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Journal : Al Makki Health Informatics Journal

Harnessing Artificial Intelligence in Generic Formulation Development and Life Cycle Management - A Comprehensive Review Babu, Murali Mohan; Luh Putu Nurshanti, Ni; Martha Wijaya, Harry; R. Tjandrawinata, Raymond
Al Makki Health Informatics Journal Vol. 3 No. 1 (2025): Al Makki Health Informatics Journal
Publisher : Al Makki Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.57185/hij.v3i1.45

Abstract

Artificial intelligence (AI) is revolutionizing the pharmaceutical industry by enhancing efficiency, precision, and cost-effectiveness in drug development. This study explores the application of AI in the lifecycle management of generic drugs, focusing on key stages such as active pharmaceutical ingredient (API) synthesis, excipient selection, pre-formulation studies, bioequivalence testing, and regulatory compliance. By leveraging machine learning algorithms, AI facilitates predictive modeling, risk assessment, and optimization of drug formulation processes, reducing time-to-market and improving scalability. Despite significant advancements, challenges such as data quality, algorithm transparency, and infrastructure limitations persist, particularly in resource-constrained settings. This review highlights case studies and emerging technologies that address these challenges, providing actionable insights for pharmaceutical stakeholders. The study also discusses AI's potential to streamline supply chain logistics, enhance accessibility, and ensure regulatory adherence. By integrating AI across all stages of generic drug development, this research underscores its transformative potential in improving drug affordability, accessibility, and patient outcomes globally.
Co-Authors Achmad K. Harzif Agung Endro Nugroho Agung Endro Nugroho Andon Hestiantoro Andri Prasetiyo Anindini Winda Amalia Anindyajati Anindyajati Anita Artarini Armini Syamsidi ARTARINI, ANITA B. Atawolo, Andreas Babu, Murali Mohan Budi Wiweko Caroline G. Puspita CATUR RIANI Danang Agung Yunaidi Dayana, Hepy Debbie S. Retnoningrum Debbie S. Retroningrum DEBBIE SOEFIE RETNONINGRUM Dewi Riskha Nurmalasari Diana Nur Afifah Esti Mumpuni Esti Mumpuni Esti Mumpuni, Esti Gayatri, Anggi Gita Pratama Hapsari, Riani Hartati Tuna, Hartati Heliany, Ina Henry Soelistyo Budi Henry Soelistyo Budi, Henry Soelistyo Herbert Situmorang Herbert Situmorang Huda Shalahudin Darusman Indriawati, Iin Irsan Hasan Ismaya, Wangsa T. Kaka Renaldi Kanadi Sumapradja Krisnayanti, Ni Putu Eka Kristiana, Hery Kristiana, Hery Laurentia Stephani Lee, Hee Jae Liana W. Susanto Lilik Sulastri Luh Putu Nurshanti, Ni Maggy T. Suhartono Maggy T. Suhartono Maggy Thenawidjaja Suhartono Marcellus Simadibrata Martha Wijaya, Harry Melva Louisa Murdani Abdullah Nafrialdi Nafrialdi Nailufar, Florensia Nailufar, Florensia Novia Tri Astuti Novia Tri Astuti Novitasari, Putri Rachma Permanasari, Silmi Citra Rachman, Andika Raden Muharam Natadisastra Retroningrum, Debbie S. Rosyidah, Citra Santi Tan Saut Horas Hatoguan Nababan Setiabudy, Rahajuningsih D Shirly Kumala SILMI MARIYA Simatupang, Stefeny Theresia Sinaga, Wenny S.L. Soelistyo Budi, Henry Susanto, Liana W Suwijiyo Pramono Suwijiyo Pramono Tan, Santi Viedya Novalinda Said Wahyunia Likhayati Septiana Wangsa T. Ismaya Wangsa Tirta Ismaya Wawaimuli Arozal Widjaja, Nadia Winoto, Imelda L Winoto, Imelda L Yanti Lim Zaelani, Bella Fatima Dora