R & D

Once potential drug candidates are identified, they undergo preclinical testing in laboratories and animal models. This phase assesses the safety, efficacy, and toxicity of the compounds.

If a drug candidate passes the preclinical phase, it moves on to clinical trials. These are divided into three phases: Phase I: Small-scale trials with healthy volunteers to determine safety, dosage, and side effects.

Phase II: Larger trials with patients to assess efficacy and side effects in a controlled setting.

Phase III: Large-scale trials with a diverse patient population to confirm efficacy, monitor side effects, and gather data for regulatory approval.

After successful completion of clinical trials, the pharmaceutical company submits data to regulatory agencies like the U.S. Food and Drug Administration (FDA) for approval. If granted, the drug can be marketed and sold.

Even after approval, drug safety continues to be monitored through post-marketing surveillance. Any adverse events or unexpected side effects are tracked, and regulatory agencies may take action if safety concerns arise.

Pharmaceutical companies also invest in R&D related to manufacturing processes to ensure consistent quality, scalability, and cost-effectiveness of drug production.

In addition to traditional small molecule drugs, the pharmaceutical industry is increasingly involved in biotechnology R&D. This includes the development of biologics, gene therapies, and cell therapies.