Drugdiscovery >> Drugs >> News
How Drugs are Developed and Approved - drugdiscovery.com


How Drugs are Developed and Approved - drugdiscovery.com
In the United States, all medications except natural remedies and supplements, must go through an approval process before they can be made available to people. The Food and Drug Administration (FDA) is responsible for ensuring that these drugs, whether they are prescription or over the counter, are effective and safe. As part of the FDA, the Center for Drug Evaluation and Research (CDER) controls the introduction of drugs to the market.

Initial Development

This is the beginning of the whole approval process. The company spends years developing a drug. They test compounds and ingredients to determine multiple factors including effectiveness and dosages as a starting point.

Phase 1

The company submits an application to the FDA for investigative permission. The drug is then called an investigational new drug (IND). If it is approved, the drug begins the road to clinical trials. This first phase lasts about a year and involves between 20 and 80 healthy patient volunteers to test it. The volunteers are given slowly increasing doses to help establish the properties of the drug and its safety for people.

Phase 2

In the second phase, 100 to 300 patient volunteers are used. This phase lasts about two years. Its purpose is to determine the potential effectiveness, delivery method, and intervals of dosing for the IND. The volunteers are a targeted group, usually comprised of patients who suffer from the condition the drug is supposed to treat.

Phase 3

If the IND makes it through phase 2, it is now in the final step of clinical trials. This phase is often the longest, averaging between two and ten years. About 1,000 to 3,000 current patients of hospitals and clinics are involved. They are monitored for side effects, adverse reactions, and overall effectiveness.

Final Stretch

After Phase 3, the company must then submit a New Drug Application (NDA). This application will contain all the data collected during the development and three phrases. It includes information about the composition, manufacturing process, and proposed labeling of the drug. From this point the FDA reviews the data, conducts an independent study, and then makes a recommendation. This process can take between six and twelve months.

The FDA can deny or approve an application. If it is denied, the company is provided with reasons why and what can be done for an approval. An approval means the drug can be put on the market.

By Eszter Hazai, PhD Google+

Tags: FDA, CDER, drug safety - July 15, 2013


Related Articles
5704
Views
The truth about herbal drugs The truth about herbal drugs
Echinacea, ringflower, ginger... Nature helas everything. But what is up with herbaldrugs?Are they really effective? What is in the little green bottle? Read More >>

Tags: effective, drug, green drugs

5179
Views
Drugs during chemotherapy Drugs during chemotherapy
Chemotherapy can be carried out via infusion or with the help of pills to swallow. To maintain your health and progress, it is very important to know about all the drugs and possibilities which are us Read More >>

Tags: treatments, cancer, drugs,

9958
Views
Common prescription drugs  can have beneficial side effects Common prescription drugs can have beneficial side effects
A greater number of recent studies show that some prescription drugs, like statins, flu shots, metformin and some others, might actually have surprising benefits for our health. Read More >>

Tags: prescription, drugs, side effect, metformin, statins, flu shot, levodopa, aspirin

6064
Views
The future of orphan drugs The future of orphan drugs
Orphan drugs are gaining more and more popularity among drug makers. Find out why and which are the top projected 2018 sellers. Read More >>

Tags: orphan drugs, top 20, pharma companies

4682
Views
Children drugs might be dangerous Children drugs might be dangerous
Children cough and fever medicine were reported to be dangerous last year. Many of the manufacturers withdrew their product volunteering. However, there are still products, which might mean a risk for Read More >>

Tags: children, drugs, medicine, danger

4688
Views
Why combo cancer drugs fail at clinical trials Why combo cancer drugs fail at clinical trials
Combo cancer drugs are often prove to be ineffective when it comes to clinical trials. According to the latest researches this is because one drug makes the other ineffective. Can this problem be solv Read More >>

Tags: clinical trial, combo drugs

3454
Views
Blood pressure drugs plus allergy - it might even be lethal Blood pressure drugs plus allergy - it might even be lethal
Several common blood pressure drugs can be a lethal combo for if you suffer from certain type of allergy. Doctors warn us to pay attention to side effects which might be difficult to find. Read More >>

Tags: drug discovery, doctors, blood pressure drugs, allergy, side effect

5952
Views
The most promising experimental cancer drugs-2013 The most promising experimental cancer drugs-2013
An expert’s opinion on the 10 most prospective experimental cancer drugs in 2013. Read More >>

Tags: top 10, experimental drugs, cancer, prospective, promising, cancer drugs, experimental

10927
Views
Another Sanofi MS drug approved in EU Another Sanofi MS drug approved in EU
After Aubagio, Lemtrada - another Sanofi’s drug for treatment of multiple sclerosis has been approved by the European Commission. Read More >>

Tags: multiple sclerosis, Europe, new drug, Aubagio, Lemtrada

6489
Views
Remicade Copies Approved in Europe Remicade Copies Approved in Europe
J&J’s Remicade, a drug for arthritis, will have cheaper versions made and sold by two other companies in Europe by 2014. Read More >>

Tags: Remicade, Arthritis, Celltrion, Hospira

MOST VIEWED
HOME | ABOUT | PRIVACY POLICY | TERMS & CONDITIONS | ADVERTISE | CONTACT
All rights reserved drugdiscovery.com 2013