preview

Animal Testing Process Essay

Satisfactory Essays
The first step is called the preclinical phase which focuses on understanding a certain disease and breaks down the complicated components of the disease such as pharmacology and chemistry in order to develop a molecule that targets the disease. Numerous trials can be done to reach to a promising molecule that would be a starting point of that new medication. Secondly, the drug enters the animal testing stage which is required by the FDA. The FDA requires this step to determine the effective dosing of the medication and gives certainty that the medication is safe to move to clinical trials. After this step, the company will be able to fill the Investigational New Drug application, IND, which includes all the chemical and manufacturing data,…show more content…
Each phase takes a minimum of one year to be completed. The first clinical trial is driven mainly on healthy volunteers to determine the safety of the drug with very low doses. Nearly two thirds of drugs survive to the next phase of trials. This phase usually consists of 20-100 volunteers. The second phase is applied on patients with the targeted disease and usually consists of 100-300 volunteer patients. Many drugs fail in this phase as they prove to be ineffective treatment. If the drug survived in this stage, it will move to the third phase of clinical trials which lasts between 2-10 years. In this stage, the drug is tested on thousands of patients in different areas of the world to measure its effectiveness and determine the best dosing and formulary of the drug. This step is considered the most expensive, but usually less than 10% of the drugs fail in this stage. After that, the company has to fill the New Drug Application, NDA, which will have all the data of the clinical studies in order to go through the FDA review before the final approval. In addition, there is a fourth stage after the FDA approval of the drug to determine the effect of the drug in the long term use. Some drugs have been recalled from the market at that
Get Access