Drug R&D Process Overview

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Please read the common information that follows

Many thousands of chemical substances are investigated each year for their possible benefits in alleviating human and animal diseases. Many organizations, such as companies, universities, and government agencies, are involved in drug research and development.
As you work with drug information you will often hear about the "R&D pipeline" or the "drug pipeline." This term refers to the progress of a drug/compound from the point it is discovered in the laboratory to its launch in the marketplace, if successful.
Every compound investigated for pharmaceutical potential must undergo rigorous testing as prescribed by government regulations. It is estimated that up to 5,000 compounds may be investigated for every one that ultimately makes it to the market as a pharmaceutical. In the United States, drug evaluation and testing is overseen by the Food & Drug Administration (FDA).
Organizations seeking drug approval in the United States must file two major regulatory documents with the FDA.
The first is submitted after pre-clinical or animal studies are completed in order to begin testing on humans. The formal name for this document is a Notice of Claimed Investigational Exemption for a New Drug, and is commonly referred to as an Investigational New Drug Application or IND. In the United States, human testing is done in three to four separately-evaluated steps or "phases."
After successful completion of testing on humans, final approval is sought from the FDA. The second major document filed is the New Drug Application, commonly referred to as the NDA. This document is filed to obtain approval to market the product.