 | DiscoveryDrug discovery focuses on identifying and validating biological targets linked to a disease, such as proteins or genes.1 Scientists then use laboratory experiments, computational modeling, and high-throughput screening to search for molecules that can interact with and modulate these targets. During this stage, researchers fine-tune the structure or composition of promising leads to improve potency, selectivity, and stability, narrowing down the number of candidates with the best potential to move forward. |
 | Preclinical and Clinical TrialsIn preclinical development, candidate drugs are typically tested in laboratory and animal studies to assess toxicity and how the drug behaves in a living system.2 Successful candidates may enter clinical trials in humans, which have several phases. Phase 1 clinical trials evaluate safety and dosage, Phase 2 trials focus on effectiveness and adverse reactions, and Phase 3 testing confirms efficacy while monitoring safety in larger populations, sometimes comparing new therapies to already approved drugs. These trials generate critical data needed to determine whether a drug’s benefits outweigh its risks.3 |
 | Regulatory Compliance, Manufacturing, and Post‑Market SurveillanceDuring and after clinical trials, regulatory agencies review trial data to decide whether a drug can be approved.3 Therapeutic manufacturing must follow Good Manufacturing Practice (GMP) standards to ensure consistent quality, safety, and purity.4 After approval, the drug is monitored through post-market surveillance to detect rare or long-term side effects. This ongoing oversight helps protect patients and ensures that medicines remain safe and effective throughout their use. |
- Hughes JP, et al. Principles of early drug discovery. Br J Pharmacol. 2011;162(6):1239-1249.
- Southey MW, Brunavs M. Introduction to small molecule drug discovery and preclinical development. Front Drug Discov. 2023;3:1314077.
- Singh N, et al. Drug discovery and development: Introduction to the general public and patient groups. Front Drug Discov. 2023;3:1201419.
- Sampathkumar K, Kerwin BA. Roadmap for drug product development and manufacturing of biologics. J Pharm Sci. 2024;113(2):314-331.
