The Discovery Of New Drug Without Involving Human Subjects

The discovery process is the preliminary research that an organization or research team will engage in before they even begin to look at a new drug on a molecular level. “The discovery process includes the early phases of research, which are designed to identify an investigational drug and perform initial tests in the lab” (PhRMA, 2015). In order for the researchers to know where to start with trying to create a new cure or treatment, they first have to do an in depth analysis of the disease so that they can fully understand it.

There are four stages for a new drug to be approved by the FDA. The first stage is pre-clinical investigation. During this stage, researchers need to find out if a new drug can cause harm to people before testing it. There are two types of preclinical research. They are In Vitro and In Vivo. Preclinical studies are not very big. These studies give information on dosing and the poisonous levels. The researchers read over what they found and make a decision on whether the drug should be tested.

A. Is it ethical or unethical to use animals, such as rodents, as a model to test the effects of new drugs? New medications are constantly made to help patients in need but what happens if a computer model doesn’t show the positive and negative effects that new drug can have? What alternative options do those making new medication have instead of animal testing?

1. first by the conditions that they are used to treat, and then by their mechanisms of action

The first phase pertains to the initial investigation of a new human drug. These studies are monitored

The first step in developing a drug is pre-clinical testing. The experimental drug is tested in a laboratory and in animal studies. The drug has to meet safety standards and show potential for being a new drug. If this criterion is met, the drug moves on to the next phase. Phase 1 is concentrated on making sure the drug is safe to use on humans. This is the first time the experimental drug is used on people. Different measures of dosages of the drug are given to a small number of the volunteers. This allows the researchers to be able to measure the body’s response to the drug. The things they measure include how the drug is absorbed, its duration in the bloodstream, and what dosage levels are safe and well accepted by the body. If the experimental drug is deemed safe, it passes on to Phase 2 (Phases of Development, par. 6-7).

a.) Evaluating the potential risks and benefits of the medication since there can be adverse events since there isn’t the proof of safety and efficacy. But the patient’s condition demands every possible medication that can be used for treatment.

Now to finally address the experimental issues of this study that the experimenters need to address before their new drug can be put into production and distributed. The first experimental issue of this study was that it did not use random assignment. The participants were placed in either the treatment group or the placebo group by the researcher so they did not have the same chance of

Recent working experience for 21 months as a study coordinator at the cancer centre of Seoul National University Hospital has given me a greater passion for expanding my career of proficiency and growing my expertise in pharmaceutical research area. This experience also led to me learning much about not only the patients journey from diagnosis to chemo/radiotherapy but also whole process of clinical trials. I am familiar with a clinical trial protocol,

Research in biomedical science has generated a wealth of new discoveries that are improving our health, extending our lives, and raising our standard of living. In order to assist this process there has to be testing on animals and humans in clinical trials. Many people think that clinical trials are inhumane and harmful to humans and animals; however, there are many benefits to participating in clinical trials. Clinical trials help determine when new medicines should be put on the market, they help discover new cures for disease, are safe, confidential, and could save millions of lives.

(WY Mak et. Al, 2014) discusses the concerns of the fact that many drugs that are successful in animal trials are not successful in clinical trials, most specifically, drugs used in cancer treatments. Animal models have been an important factor in the testing of a new drug before it is used in clinical trials, but many drugs that are approved in animal models are not successful in human models. It has been shown that 85% of early clinical trials for novel drugs are not successful and from the remaining 15%, only half are approved for human use. The reason there is a difference in results between animal models and clinical trials have to do with the inability of animals to identically mimic human body functions. An example of a trial that had a difference in results is the TGN1412 trial. TGN1412 was a drug used to treat diseases such as MS, rheumatoid arthritis, and certain cancers. Before used in clinical trials, this drug was first tested in mice. There were no complications shown in mice that would indicate complications in humans. Humans in clinical trials were given a dose 500 times lower than the dose given to mice and it resulted in catastrophic organ failure. Another study involving IPI-296 in patients with advanced chondrosarcoma was ended early due to the fact that it had no effect shown in clinical trials. When IPI-296 was used on mice, they were shown to have an increase in survival rate. This showed that the effects of the drug on animal models was different

Drug trials may likewise be utilized to figure out if a current drug can be securely and adequately utilized for different sicknesses and/or conditions.

The stages of pharmacovigilance coincide with the stages of clinical trials. Each stage of a clinical trial has a pharmacovigilant component. The preclinical phase which is restricted to animal testing is the first stage of research and development that determines safety. Once a compound is determined to be safe in laboratory animals and has potential to be therapeutic in humans, it can be considered for Clinical Trials. Phase 1 of a clinical trial is primarily to evaluate a new compound’s safety in general and therefore is conducted with less than 100 participants which are expected to be healthy. If the Phase 1 safety profile suggests a low risk factor for a drug, Phase 2 and 3 studies continue with the

As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008).

Drug research is connected to a range of academic studies such as biology, pharmacology, medicinal chemistry and toxicology. Pharmaceutical researchers can design novel therapeutic drugs based on these studies above. The invention of new drug can be divided by function into two stages: drug discovery and drug development. Drug discovery is the process by which a new drug candidate is found and identified. Distinctively, bringing a new drug candidate to the market through clinical trials is called drug development. The first part of this essay provides an overview of drug discovery and pre-clinical research and development