Literature Review Methodologies in Drug Development

This guide discusses the significance of literature reviews in the pharmaceutical and healthcare industries, emphasizing their role in evidence generation throughout the drug development and commercialization lifecycle. It defines a literature review as a structured evaluation aimed at identifying, evaluating, and synthesizing peer-reviewed evidence relevant to specific research objectives. The document outlines two primary methodologies: Systematic Literature Reviews (SLRs) and Targeted Literature Reviews (TLRs). SLRs are characterized by their systematic approach to evidence synthesis, ensuring transparency and reproducibility, while TLRs provide a more focused method suited for specific research questions. The guide further explains the critical importance of selecting the appropriate methodology based on research objectives, resources, and regulatory requirements. It highlights how literature reviews support health technology assessments, regulatory submissions, and inform research development, ultimately enhancing credibility and publication opportunities.