Nature Of The Drug Store - 1008 Words

â€Å"Nature to the drug store† is an interesting phrase to describe the series of steps a drug undergoes before it is brought to the consumer. When one thinks of the nature aspect of a drug, they might think of natural sources from plants and/or animals. Although this is true, †¦ Professor Akala recalls as a student having to go to the bush to collect plants to extract them in lab. He also recalls that insulin used for diabetes was taken from pigs in his time. Now, he states, â€Å"insulin is being extracted from bacteria and being used on the consumer. â€Å" Although drugs have revolutionized throughout the past several years, natural sources seem to be a rich source of new drugs. According to Mongabay news, â€Å"around 70% of all new drugs in the United†¦show more content†¦Important factors include drug solubility, partition coefficient, dissolution, physical form and stability. For example in terms of stability, aspirin solution and aspirin suspensions are never seen as dosage forms because it is not stable in water. In order to test your drugs on human subjects, the company with the new drug is required to file with the FDA and submit an Investigational New Drug (IND) application. The FDA has 30 days to respond to your request. In the rare case that they do not respond, your company has the legal right to begin testing on human subjects. The FDA may issue a hold if they have any concerns regarding your drug. The FDA can choose to put your file on clinical hold in which an order is issued by the FDA to hold clinical trials on human subjects. There are two main types of IND’s. One type is treatment IND. This treatment protocol allows the use of an investigational drug in the treatment of patients not enrolled in the clinical study but who have a serious or immediately life threatening disease such as cancer and Parkinson’s disease, for which there is not yet a cure. The second type is IND for Orphan Drug. This protocol is under the orphan drug act of 1983. The FDA provides grants and scholarships for pharmaceutical companies to conduct clinical trials on new drugs for rare disease. These rare diseases are classified as diseases that affect fewer than 200,000 people in USA. Some diseases include AIDS and cystic fibrosis.