Pivotal study

{
  "id": "MLC-T-CHM-008987",
  "term": "Pivotal study",
  "field": "Chemistry",
  "definition": "A clinical trial or research investigation designed to provide definitive evidence of a drug's efficacy and safety for regulatory approval. These studies are typically large, well-controlled, and conducted in a patient population representative of the intended use. The results of a pivotal study are submitted to regulatory authorities like the FDA or EMA to support marketing authorization.",
  "subject": "Chemistry and Human Health",
  "see_also": [
    "molecular target",
    "proof of concept"
  ],
  "references": [
    "PAC, 2013, 85, 1725. 'Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)' on page 1747 (https://doi.org/10.1351/PAC-REC-12-11-23)"
  ],
  "url": "https://mlchart.com/terminology/chemistry/pivotal-study/"
}