. They can be classified as oral contraceptives, painkillers, antimalarial, antibiotics, stimulants and antiseptics to name a few, and can be administered in various forms including vaccination, tablet, topical cream or capsule. Drugs are crucial to preventing sicknesses from spreading, and also help us live daily life with less interference from pain and sickness. While it may seem like new drugs are appearing on the market every day, you can be assured that all drugs must undergo a standard procedure of research, trials and FDA approval before they reach drugstore shelves. Project management training will teach you how to manage pharmaceutical projects and bring them to the market, through the required procedures below.
Drug Discovery & Laboratory Studies
This stage is also known as “pre-clinical”, and precedes any sort of trials or human testing. Laboratory research is performed to determine the toxicity and metabolism of new chemical entities within the drug before they are used by humans. Scientists will determine a dosage and potency of a drug during this stage as well. Pharmaceutical laboratory training will provide researchers and scientists the ability to accurately inspect operations of laboratories and carry out audits if necessary. This is critical to protect the safety of the public and ensure money is not lost forming a drug which will not be approved due to improper laboratory conditions.
At this point in the drug development, someone from a drug safety and pharmacovigilance program will design and write study protocols, and regulate the clinical trials. These workers are necessary to ensure that trial patients are treated well and are not in danger. Clinical trials usually occur in three stages. Stage 1 will use healthy volunteers to determine proper dosage. Stage 2 will further explore the effects of the drug on a small number of sick patients, and Stage 3 will determine the effect of the drug on a large number of patients. Carcinogenicity testing, or the testing for the ability of a drug to cause cancer, is also a critical trial in clinical testing.
In North America, the government branch which oversees drugs going onto the market is the Food and Drug Administration (FDA). On average, it will take a drug 12 years of laboratory and clinical testing before it is approved by the FDA. The administration’s green light is already necessary in order to undergo clinical trials, but following these trials, a formal application (generally around 100,000 pages) will be sent to the FDA for approval. This process can take up to three years, and when final approval is given, doctors may begin to prescribe the drug. Even after a drug has been brought to the market, the drug company must continue to record and study data from patient trials and submit this data to the FDA in order to monitor any adverse reactions or changes in the drug.