Drug Development Process

The Center for Drug Development Process and Research is a specialized department of the FDA. This branch of the FDA is responsible for evaluation of new drugs. New drugs cannot be sold or manufactured before they have been approved. Prior to taking a new drug to the FDA for approval. Drug development is divided into two research processes: pre-clinical and clinical.

Pre-Clinical Research

Chemistry – The drug is created from multiple compaounds that has desired effect on target issue. Follows the “Drug Discovery” process.

Manufacturing – Chemists recommend dose and scheduling. Chemical metabolism, toxicity, stability and solubility are determined.

Control – Decision is made on the introduction method to the human body. Weather a drug is taken as a pill, aerosol, injectable, or liquid.


Clinical Research

Phase 1 Trials – Healthy volunteers used to stabilize dosing and safety parameters.

Phase 2 Trials – Uses small number of sick volunteers to determine drug effectiveness and safety.

Phase 3 Trials – Large number of patient volunteers to further document effectiveness and safety.

Phase 4 Trials – Post FDA approval monitoring of effectiveness and safety of drug use in patients.