The Drug Development And Approval Process

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.

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

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

How do they extrapolate their findings from preclinical animal studies to relate to the intended human population (IND application & IND amendments FDA1571/FDA1572 & entire NDA application)? As the experimental drug activity is established in animal models, how do the results of these preclinical animal trials determine whether the drug appears to be safe and show promise of effectiveness in humans and warrants human clinical trials with the experimental drug.

The beginning phase known as phase 0 includes the exploration of how a new drug may work. Phase 0 isn’t necessarily harmful to the experimental patient but worthwhile in the end due to the benefits and possible efficacy that the later trials may prove. Phase 0 also includes the dosing factor. The dosing factor is in intermittent low doses and this is why phase 0 is precedent to phase one. “The biggest difference between phase 0 and the later phases of clinical trials is that there’s almost no chance the volunteer will benefit by taking part in a phase 0 trial – the benefit will be for other people in the future. Because drug doses are low, there’s also less risk to the patient in phase 0 studies compared to phase I studies.”(“What are the Phases of Clinical Trials”). Phase one includes the regulation and experimentation of smaller higher doses of an experimental drug that could possibly be used as a cure for a terminally ill patient. Phase one includes a few factors that sum up the highest potential risks of all phases of a clinical trial. Those factors include the following: having a handful of experimental patients to start the medication at small higher doses, not forgetting to watch for harmful side effects.

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).

One contributing factor is the cost of research and development required to bring a new drug to market. In order to be approved by the FDA, a drug must go through phase 0, I, II, and III processes. Phase 0 involves animal testing, phase I is small scale clinical studies to determine safety, phase II is clinical studies to determine effectiveness,

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

When I was a kid, I always wondered why it took so long for an ill person to become well again. I always thought that if the ill person went to the doctor they would be back to normal the next day, but that’s not the case. For some people it took several days, weeks, months, and even years to conquer an illness but as a child I never could understand that. I don’t know how many times I’ve asked my mom or dad how come the doctors don’t get together and make a “miracle” drug that could heal anything and everything. It wasn’t until the age of 15 when my grandmother was diagnosed with breast cancer that I understood why it took so long for others to heal and the process that they had to endure in order to be healthy again. Shortly after my grandmother’s diagnosis, I started looking into what it would take to get a drug that would cure cancer through the approval process on the shelf to save some many others just like my grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards chemotherapy and radiation. Although I wanted something to heal my grandmother fast, chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high school. I went to almost every appointment with her to watch how it helped strengthen but also watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my

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.

Who Enrolls in Drug Trials? Healthy experienced testers are used during Phase I where the side effects and safety of a potential new drug are tested. Phase II trials find dosing requirements and therapeutic efficiency. Phase III trials are on a much larger scale so they can compare the results with other medications on the market. Experimental drugs, biologics, and devices are just a few of the studies these “guinea pigs” can participate done.

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’.

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;

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

ISSN: 2277- 7695 TPI 2014; 3(7): 08-12 © 2013 TPI www.thepharmajournal.com Received: 14-08-2014 Accepted: 28-08-2014 Rizwan Raheem Ahmed Professor, Department of Business Administration & Commerce Indus University, Pakistan