New drug development process is a lengthy and costly process which can be terminated at any time during the development process. Several reasons can contribute to abandoning the process and some of them would be presence of dangerous compounds or if the drug is irrelevant to the intended users. The process of delivering the drug into the market takes considerable time and it can take more than a decade. This paper will discuss the process of delivering a new drug into the market as well as give an example of a new drug that has been approved.
New Drug Development Process
New drug development process has three major steps that cost the company over $500 million. The first step starts with preclinical studies. At this stage, new drug is tested on animals with the primary aim of examining its pharmacological and therapeutic compounds as well biologically dangerous compounds. The second process is the Investigational New Drug Application (IND). At this stage, the drug is submitted to the Food and Drug Administration (FDA) for approval before testing it on human bodies. The company is expected to give details with regard to compound composition, protocols to be applied in Phase 1 and the clinical research plan. More than 5000 compounds are submitted for clinical testing but only one of them is approved for marketing (Sharp, 2001).
Approval is granted within a period of one month and this marks the onset of clinical testing on human beings and comprises of three phases. In the first phase, the drug is tested on a few healthy individuals (10-30) to ascertain that the drug is safe and can be tested on patients. Phase 1 focuses on safety but not drug’s efficiency (Sharp, 2001).
Phase 11 utilizes a larger population sample of about 100 to 200 and it is conducted on patients with the condition the drug is expected to treat. The primary aim of this face is to ascertain that the drug will be of use and determine the appropriate dosage. The last phase of the clinical testing takes about 2-10 years and entails testing the drug on a larger population of patients. The primary aim of this stage is to affirm that the drug is effective and it is better than other drugs that have been approved for the same purpose as this drug. Phase 111 marks the end of the second step (International new Drug Application) and marks the beginning of the third step which is New Drug Application (Sharp, 2001).
New Drug Application gives the details of all the information collected during the first two steps of preclinical and clinical testing. It is forwarded to FDA after the drug passes through clinical testing. The application describes “the chemical makeup and manufacturing process, pharmacology and toxicity of the compound, human pharmacokinetics, results of the
Clinical trials and proposed labeling” (Bringing A new Drug to market n.d). NDA application is reviewed by FDA which either rejects or approves the drug. If the drug is approved, it enters the market but if declined, FDA gives the rationale for the decline. At times, FDA may require the company to make some adjustments before approval.
IFEX is a drug that is used n treatment of cancer and it was approved on first march, 2012 after passing all the tests required for approval (All approvals, March 2012. (n.d)
New drug development process has three major steps which include preclinical research, investigational new drug application and new drug application. All new drugs must pass through these steps before marketing.