Ravimiuuringud

Ravimiuuringud, or drug research, denotes the systematic investigation into medicines to determine their safety, efficacy, quality, and appropriate use. The field covers the entire lifecycle of a medicine, from early discovery to regulatory approval and post-marketing monitoring.

The development process typically begins with preclinical studies, including laboratory and animal experiments that assess pharmacology and toxicology. If results are favorable, the project moves to clinical development, which is usually divided into phases I–IV. Phase I tests safety, tolerability and pharmacokinetics in a small group of volunteers or patients. Phase II explores efficacy and dosing in a larger group. Phase III confirms effectiveness and monitors adverse events in diverse populations. Phase IV occurs after a medicine is approved and marketed, continuing pharmacovigilance and sometimes identifying new uses or risks.

Clinical research relies on rigorous study designs, such as randomized controlled trials, with randomization, control groups and blinding where feasible. Endpoints may include clinical outcomes, biomarker changes, and quality of life measures. Data analysis emphasizes statistical validity, bias reduction and reproducibility.

Ethics and regulation guide Ravimiuuringud. Informed consent, independent ethics committees, and data safety monitoring are required. Compliance with Good Laboratory Practice and Good Clinical Practice helps ensure participant protection and data integrity. Regulatory authorities, such as the European Medicines Agency or other national agencies, assess safety, efficacy and manufacturing quality for marketing authorization. Ongoing pharmacovigilance after approval informs risk-benefit decisions and labeling.