Discovery and Target Identification
We study diseases and identify specific molecular targets or pathways that play a role in the disease’s development or progression. These targets could be proteins, enzymes, receptors, or genetic factors.
Drug Development
Once a target is identified, we begin the process of developing potential drugs that can interact with our target and modify its activity. This phase involves synthesizing and testing numerous compounds for us to find the most promising candidates.
Preclinical Testing
In this stage, we undergo rigorous laboratory testing using cell cultures and animal models to evaluate their safety, efficacy, and potential side effects. These tests help us understand the drug’s pharmacokinetics (absorption, distribution, metabolism, and excretion) and pharmacodynamics (how the drug interacts with the body).
Clinical Trials
After a potential drug shows promise in preclinical testing, it progresses to human clinical trials. Clinical trials are conducted in several phases (Phase I, II, III) and involve human participants to assess the drug’s safety, dosage, effectiveness, and potential adverse effects. We do these trials carefully and they require the approval of regulatory authorities.
Regulatory Approval
Once our clinical trials demonstrate that a drug is safe and effective, the pharmaceutical company submits a New Drug Application (NDA) to the regulatory authorities (such as the U.S. Food and Drug Administration, FDA). The authorities review the application and decide whether to approve the drug for marketing and public use.
Post-Marketing Surveillance
After a drug is approved, we continue to monitor for safety and effectiveness in real-world conditions. This phase involves ongoing research and surveillance to detect any previously undetected side effects or long-term effects.