Preclinical 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.

Before getting marketing approval for any drug in United States it has to pass through FDA review process. Under prescription Drug User Act (PDUFA) came in effect in 1992, FDA has set up specific goals to improve drug review process time and created two tiered system of review times. The standard review and The Priority Review.

In the past, no regulations existed to protect the public from dangerous drugs. To obtain permission to market a drug, the manufacturer must satisfy the Food and Drug Administration that the drug is both safe and effective. FDA approval requires clinical trials to determine both safety and efficacy and can take a decade or more.

9.11.The U.S.Food and Drug Administration(FDA) is responsible for approving new drugs.Many consumer groups feel that the approval process is too easy and,therefore,too many drugs are approved that

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,

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. This authorization should be acquired before the start of interstate commerce of the product. During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified capable for further development, the sponsor starts collecting the data and information necessary to establish that the product will be safe

Prior to the amendments, only safety of the drug needed to be proven to be approved by FDA. The amendments now required new drugs to show efficiency as well as safety--which means drugs need to show that their benefits outweigh risks in order to be approved. The three phases of clinical trials were now done to prove the drug’s safety and efficiency--phase I trials typically assess data on safety; phase II trials evaluate efficacy; and phase III trials compare the potential drug with standard therapy, usually on a randomized, double-blind basis (Jonsen & Stryker, 1993).

The first phase is to find any extreme and dangerous side effects of the drugs. In this phase, researchers use healthy volunteers or patients with diseases. During this phase, the researchers are also trying to find out the drug is metabolized and expelled from the body. Phase two is trying to determine the effectiveness of the drug on a patient. During this stage, researchers add different drugs or a placebo to see how well the new intervention works. Phase three is continuing to determine its effectiveness and how safe it is. There are changes of doses and different population in this phase. The fourth stage happens after the study is approved by the FDA. In this stage, the drug is allowed to be marketed, but the researchers are required to continue finding information about its safety, effectiveness, and what it should be used

There are three phases of testing, a drug must go though to be approved by the FDA, before it can be sold to the

“The sponsor of a drug for a serious condition may request that the FDA agree to an accelerated approval development plan. The plan must include the design of the drug study.”(1)

for marketing in the United States. Before a drug is approved for sale, it must go through several phases of drug

Trials are complete and approved by the FDA. To make this possible, steps must be taken to have the phase 3 trials completed in the US and approval obtained by the FDA. Market research could then be conducted comparing the effects of the drug compared to other drugs on the market.

The main purpose of clinical trails is to grasp a clear understanding of drugs relation with the human body. First, the drug company would conduct an Investigational New Drugs Process for the review board of the FDA to approve (FDA, 2014). About fifty to one hundred healthy volunteers would study the drug and monitor for any interaction and dosing only if the body can tolerate it, focusing mainly on the side effects. Second, phase two would have sick patients to be studied for many months up to two years or longer to see the therapeutic effects of the drugs (FDA, 2014). Next, phase three which could take one to four years to complete. The huge number of patients, it is crucial because these pivotal trails done by researcher would assist in determine if the new drug can be a viable treatment and benefit to the growing disease population. Now that all the clinical trails are done, the drug company can file a New Drug Application to the FDA for review and approval. Last, the new drug will go to the market. The drug company must still provide the FDA with data, studies, and analyses for the FDA to review the new drug. If the new drug is viewed to be safe by the FDA, the new drug will be approved and advance to the next stage of which is labeling (FDA, 2014). For example, a Zantac tablet, known as ranitidine is

Each drug then had to pass the following three phases of clinical trials under the U.S. Food and Drug Administration:

Pre-clinical testing is performed to Good laboratory practice (GLP) and covers pivotal toxicology & safety pharmacology studies. In preclinical research, scientists test their ideas for new biomedical prevention strategies in laboratory experiments or in animals.