The Drug Development And Approval Process

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.

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.

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.

To start, the results of animal testing cannot be accurately assumed safe for human use. In 1960 an organisation known as Animal Friends Croatia created a drug called Thalidomide which eased morning sickness for pregnant women. Before being sold to the public, it was tested on multiple different types of species and was

The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” ("What We Do."). One of the most important responsibilities and the topic I will be discussing throughout this paper is drug regulation. The Food and Drug Administration approves drugs that are intended for use in diagnosis, cure, relief, treatment, or prevention of disease, and is intended to affect the function of the body. In order to do so, The Food and Drug Administration reviews drug manufacturer’s via application to put drugs on the market; therefore, a drug may not be sold or marketed unless it has and remains approved by the FDA. Even though a drug has been approved does not mean it will remain on the market, drugs have the likelihood to be recalled. For example, when you see those late night personal injury lawyer commercials saying, “If you have been prescribed and taken said drug, and experienced any of these side effects such as blood clots, seizures, etc., you may be entitled to compensation.” those drugs have usually been recalled due to adverse effects

Each and every member of the team will understand the science behind the clinical trial provides significant background for the tasks that will be allocated and related decisions will be considered. We will take help from medical monitor or other suitable expert to arrange an outline of the therapeutic part and sign, to talk about the specific mechanisms pertinent to the manufactured goods being evaluated, and to talk about earlier and rival trials that may offer context to our

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

There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary 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.

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

One of the first parts of any drug development process is to identify a compound with the potential to become a commercial drug. Drugs for which the a 505(b)2 pathway are being considered are no different. As such, pharmaceutical executives should research the market; conduct an analysis of the strengths, weaknesses, opportunities, and threats posed by a product; investigate the requirements for production; investigate a compound 's attractiveness to investors; and determine whether such a product would be profitable to develop.

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’.

Preclinical testing begins with identifying the ideal drug target. The target should be disease-modifying and/or have a proven function in the pathophysiology of the disease. Target expression should not be uniformly distributed throughout the body. There should also be a

The various lead compounds can be initially tested and virtual screened by high-throughput screenings (HTS) to evaluate their properties in biochemical reactions, and then the lead compounds will be optimized through altering their molecular structure. Several physicochemical properties and pharmacokinetics properties of the lead compounds will be established, such as lipophilicity, solubility, ionization, molecular size and H-bonding. The process of lead optimization can not only improves lead compounds’ physicochemical properties, but also makes them more effective and safer. Simultaneously, medicinal chemists begin to consider about chemical manufacture and control (CMC), such as synthesis, formulation, delivery mechanism and large-scale manufacturing. The optimized lead compound could ultimately evolve into a new drug candidate. The function of pre-clinical research is to assess all of the physicochemical and pharmacokinetics parameters prior to clinical trials. Or, to put it another way, whether the lead compound is safe enough to move on to clinical trials depends on pre-clinical research. For example, pharmaceutical researchers carry out pharmacokinetics (PK) testing which involves absorption, distribution, metabolism, excretion (ADME), and toxicology to estimate the safety starting dose through in vitro and in vivo testing. After these complicated and rigorous pre-clinical trials, scientists have

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