How Prescriptions Evolve: 4 Stages to Major Pharmaceutical Development

 

Millions and millions of people take prescription drugs every day, but few actually think about where they come from or the steps that it takes to make these medicines available. There are four steps in the development of pharmaceuticals; these include three initial phases and finally an approval by the FDA. The entire process takes between eight to 12 years.

 

1. Preclinical Phase

In the preclinical phase, the goal is to find an agent that can be used to treat a certain disease or condition. This involves three to four years of research, the synthesizing of compounds, the testing of those compounds in a non-clinical setting with the help of companies like Nelson Laboratories, and, often, computer simulations on how the new investigational drug may help to slow the progression of a disease or treat its symptoms.

 

2. Application to the FDA for Investigational Drug

If the preclinical phase is deemed successful, meaning that the compound is promising and shows an ability to treat a disease or ailment, then an application to the FDA as a new investigational drug is in order. The time it takes for the FDA to approve or deny the investigational drug trials varies, but may take up to a year.

 

3. Clinical Phases 1, 2 and 3

There are three clinical phases for all investigational drugs, and they must be tested on animals prior to their introduction to the human population. After animal (usually rodent) testing is completed, the three clinical phases for humans include:

• Phase 1 – Investigational drug is given in small doses to volunteers who are healthy in order to test its pharmacology and safety.


• Phase 2 – The efficacy of the investigational drug is studied. This involves a clinical trial with 100 to 300 patients who have the condition that the drug is designed to treat.


• Phase 3 – The drug is given to a larger population in an attempt to back up safety and efficacy findings and to titrate the right dosage.

These phases take one, two and three years, respectively. It should be mentioned that nearly half of the medications submitted to the FDA for investigational drugs will fail in the clinical phases.

 

4. New Drug Application with FDA

Finally, if the drug passes through all of the clinical phases, the manufacturer will submit an application for a new drug. The FDA will complete its own review at this point, and since 1992, the FDA has worked to complete these reviews in 12 months or less. Sometimes, drugs are denied; in other cases, the drugs may be approved conditionally. The manufacturer is required to keep track of results for the first three years after approval and report adverse reactions quarterly.

 

Because of the processes involved in developing new drugs and getting them approved through the FDA, these medications can often be quite expensive. A vast amount of research and testing must be done long before these drugs are available to consumers.

Categories: clinical, clinical phase, clinical phases, Drug, drugs, fda, investigational, investigational drug, investigational drugs, New Drug, pharmaceuticals, phases, preclinical phase

Are Clinical Trials Safe? 5 things To Know Before You Sign Up

Clinical trials can be a good way of making a few extra dollars. However, many people wonder if the trials are safe, so they are hesitant to participate. Safety can vary between trials depending on the clinic that is holding the trial, the qualification of the staff, what the trial is testing, what medication is used, etc. However, there are a few things to know about clinical trials in general before you commit. It is important to thoroughly research the trial you intend to participate in, but here are a few things you should know before signing up for a clinical trial anywhere.

You’re Not the First Test

Clinical trials are made safer by extensive research prior to administration to humans as well as animal trials on animals that have a similar genetic makeup to humans. Researchers are extremely confident of the drug’s efficacy and lack of serious side effects before they begin conducting clinical trials on humans. If any of your findings suggest that you are the first group to try a new drug or treatment, find out what that really means. Try to find out how extensively the clinic has tested the treatments before they plan to test them out on you.

Liability is High

The value of human lives is high for researchers, and any problems with the clinical trials could mean millions of dollars in payouts to the participants. So you can be sure that researchers will take all of the safeguards necessary to prevent possible injury or side effects. Because of the liability involved in clinical trials, they are not just thrown together (for the most part.) They take careful planning and are meant to benefit people, not put human lives in danger. Because of liability issues, the clinic you choose should have a highly skilled staff of individuals who know what they are doing. They will use a high grade of medical devices, even for small things like syringes, a Luer Lock, needles, and other instruments. Any legitimate clinical trial will have a professional staff, adequate equipment, and high confidence in the success of the trial and safety of the patients.

You Will Be Monitored Carefully

Researchers will be sure to monitor their clinical trial participants very carefully for any signs that the drug is having an unintended effect. Your health, vitals, experiences, and symptoms will be of great importance. Any signs of trouble will mean that the trials will be stopped, and the symptoms will be treated carefully. Those holding the trial will be sure to give you explicit instructions of what to do if you experience any abnormal symptoms, and prepare you for anything that could go wrong. They should also provide you with contact information you can use either for an urgent situation, or just for any questions or concerns you may have. They will want to communicate with you as thoroughly and frequently as possible, not only to monitor your status, but to make sure that nothing is out of the ordinary or endangering your life in any way.

