Animal Testing Process Essay

Physicians must prove that there is no other comparable or satisfactory alternative in order to diagnose, monitor, or treat their patient’s condition or disease. They must also conclude that the potential risk of the product is not greater than the risk of the disease or condition (Expanded Access 1). The FDA must also determine that here have been enough tests done already to provide sufficient evidence as to the safety and effectiveness of the product and its use in the case (Expanded Access 1). In addition, the FDA must also be certain that by providing this product to patients outside of the clinical trial it will not interfere with the clinical trial, and the FDA acceptance of the drug (Expanded Access 1). Another requirement is that the company developing the pharmaceutical product, or the clinical investigator, submits a treatment plan (clinical protocol) for the patient, which must follow the FDA’s regulations for INDs (Investigational New Drug) or IDEs (Investigational Device Exemption Application), which describe the use of the investigational product (Expanded Access 1). Pharmaceutical companies must also submit a draft of the Data Development Plan (Expedited Access Pathway Program).

There are several phases and applications to complete for drug development in the United States. The three basic stages in the testing process are preclinical, clinical, and approval. The first step of preclinical usually lasts anywhere from one to six years. During the preclinical phase, toxicology studies on the ingredients are collected and drug testing

Typically, there is a small number of people used in these Phase I trials, between 20 and 80. Phase II trials have more participants(100-300) who have the condition or disease that the product may be able to treat. Researchers want to gather further safety data and preliminary evidence of the drug’s beneficial effects, and they develop and refine research methods for future trials with this drug. If the drug is indicated to possibly be effective during Phase II, given the observed severity of the disease, the drug will progress to Phase III. In Phase III, the drug is studied in a larger number of people with the disease, between 1,000-3,000 usually. The phase further tests the product’s effectiveness, monitors side effects and, in can compare the product’s effects to a standard treatment, if one is available already. Having more participants reveals the less common side effects. Phase II and Phase III clinical trials typically involve a “control” standard. One group is given the drug and the control group is given either a standard treatment for the illness or a placebo. Phase IV is the part of the trial that is sometimes conducted after a product is already approved and on the market. The purpose is to find out more about the treatment’s long-term risks, optimal use, and benefits, or to test the product in different demographics, such as children. Informed consent is the process by which potential participants for a study are given complete information about the study. The informed consent process provides an opportunity for the researcher and patient to exchange information and ask questions. Patients are invited to enter a trial but are not forced to do so. They can consent to participate if they find the potential risks and benefits acceptable. A participant must sign a consent form prior to enrolling in a study before

During this phase the drug is considered and the talk of different dosage, patients and longevity of use is looked over. After phase three the drug is written up again in as a new drug application and is filed to the FDA in which they have 60 days to review and submit in order for this drug to get out. Following there are different steps of approval determining the severity of need for the drug and its underlying benefits. In most cases it will take some time and scrutinizing of the FDA’s review team before the drug can be released, but under certain circumstances drugs may be approved for release without the sponsors showing its safety and true effectiveness. This process is called “accelerated approval” in which if there are very few cures for a certain disease or none at all then a drug can be approved for use, it will be reviewed and possibly withdrawn but just the act of allowing such a thing to occur yet again should not sit well with most. The most recent example of this would be studies shown of Chronic Myeloid Leukemia in which they released a drug that barely passed phase two. They call it in these dire circumstances a “surrogate endpoint” almost as if the patient is already dying so the outcome, good or bad is ok as long as they see the effectiveness of this drug. In concluding the process of review it appears that there is a great system of checks and balances and a great deal of care put in to the

Once a new drug application is filed, an FDA review team evaluates whether the studies

During preclinical drug development, the pharmaceutical company or drug sponsor must determine if the product is viable for human uses. The sponsor must test the new drug on multiple species of animals in vivo and in vitro to assess the drug toxicity and pharmacologic effects. Animal studies could take 2 weeks to 3 months to collect basic information about the safety and efficacy of the drug.

months.12 FDA reviews the drugs in 60 days (Fast track) that intended to treat serious or lifethreatening

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

It is no secret that millions of animals a year are used for medical experimentation. One study “found the number of animals tested rose from 1,566,994 in 1997 to 2,705,772 in 2012” (Casey). It is my belief that researchers use virtue theory to defend their experimentations. While animal activists approach experimentation through the ethics of care. I am against animal experimentation, but I will also provide insight into why people believe it is ethically just.

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

The U.S. Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical devices in the context of granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, and post-marketing surveillance of the medical product. Pharmaceutical companies seek FDA approval for a new drug to be marketed which entails a long process. This process starts with submitting an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that the drug is safe and effective.

These stages include drug development, synthesis, animal testing, human clinical trials, and an FDA submission for possible drug approval. R&D costs fluctuate depending on the stage of drug development (Golec, Hegde and Vernon 2010). At the early stages, R&D costs are low and a company could end an R&D project relatively quickly; however, clinical trials have high R&D costs and companies are less likely to end a project at this stage (Golec, Hegde and Vernon 2010). The closer to the end of the project, costs are very small and companies are less likely to end a project in its final stage (Golec, Hegde and Vernon 2010).

Critics argue that researching and testing on animals is necessary as it leads to many medical advances and breakthroughs. Some medical advances that have resulted from animal testing include blood transfusions, insulin, antibiotics, asthma medicine, vaccines, transplants, numerous drugs, Parkinson’s disease, and chemotherapy. Although new valuable information has been gained from animal research, times have changed and there are now more humane ways to do research. In Vitro testing, computer modeling, and human-patient simulators are some of the alternative methods that can replace animal testing. In Vitro methods use human cells and tissues to study diseases and test products. There are two types of In Vitro methods: Organ on chips and 3-D printing human skin. Organ on

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;

“Beauty without cruelty” is the outcry that can be heard from animal right activists around the world. The FDA does not require companies to perform tests on animals but if the cosmetic product contains chemicals that can be seen as toxins, testing becomes a necessity. There are currently thirteen safety tests that are performed on animals.