Assess The Goal Of Drug Development

1. Cost: The drug development is a lengthy and an expensive process. It will aid in the predevelopment process to identify future demand and to identify if it is a worthwhile venture. The future of a company could depend on the success or failure of a new drug in the market.

Michael Shally-Jensen writes about the role of animals in medical research and the procedures done in drug testing before it can be released in the market. Shally-Jensen talks about the involvement of the Food and Drug Administration (FDA) that requires animal testing as part of the licensing process. In Shally-Jensen’s article he also pointed out the alternatives available in research that can substitute the use of animals such as tissue cultured systems, artificial human skins, and computer models.

All drugs have dangers due to certain chemicals and substances. Because of animal testing, researchers have found another alternative to testing on humans.

After all, the FDA and the pharmaceutical industry prove that animal testing in drugs used by humans is unreliable. According to the FDA, 92% of drugs tested fail to meet the standards for human use. Animals do not share the same body system or physiological responses as humans, so why test these medication drugs on them? The National Anti-Vivisection Society states that it can be dangerous to apply animal-derived data to humans. Drugs that may be effective in animals may not be safe or effective in humans and vice versa. There are many examples where medications that worked on animals have proven to be dangerous to humans’ health. For example, the antibiotic, penicillin, was ineffective at treating infected rabbits and was toxic to guinea

Animal Testing is uncertain and hard. Animals go through a series of tests are very painful, most of the time they are not even given anything for pain. Some product tests require the same painful procedure on a daily basis over a weeks' time. Most tests on animals cause permanent injury or even death. The tests performed on animals are not always reliable. A medicine that may be safe with animals may not be for human beings. For example, aspirin is toxic to cats, so if we were to test this medication on cats, it would not help to determine if this was a safe product for human beings. One alternative to animal testing is human testing, if we are looking to find out if the product works on humans, we should test them on humans. That case "No

The author emphasizes in biological difference between human beings and animals meaning drugs safe for animals might not be safe for humans. It argues that the FDA should not mandate animal testing and should look to the alternative methods for evidence that supports drug approval. Author suggests many alternative methods other then animal testing that can make drugs more efficient and safe for human use, consequently saving animals from experimental cruelty which provides excellent quotations for the research paper.

The purpose of clinical development is to bring new drugs and therapies to patients. These drugs and therapies are studied and researched to be used for humans. Clinical development is very expensive and time consuming. The process of discovering a new drug, to having it approved for patient use, is approximately twelve years. The average cost to complete this process

Additionally, animals also undergo immense pain and trauma in the pursuit of results that are not directly applicable for human use. The Food and Drug Administration (FDA) in the U.S. has been using animals for testing to conclude that drugs and cosmetics are safe and effective before going into the human tests since the 1960s. These tests have been going on for

If animal testing is the best method for testing products, humans would be a good method as well. These drugs, whether they are cosmetic, house supplies, or food additives, are initially made for the human species. If none of the animals tested are going to have these products for personal use, they should not have to suffer for them. An alternative method of experimentation has been recently studied, this study showed that human tissue and human cells can be tested on rather than animals. "Human tissue- and cell-based research methods, cadavers, sophisticated high-fidelity human patient simulators and computational models are more reliable, more precise, less expensive, and more humane than animal experiments" (Animal Rights). Not only can

The drug approval process is a complicated labyrinth that sometimes seems impossible to navigate. There are guidelines, protocols, procedures and standards that each person in the process are expected to follow. This includes the doctors, principle investigators, researchers, pharmaceutical companies, the regulatory bodies and yes, the patients. The patients are by far the most important aspect of a clinical trial and obtaining drug approval. Without the willing volunteers in clinical trials there would not be treatments and cures for many diseases today. There are a lot of factors that go into getting a new medication to the open market, including many phases of clinical research. The roles of the FDA, various research laboratories and the pharmaceutical companies all play a pivotal role in the time that it takes to obtain drug approval. There are many obstacles associated with each step including funding and how that impacts the consumer costs.

Have you ever wondered about what a product or a medicine goes through before it gets to us on the store shelves? Products from deodorant to Viagra to weed killer go through years of tests before a regulating body decides they are safe for us to use. The FDA approves drugs and cosmetics and he EPA regulates chemicals that are used and may be harmful to the environment. However before these products are even considered by these regulatory bodies they must go through years of testing. Testing that is unfortunately done on defenseless animals. Each year 50 to 100 million vertebrate animals, such as mice, rats, rabbits, cats and dogs are used in experiments to test products such as medicines, lipstick, household cleaners and pesticides.

According to Professor Paul Furlong, “the anatomic, metabolic, and cellular between animals and people make animals poor models for human beings (Animal Testing - ProCon.org). This means that even though animals and humans are very similar, they are also very different. They have different cells that react to different chemicals and release different hormones than what it does to humans. Their bodies react differently to different tests. Maybe the company tests the product on a “dud” animal, and the product ends up killing the animal. And what if the animal dies later and the company thinks that the product is safe to put on the shelf? What if the product gets put on the shelf and ends up harming a bunch of people? Then the company will most likely get sued and they will probably go out of business. Which leads me to me second point is that even though a drug passes the animal test, doesn’t exactly mean that it’s safe for humans to use. In the 1950’s, there was this sleeping pill that basically killed 100,000 babies because the pill was tested on animals prior

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

Pharmaceutical sciences combine a broad range of scientific rules that are critical to the discovery and development of new therapies and drugs, and so in that saying, knowing this kind of information can help people around the world greatly in the future.