Drug approval process animal trials

It is of utmost importance that the scientific community acts according to ethical standards when clinical trials and animal tests are unavoidable. Implementation of biosimulation into the drug approval process is a great step towards this objective. 

Diet drugs that are in development take years to be approved and marketed in the United States. First, these compounds are studied in the laboratory. Then, they are tested in animals. The next step is to be tested in people. There are three rounds of study—called Phases 1,11, and III trials—to establish safety and effectiveness of the drug in humans. Drugs that are in Phase III trials are closest to approval and are usually available in the United States within a couple of years if they prove to be safe and effective. Drugs in Phase II trials are a little further behind in the approval process. 

Clinical Trial Application (CTA) has to be submitted to Health Canada seeking permission to conduct clinical trials. The submission should include information regarding drug characteristics, test data, animal studies, and clinical protocol. A clinical trial may be stopped when either it is shown to be unsafe or dramatic benefits are obtained. The approval process may be fast-tracked if a drug is shown to have substantial benefits, such as for treatment of life-threatening or severely debilitating conditions. 

Summary The summary presents the case for the drug s approval. It includes discussion about the drug s mechanism of action, its effect on animals, results of clinical trials, manufacturing and tests methods, its stability, and proposed dosage and treatment protocol. The summary may run into hundreds of pages. It is one of the few documents being read by all the different reviewers as such, a good summary will assist with the review process. 

Because proapproval testing affords only a limited view of a drug s benefits and risks, the research process usually does not stop at the point of market approval, Post-approval research can involve both clinical trials, referred to as Phase IV studies, and new animal toxicity studies (21 C.F.R. 310.303). 

By submitting the NDA application to the FDA, the sponsor formally proposes to approve a new drug for sale and marketing in the United States. The information on the drug s safety and efficacy collected during the animal and human trials during the IND process becomes part of the NDA application. The review process of the submitted NDA (Fig. 19.3) is expected to answer the following questions ... 

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