1. Phase trials and the FDA approval process often require seven to eight years.
ID: 145396 • Letter: 1
Question
1. Phase trials and the FDA approval process often require seven to eight years. Raloxifene (2.28) (Figure 2.12) was initially approved to treat osteoporosis. After being on the market for several years, raloxifene was reported to be an effective treatment for certain forms of breast cancer. Estimate how much time would be required for clinical tri als and approval of raloxifene as a breast cancer treatment. Justify your answer. 2. The following list provides several problems that a drug candidate might show during the drug discovery process. Indicate the stage(s) in the drug discovery process at which the problem may be discovered. Options include preclinical testing, the three phase trials, and postrelease. . Causes extensive liver damage Insufficient efficacy Causes arthritis after several years with chronic use Interacts with certain cardiovascular drugsExplanation / Answer
Ans 1) Raloxifene was later used even as breast cancer treatment but before it was approved, it obviously had to go through multiple phases of clinical trials before its approval. It was initially approved as a drug that helped in the prevention of osteoporosis in December, 1997 and in 1999 it was approved for osteoporosis treatment. However, after years of clinical trial and tests, it was even approved as a breast cancer drug in post menopausal women with osteoporosis on 14th September, 2007. So, it took nearly 10 years for the completion of the clinical trials and approving the drug for use. It was found that the drug was effective in reducing invasive breast cancer through all the follow ups.
Ans 2) Three phase trials and Post-release
The three phase trials are the clinical trials which are actually done on humans to understand the effective of the drug and any potential side effects. The tests on humans starts from the clinical trials where phase-I clinical trials are the first tests that are done on small number of healthy humans volunteers. It is to identify if the drug is safe or not. The Phase – II trials are done on large group of patients and helps in testing the efficiency of the drug. It is majorly done on patients. The phase – III clinical trials is when the efficacy of the new drug is tested over 6 to 12 months in large number of population. Post-release monitoring is also a phase which is important and generally monitored to ensure that the drug is effective.
Related Questions
Navigate
Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.