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

Warning: FDA Warns Against Using HCG For Weight Loss

Each year there is a new advance in the world of weight and fitness, a miracle drug that comes to light claiming to be the answer to every dieter’s dreams. Mostly these drugs turn out to be fairly useless, and sometimes they can even have the reverse effect and be damaging for your wellness and wellbeing.

 

Last year, the big thing has been for a certain homeopathic remedy which contains something called HCG. This stands for human chorionic gonadotropin, and is a hormone that is produced by pregnant women (usually found in the placenta). It has been used in the past to trigger ovulation in women who are undergoing treatment for fertility problems.

 

HCG can also allow the body to access the fat stores in the body and provide nutrients for when a woman is pregnant with a baby. This function can then be exploited to help people to lose weight. People usually take the HCG supplement plus a 500 calorie per day diet, and the theory is that this could help them shed one or two pounds every day.

 

If something sounds too good to be true, it probably is. This is certainly the case with HCG. In fact, the Food and Drug Administration, alongside the Federal Trade Commission, have actually issued a large number of warning letters to the companies who are selling over-the counter products containing HCG and labelled as a homeopathic weight loss remedy. This is because HCG has not been approved to be used for weight loss, and the claims that the products are making does not have any evidence to back it up. In addition to this, the hormone may have health risks associated with it, due to the lack of testing and evidence, and there are also serious health effects associated with very low calorie diets.

Categories: fda, hCG, homeopathic, loss, nbsp, Pregnant, weight, Weight Loss

Products Labelled as a Supplement Not to be Marketed as Food

The Food and Drink Administration (FDA) has sent out a warning, designed to protect the wellness and wellbeing of consumers, stating that products that are labelled as a dietary supplement may not be labelled as a conventional food product.

With many vitamins, minerals and supplements on the shelves these days, the FDA wants to ensure that all consumers are aware of exactly what they are purchasing.

This has originated from a row over a company called Nature’s Health Options LLC, which is the distributor of a product called Charantea Bitter Melon Ampalaya. They produce this either as 500mg capsules and also as teabags. They were recently accused of making statements on their website that appeared to represent the product as a traditional food rather than a supplement.

The FDA has got in touch with all companies to make it clear that if something is labelled as a dietary supplement, it must be a dietary supplement. If it is more of a conventional food, then it is misbranded, and the label of supplement is therefore misleading to the consumer.

Charantea’s website was particularly highlighted as an example of this, and the FDA letter drew attention to the statement which described the tea as ‘a great alternative to coffee or traditional teas’ (thus representing it as a foodstuff – an everyday drink) and also to ‘your healthy after-meal beverage’. This is a strong contrast to Nature’s Health Options’ own description of the product as a vegetable and medicinal herb that grows in South America and Asia.

 

Categories: fda, Food, supplement