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Liana W. Susanto
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Biochemistry, Genetics & Molecular Biology Immunology & microbiology Medicine & Pharmacology Neuroscience Public Health

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A Comprehensive Review of Bioequivalence Studies: Methodologies, Regulatory Considerations, and Future Directions Liana W. Susanto
MEDICINUS Vol. 38 No. 5 (2025): MEDICINUS
Publisher : PT Dexa Medica

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56951/80v3g940

Abstract

Bioequivalence studies are crucial for ensuring that generic formulations meet the safety and efficacy standards established by innovator products. This review explores the fundamental concepts of bioequivalence, the commonly employed study designs, and the current statistical methodologies used for evaluation. Regulatory frameworks from major agencies (e.g., FDA, EMA, and BPOM-RI) are outlined, while challenges in study design and interpretation are examined. Furthermore, future perspectives in bioequivalence research are considered, particularly as complex drug delivery systems and personalized medicine become more prevalent. Ongoing research and evolving guidelines will continue to shape this critical area of pharmaceutical science.
The Effect of Phaleria macrocarpa Bioactive Fraction (Proliverenol) Supplementation on Liver Damage in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) Irsan Hasan; Saut Horas Hatoguan Nababan; Raymond R. Tjandrawinata; Danang Agung Yunaidi; Liana W. Susanto
MEDICINUS Vol. 38 No. 7 (2025): MEDICINUS
Publisher : PT Dexa Medica

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56951/a4ba3z37

Abstract

Liver is considered one of the most vital organs, acting as the center of metabolism of nutrients and excretion of waste products. Non-alcoholic fatty liver disease (NAFLD) is one of the main causes of chronic liver disease. The management of NAFLD continues to evolve, and clinicians are currently faced with a variety of alternative options, both nonpharmacotherapeutic and pharmacotherapy, to avoid more severe liver disease. Phaleria macrocarpa (Scheff.) Boerl., namely, mahkota dewa in Indonesia, has been used empirically to treat cancer, allergy, and diabetes mellitus. Proliverenolis a proprietary bioactive fraction derived from the dried fruit of Phaleria macrocarpa (Scheff.) Boerl. Proliverenol was reported to have hepatoprotective, anti-inflammatory, antioxidant, and antifibrotic effects. The study found that Proliverenol bioactive fraction, at a dosage of 1000 mg twice daily for at least 4 weeks of treatment, is effective in improving liver damage with a good safety profile.
Co-Authors Danang Agung Yunaidi Irsan Hasan Raymond R. Tjandrawinata Saut Horas Hatoguan Nababan