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International Journal of Science, Strategic Management and Technology

An International, Peer-Reviewed, Open Access Scholarly Journal Indexed in recognized academic databases · DOI via Crossref The journal adheres to established scholarly publishing, peer-review, and research ethics guidelines set by the UGC

ISSN: 3108-1762 (Online)
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JOURNEY OF A DRUG: FROM DISCOVERY TO REGULATORY APPROVAL: A COMPREHENSIVE REVIEW

AUTHORS:
Dipayan Shil
Mentor
Sonu Thakur
Affiliation
Guru Nanak College of Pharmaceutical Sciences, Dehradun
CC BY 4.0 License:
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract

Drug discovery and development is a complex, multidisciplinary process that integrates pharmacology, medicinal chemistry, toxicology, bioinformatics, regulatory science, and clinical research to identify, optimize, and evaluate therapeutic agents. The traditional drug development pipeline is lengthy, costly, and associated with high attrition rates. However, significant advancements between 2020 and 2026 have transformed the pharmaceutical landscape through the adoption of artificial intelligence (AI), machine learning, high-throughput screening, computational modeling, and systems biology approaches. These technologies have enhanced target identification, lead optimization, and prediction of drug efficacy and safety, thereby improving the efficiency of drug development.


Recent innovations in precision medicine, genomics, biomarker-driven therapies, and adaptive clinical trial designs have further accelerated the translation of scientific discoveries into clinical applications. Additionally, emerging modalities such as RNA-based therapeutics, gene editing technologies, and advanced drug delivery systems have expanded treatment possibilities for complex diseases. This review provides a comprehensive overview of contemporary trends, technological advancements, regulatory considerations, and future perspectives in drug discovery and development from 2020 to 2026, highlighting their impact on improving therapeutic outcomes and reducing development timelines.

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Shil, D. (2026). Journey of a Drug: From Discovery to Regulatory Approval: A Comprehensive Review. International Journal of Science, Strategic Management and Technology, 02(6). https://doi.org/10.55041/ijsmt.v2i6.113

Shil, Dipayan. "Journey of a Drug: From Discovery to Regulatory Approval: A Comprehensive Review." International Journal of Science, Strategic Management and Technology, vol. 02, no. 6, 2026, pp. . doi:https://doi.org/10.55041/ijsmt.v2i6.113.

Shil, Dipayan. "Journey of a Drug: From Discovery to Regulatory Approval: A Comprehensive Review." International Journal of Science, Strategic Management and Technology 02, no. 6 (2026). https://doi.org/https://doi.org/10.55041/ijsmt.v2i6.113.

References
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2.Blanco-González, A., Cabezon, A., Seco-González, A., & Revuelta, J. L. (2023). The role of artificial intelligence in drug discovery: Challenges, opportunities, and strategies. Pharmaceuticals, 16(6), 891. https://doi.org/10.3390/ph16060891

3.Serrano, D. R., Lalatsa, A., Dea-Ayuela, M. A., Bilbao-Ramos, P., Garrett, N. L., Moger, J., & Guarrochena, X. (2024). Artificial intelligence applications in drug discovery and development. Pharmaceutics, 16(10), 1265. https://doi.org/10.3390/pharmaceutics16101265

4.Zhang, K., Xiao, C., Glass, L. M., & Sun, J. (2025). Artificial intelligence in drug development. Nature Medicine, 31, 1–15. https://doi.org/10.1038/s41591-024-03434-4

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7.Deng, J., Yang, Z., Ojima, I., Samaras, D., & Wang, F. (2021). Artificial intelligence in drug discovery: Applications and techniques. Briefings in Bioinformatics, 22(6), bbab430. https://doi.org/10.1093/bib/bbab430

8.Sun, D., Gao, W., Hu, H., & Zhou, S. (2022). Why 90% of clinical drug development fails and how to improve it. Acta Pharmaceutica Sinica B, 12(7), 3049–3062. https://doi.org/10.1016/j.apsb.2022.02.002

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This article has undergone plagiarism screening and double-blind peer review. Editorial policies have been followed. Authors retain copyright under CC BY-NC 4.0 license. The research complies with ethical standards and institutional guidelines.
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