Non Clinical Studies : The Discovery Of A 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.

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?

During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.

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

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).

If the medicinal chemists could synthesize the drugs that I would use for future experimentation, and assuming there is no limit to my funding, I would conduct experiments that would determine the pharmacokinetics, the pharmacodynamics, the

The published research about the impact of over-the-counter non-prescription drug advertising is very limited. Most of published research articles already focused on impact of drug advertising on prescription drugs due to incredible development of prescription drug’s advertising starting from the year of 1997. The main reason is slacking of FDA’s regulation on drug’s advertising session (DeLorme et al, 2010; Huh & Becker, 2005).

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.

Experimental Therapeutics & Pathophysiology Branch (ETPB) and Section on

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.

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

Many drugs, medicines, and operations that could benefit humans may never be discovered, for they produced no diagnosis in animal tests. Although drugs that fail in animal experiments rarely appear tested on humans, there have been a few evident cases determined. For example, while Lipitor did not appear promising in early stages of animal testing, a research scientist requested that a small group of healthy human volunteers tested the drug, and only then was it found effective and useful. “In many instances, medical discoveries are delayed as researchers vainly waste time, money, effort, and animal lives trying to create an animal model of a human disease” (Aavs).

It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.

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