You are working on a drug called Cerebrolysin, (CBL) which is a mixture of pepti

Question

You are working on a drug called Cerebrolysin, (CBL) which is a mixture of peptides that have been shown to treat Alzheimer's disease in mice. You have just finished the preclinical trials and are about to submit your regulatory filings to the FDA when your biggest investor asks for a progress report. They request 2 things. First, explain the steps you have taken in regards to coming up with your product and preclinical trials in animal models and what filing you are about to submit. Then explain the 3 parts of the clinical trials and why you may (or may not) be able to combine the steps of the trials and what filings you have to do when you are done with the trials. 200 WORDS

Explanation / Answer

Three parts of clinical trials are as follows:

Phase 1 trials: At this stage the experimental study is conducted on the drugs such as checking the performance of the drug based on laboratory techniques and experimental data are used for approval of the second stage of the drug trial.

Phase 2 trials: Are generally done on mouse model which is considered as standard model oragansim for drug trials. Here clinical trials are conducted on animals by comparison study of the performance of the drug on a group of animals who were treated with the drug with the animals group who didn't received any doses. Such data's are helpful for clinical trials approval for testing of the drug on humans.

Phase 3 trials: This can be considered a important stage where finally you are ready to test your drug after successful result of the above two trials. In this study a small group of people are not provided with any drug doses and for the comparison of your drug molecule a small group of people were treated with the drug that you are studing it. A trial study at this phase is conducted and several parameters are studied here until the result shows satisfaction of positive results.

Clinically the above trial period of drug molecule testing takes a period of 10-15 years until it is ready to be launch and tested on large group of people. The steps of the trial cannot be combined together because each step requires a through study and holds an importance for the checking of the integrity of the drug. A drug molecule can fail at any stage any requires modification based on the analysis that is done. After successful finishing the drug and even getting approval for it from FDA I can apply for the patent of the drug molecule or can wait for the market performance of the drug on large group of people. Knowing drug adverse effects as well as performance of the drug on different group of ethnic populaton is also significant.

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