Developing a new drug takes years of research and testing before it gets approved by FDA. The procedure of FDA approval is lengthy too and it takes many years before an approved drug hits the market. When it comes to developing a new drug, the factors pertaining uncertainty are high. Drug development is a challenging phase, especially, when new drugs for genetic or chronic ailments are introduced for research and development.
Identifying the Class of Drugs
This is an important aspect of drug development. The age and other conditions are analyzed before producing a formulation for a new drug. These formulations must prove to be effective at the cellular, biochemical, and functional level for the human body. During the process of development, the number of compounds to produce the formulation is reduced to two to three chemicals at the most.
Clinical Trials and Regulations
- Clinical trials are the lengthiest procedures used for a new drug
- There are also investigations conducted at each and every stage of drug development
- A new drug is tested on a human subject with the availability of doctors and healthcare professionals
- The reaction for the active and inactive chemicals in the compounds is tested
- Its effectiveness is analyzed through behavioral and physical changes in the patient
- There are different phases of conducting clinical trials
Drug Safety for Public Use
Only healthy volunteers are tested on new drugs. The absorption rate and its effectiveness are tested till the point of excretion of the drug. The treatment for which the drug is introduced is checked for its effect as a remedy to that ailment. At the next stage, its effect on different population with different quantity of dosage is checked and analyzed.
The Investigational New Drug Process
Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.
In the Investigational New Drug IND application, developers must include:
- Animal study data and toxicity (side effects that cause great harm) data
- Manufacturing information
- Clinical protocols (study plans) for studies to be conducted
- Data from any prior human research
- Information about the investigator
The FDA authorities visit laboratories, research and development centers, as well as manufacturing units to check for the safety of the drugs being developed. The investment made in drug development gives unpredictable results.