The Process of Getting New Drugs Approved in the United States

For the last 20 years, Robert Gadimian, has worked in the drug development and regulation sector, helping pharmaceutical companies get their products approved. In the United States, pharmaceutical companies must have their products approved by the FDA, and Robert Gadimian is extremely experienced with FDA guidelines.

The process for FDA approval involves five stages. The stages are as follows: discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring.

The first thing a pharmaceutical company does is conduct laboratory tests. Then, the drug is carefully tested on – first on animals and then on human subjects. Afterward, FDA scientists review the research and guidelines the pharmaceutical company has compiled on how the drug will be used. The FDA’s goal is to determine whether the drug’s risks are higher than its potential benefits. They also verify that the drug can be manufactured in a way that ensures quality and safety. When the pharmaceutical company fulfills these conditions, the FDA allows the drug to be manufactured and marketed in the United States.

After production, the FDA continues to monitor the drug to make sure it does not cause health hazards.

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How Cystic Fibrosis Can Be Treated

President of the Burbank, California firm Perceptive-Regulatory Consulting the Robert Gadimian is an authority in pharmaceutical research. Also the leader of Rophe Pharma, presently, Robert Gadimian is working on a patent related to novel compounds that treat cystic fibrosis.

Cystic fibrosis is a hereditary illness that does not have a cure. However, there are ways to at least manage symptoms. Primarily, the disease affects the exocrine glands, causing the production of extremely thick mucus and leading to the blockage of some of the respiratory organs. Hence, one way to treat cystic fibrosis is to take medication to improve the function of these organs. These medications include antibiotics to tackle the respiratory infections that the disease may cause.

Another treatment approach is cystic fibrosis is pulmonary rehabilitation. This involves exercise, breathing techniques, nutritional advice, counseling, and education. Pulmonary rehabilitation is used to treat people with chronic respiratory diseases, and cystic fibrosis is no exception. Physical activity helps to clear the “frozen” mucus in the lungs, resulting in better breathing and, generally, better health.

Finally, there a few surgical procedures that can help in treating cystic fibrosis. They include nasal and sinus surgery, bowel surgery, lung transplant, and liver transplant.

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Drugs for Life-Threatening Diseases

An accomplished regulatory consultant with more than two decades of experience working at pharmaceutical and biotechnology companies, Robert Gadimian leads Perspective Regulatory Consulting as president. In this position, Robert Gadimian is responsible for guiding the development team in terms of the regulatory requirements for the development of new drugs.

During the manufacturing process of drugs, there are chances that potential genotoxic (DNA-damaging) compounds are added to the synthetic reaction in the initial phase or formed subsequently as potential genotoxic impurities (PGI). This is a common issue with the manufacturing of drugs that are based on small molecules. To counter PGI issues, almost all companies involved in the manufacturing of small-molecule compounds run tests to check for potentially genotoxic impurities. If the drug in question is designed to treat a life-threatening disease or the patients who are to use the drugs are not expected to live more than five years, PGI is of less consequence and requires less attention.

The main reason for evaluating PGI risk is to mitigate the chances of developing cancer as a result of consuming genotoxic impurities along with medication over a long period of time. Since patients with life-threatening diseases are much less likely to consume the drug for a long time, their chances of developing cancer from genotoxic impurities are significantly lower. In addition, some of the patients are already cancer patients, which makes the genotoxic impurities incapable of causing a new cancer.

Common Causes of Acne

An independent regulatory affairs consultant with 20 years of experience working in the pharmaceutical industry, Robert Gadimian serves as president of Perceptive Regulatory Consulting, California. Robert Gadimian is actively involved in supplement research for common skin problems like acne.

Acne is a skin problem that can present with whiteheads, blackheads, rashes, inflammation, and sometimes deep lesions in some areas of the skin where oil-producing glands can be found. Acne can be mild, moderate, or severe. In severe acne, a person can suffer permanent scarring of the skin, which may be embarrassing. Generally, multiple factors play an important role in a person’s susceptibility to acne. These include:

1. Genetic predisposition – Genes can contribute to an assortment of factors that can cause acne or a person’s susceptibility to it. For instance, hormones, which are products of genes, can play an important role in acne formation.

2. Hormones – Significant or rapid hormonal fluctuation can cause acne. While this is common during adolescence (where sex hormones boost rapidly), women who are pregnant, in premenopause, or using hormonal birth control can have rapid hormonal fluctuation.

3. Follicular hyperkeratinization – Follicular hyperkeratinization refers to the abnormal shedding of skin cells near pores’ openings. When this occurs, the cells may clog the pore and get inflamed by oils and other substances that otherwise would have been excreted through the opening.

4. Bacteria – Propionibacterium acnes, a bacterium, can grow abnormally on the skin and cause inflammation and skin damage – acne. It can also trigger other acne risk factors like follicular hyperkeratinization.

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