The Drug Development Process in Detail

  • Added:
    Dec 10, 2012
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Drug discovery can happen in several ways: accidentally, after extensive testing of animals or plants or fungi, on analyzing the characteristics of growth cells, by evaluating chemical composition of a drug target and during other clinical tests. Once a potential drug is discovered, the drug development process begins.

The important phases of drug development process are:

Lead Discovery and Optimization

In this phase, the discovered compound is tested to ensure that it has the potential to become a drug.

Preclinical Development Phase

The new drug is produced or manufactured in sufficient quantity to continue with preclinical testing and for clinical trials. During this phase, the preclinical trials are conducted to collect data with respect to safety and pharmacology. This phase is aimed at determining the suitability of the drug for the intended use by studying the effect of the new drug on blood and tissues.

Application for IND

Application for Investigational New Drug (IND) approval is submitted to the concerned regulatory agencies. The drug can be administered on humans only after an approval of IND.

Clinical Development Phase

This phase is branched into three sub-phases.

During the first sub-phase the drug is tested on less than hundred healthy volunteers and the dosage and effect details are collected.

During the second sub-phase the drug is tested for efficacy and side effects on a larger group of volunteers. These volunteers need to have the medical condition that this drug is used to treat.

During the third phase, the drug is administered to a large group of patients that could range between a few hundred to several thousands. This phase helps in determining the safety and effectiveness of the drug. During this phase, placebos are administered to compare the results.

Product Registration and Approval

The premarketing process begins during the first sub-phase of clinical development. This is done in order to ensure that the market expectations are met by the new drug. This continues throughout the three sub phases. During the last phase the drug is promoted at international symposiums. This activity creates awareness about the drug in the medical community.

During the final sub phase of clinical development, if the trials are successful, an application for approval of the new drug is submitted to the concerned regulatory body of the country where the drug was developed. This approval is needed to market the drug.

Post-approval Research

During this phase, the marketed drug is administered to patients and regularly monitored. This allows making improvements in the drug, to use the drug for different conditions, to compare with similar drugs and to determine the effectiveness of the drug.

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Drug discovery can happen in several ways: accidentally, after extensive testing of animals or plants or fungi, on analyzing the characteristics of growth cells, by evaluating chemical composition of a drug target and during other clinical tests. Once a potential drug is discovered, the drug development process begins. GlobalCompliancePanel


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