Year: 2025
Type: article
Abstract: The process of drug discovery and development is a long, complex, and highly regulated journey from initial concept to a marketable medicine available to patients. This review article provides a comprehensive overview of the key stages involved in bringing a new pharmaceutical product to market. It begins with the initial identification and validation of a biological target and proceeds through the intricate steps of lead compound discovery and optimization. The critical preclinical testing phase in vitro and in vivo is discussed, highlighting its role in establishing initial safety and efficacy prior to human testing. The article then details the three pivotal phases of clinical trials in human subjects, which assess safety, dosage, efficacy, and overall benefit-risk profile. Finally, the processes of regulatory review, approval, and post-marketing surveillance (Phase IV) are examined. This review underscores the significant challenges of time, cost, and high attrition rates that define the pharmaceutical industry, while also emphasizing the rigorous scientific and regulatory framework designed to ensure patient safety and therapeutic efficacy
Author: Mr. Tejas Guldagad
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: diamond
OpenAlex ID: W7082963333
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