You Are Not Obligated to Continue

If at any time during a trial you feel that you would not like to continue, you are able to quit taking the medication and end the trial. So you can feel safe in knowing that you will not be obligated to continue a trial if you think that you may be experiencing negative symptoms from the medication. However, your health will still be monitored for a certain period, even if you choose to end the trial. In most cases, you will still get paid and won’t be penalized for ending the trial early. The clinic will want you to end the trial if it is putting your life and health at risk, so you will likely still receive compensation for the part of the trial that you participated in.

There are Various Levels of Safety

As mentioned before, the level of safety of the test depends on many factors. For instance, it could be considered a “safer” trial depending on how many trials have been conducted with the medication before. If you are in the fourth round of human trials, and the first three have gone successfully, then you can be fairly confident that you will be safe. It will also depend on what the trial is testing, like what diseases or body parts are the main focus of the trial. This is where your judgment comes into play. It is up to you to do the research necessary to decide if a particular trial is right for you. After weighing the pros and cons of a study, you can decide if it is worth your time, the amount of money offered, and the risk to your personal health.

 

Clinical trials do have their risks, but companies and researchers have a lot of interest in making sure that the drugs are safe before they administer them to people. The public backlash, human cost, and moral concerns make it certain that the clinical trials will be well monitored. Most clinical trials are very safe, and there is a lot of effort put into making the trials as safe as possible.

Categories: clinical, Safe, trial

The Big C: Why this Vitamin is Vital for Staying Young

When you think of the wellness benefits of vitamin C, your imagination probably stretches as far as scurvy, and the common cold. As the former really isn’t so much of a problem in modern day Britain, and the latter probably isn’t going to properly threaten your wellbeing, this makes vitamin C rather, well, insignificant, doesn’t it? However, this is an unfair judgement to pass on vitamin C, as scientists have taken a fresh look at the nutrient, and deemed it a vital vitamin for your anti-ageing wellness, as well as helping you stay healthy. Here’s why:

 

1. C away those wrinkles: There’s not a beauty product around that doesn’t have an ingredient list filled to the brim with antioxidants. The reason for this is that antioxidants (including vitamin C) can help you to turn back the clock on your wrinkles. According to an October 2007 study, published in the American Journal of Clinical Nutrition, if you eat vitamin C-rich foods, you’re less likely to have wrinkles and age-related dry skin than those whose diets contain only small amounts of the vitamin. Patricia Farris, MD, clinical assistant professor of dermatology at Tulane University in New Orleans, explains, ‘Vitamin C does some repair and firming on the skin.’

 

2. C that heart protected: While the wellness debate continues over the true effectiveness of vitamin C in preventing heart disease, the evidence on the “pro” side is pretty convincing. A Finnish study found that taking more than 700mg of C supplements daily reduces your risk of cardiovascular disease by 25%, while Harvard University researchers found that women who take 500mg of vitamin C combined with 600IU of other antioxidant vitamin E can cut their risk of stroke by 30%.

 

3. C off the Big C: A diet full of vitamin C–rich fruits and vegetables may lower your risks of bladder, oesophagus, stomach, and lung cancers. Again, we need more research in this area to find out an exact cause-and-effect, but the association between vitamin C and cancer prevention – and even cancer treatment – is strong. Mark Levine, MD, chief of the molecular and clinical nutrition section and senior staff physician at the National Institutes of Health, advises, ‘Strive for five or more fruits and vegetables daily, in a rainbow of colours; its where the most benefit is.’

 

4. C your brain power boosted: Again, pairing up vitamins C and E (at 500mg and 400IU, respectively) is beneficial to your health, this time because it may lessen your risk of Alzheimer’s by 64%, research in the Archives of Neurology has shown. Study author Peter Zandi, PhD, an assistant professor at Johns Hopkins University Bloomberg School of Public Health, notes, ‘Some studies suggest that vitamin E does its job reducing free radicals in the body, but then its capacity is depleted. Vitamin C may recharge E.’

 

5. C more: Not only can vitamin C delay your need for reading glasses as you age, it can also help prevent age-related macular degeneration (AMD) which is one of the leading causes of blindness. The National Eye Institute recently sponsored a clinical trial which showed that a daily supplement of 500mg vitamin C, 400IU vitamin E, 15mg beta-carotene, 80mg zinc, and 2mg copper reduced moderate or severe AMD by up to 25%.

 

6. C yourself into old age: You may have heard that green tea boosts your body’s defences against toxins, preventing cancer, heart attack, stroke, and lots of other maladies, but citrus juices (such as lemon, lime, orange) may supercharge the immunity-boosting power of green tea. A study led by Mario G. Ferruzzi, PhD, assistant professor in Purdue University’s department of food and nutrition, found that mixing citrus juice with green tea enabled 80% of the tea’s anti-oxidants to stick around after simulated digestion.

Categories: age related, assistant professor, cancer, clinical, clinical nutrition, green tea, nbsp, study, university, vitamin, vitamin c, Wrinkles