Drug development is the process of bringing new medications from the early stages
of research to their availability for patient use. It involves a series of coordinated
steps and scientific efforts aimed at identifying and developing safe and effective
drugs to treat various diseases. The steps include:
Drug Discovery - Identify and design prospective drug compounds that have the potential to interact
with specific disease-related targets or pathways. Researchers may use computational
modeling, high-throughput screening and natural product isolation to identify promising
compounds that exhibit therapeutic properties.
Drug Development - Once potential drug candidates are identified, they undergo extensive testing in
preclinical studies. These studies test the efficacy of compounds and assess the safety,
distribution and pharmacokinetics (how the drug is absorbed, distributed, metabolized
and eliminated by the body) using molecular assays, cell culture and animal models.
Clinical Trials - This research is conducted to examine drug effects in humans. Researchers test
drug safety, dosage and effectiveness in human volunteers in phases that increase
the number of participants and monitoring parameters.
Regulatory Approval - Following successful clinical trials, drug developers submit an application to
regulatory authorities for approval to market the drug. Regulatory agencies review
the data from preclinical and clinical studies to ensure that the drug's safety and
efficacy meet established safety standards.
Drug Delivery - Drug delivery refers to the mechanisms and methods used to administer drugs to
patients. Drug delivery systems can include oral tablets, injectables, transdermal
patches, inhalers and other specialized devices.