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Uji Klinik Terdesentralisasi: Mendefinisikan Ulang Partisipasi, Kuasa, dan Presisi dalam Riset Kesehatan Raymond R. Tjandrawinata
MEDICINUS Vol. 38 No. 6 (2025): MEDICINUS
Publisher : PT Dexa Medica

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56951/trzykz54

Abstract

Decentralized clinical trials (DCTs) have emerged as a transformative force in biomedical research, breaking down traditional boundaries and reshaping how evidence is generated, validated, and applied. By leveraging digital health technologies, real-world data, and remote engagement infrastructures, DCTs have the potential to democratize clinical research by improving inclusivity and accessibility. However, these opportunities come with challenges related to regulatory governance, technological ethics, and socio-political representation. This brief article explores both the conceptual and empirical foundations of DCTs, drawing from recent studies, international policy documents (such as white papers), regulatory initiatives, and global practice surveys. It examines the epistemological, operational, and normative shifts introduced by DCTs and proposes a framework for understanding their impact on three core dimensions of clinical science: participation, power, and precision. Ultimately, this article argues that DCTs are not merely a digital enhancement, but rather a fundamental reconfiguration of how health knowledge is generated and governed.
Epigenom yang Berkembang: Fungsi dan Aplikasinya Raymond R. Tjandrawinata
MEDICINUS Vol. 38 No. 7 (2025): MEDICINUS
Publisher : PT Dexa Medica

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56951/1cyz2p11

Abstract

Epigenome is a set of reversible modifications that synergistically regulate gene expression without altering the DNA sequence. The epigenome serves as a functional bridge between the genome and the environment, enabling precise spatiotemporal regulation of gene expression, which is crucial for cellular identity and development of organisms. Unlike the static genome, the epigenome is dynamic and responsive to endogenous and exogenous signals, including developmental, metabolic, environmental stress, and pathological conditions. This paper comprehensively reviews the fundamental mechanisms of epigenetic dynamics, its role in phenotype formation, and its implications in disease etiology and therapeutic innovation. By integrating cutting-edge findings from developmental biology, oncology, neurobiology, and regenerative medicine, the epigenome can be understood as a multidimensional lens for interpreting biological memory, developmental plasticity, and potential molecular engineering.
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.
Tinjauan Terpadu terhadap Terapi Presisi dan Standardized Herbal Drug untuk Non-Alcoholic Fatty Liver Disease (NAFLD): Kemajuan Molekuler, BuktiKlinis, serta Implikasi Integratif Raymond R. Tjandrawinata
MEDICINUS Vol. 38 No. 7 (2025): MEDICINUS
Publisher : PT Dexa Medica

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56951/mh4ry926

Abstract

Non-alcoholic fatty liver disease (NAFLD) is a progressive hepatic disorder that has become a central component of the global metabolic syndrome spectrum. Its complex pathogenesis involves insulin resistance, chronic inflammation,oxidative stress, and activation of fibrogenic pathways. Along with the deepening understanding of molecular mechanisms,precision therapies targeting farnesoid X receptor (FXR) agonists, peroxisome proliferator-activated receptor (PPAR) modulators, incretin mimetics, and RNA-based technologies are being developed, although challenges remain concerningside effects and accessibility. In this context, Veprolin containing Proliverenol, a bioactive fraction of Phaleria macrocarpa, offers potential as an adjuvant standardized herbal drug with anti-inflammatory, antifibrotic, and reparative effects, as demonstrated in preclinical studies. This review highlights the importance of integrative, precision-oriented, and sustainable multimodal therapeutic strategies.
Clinical Study of DLBS2411, a Mucoprotector and Proton Pump Inhibitor Bioactive Fraction Derived From Cinnamomum burmanii, on the Intragastric Acidity Tjandrawinata, Raymond Rubianto; Abdullah, Murdani; Simadibrata, Marcellus; Susanto, Liana W; Renaldi, Kaka
The Indonesian Journal of Gastroenterology, Hepatology, and Digestive Endoscopy Vol 26, No 1 (2025): VOLUME 26, NUMBER 1, April, 2025
Publisher : The Indonesian Society for Digestive Endoscopy

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24871/261202543-54

Abstract

Background: DLBS2411, A bioactive fraction derived from the bark of Cinnamomum burmanii has been developed to address acid-related gastrointestinal disorders. This study evaluated the pharmacodynamic effect of DLBS2411 on the 24-hour intragastric acidity in healthy adults.  Methods: In a 3-arm, parallel, double-blind, randomized, placebo-controlled clinical trial, healthy subjects received a single dose of DLBS2411 (250 mg or 500 mg) or placebo. Gastric pH was monitored, analyzed and profiled over 24 hours. Results: Of a total of 54 enrolled male subjects, 47 subjects (87.04%) were eligible for the analysis. The mean 24-hour intragastric pH for DLBS2411 250 mg and 500 mg was 2.29 ± 0.42 and 2.13 ± 0.50, respectively, both higher than placebo (1.93 ± 0.70). Differences were more pronounced during the first 12 hours (daytime). DLBS2411 250 mg and 500 mg reached a gastric pH 4 significantly faster (129.9 ± 128.2 and 92.9 ± 106.8 minutes) compared to placebo (196.9 ± 99.7 minutes). No serious adverse events occurred. All adverse events were mild and had been resolved by the end of study, confirming the safety and tolerability of DLBS2411 at the dose of 250 and 500 mg. Conclusion: DLBS2411 effectively suppressed the intragastric acidity and demonstrated a good safety profile in healthy adults. These findings warrant further studies of DLBS2411 in patients with gastric acid-related disorders. Keywords: Alternative medicine, DLBS2411 cinnamomum burmanii, healthy volunteers, intragastric-acidity, proton pump inhibitors
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.
Pendekatan Integratif dalam Manajemen Dengue Raymond R. Tjandrawinata
MEDICINUS Vol. 38 No. 8 (2025): MEDICINUS
Publisher : PT Dexa Medica

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56951/699q0n64

Abstract

Dengue, as one of the most challenging tropical diseases of the 21st century, continues to present significant clinical and epidemiological complexities in developing countries, including Indonesia. With the increasing incidence of global dengue infections and the limited availability of definitive therapeutic options, clinical management is shifting toward optimizing supportive therapy and exploring adjuvant strategies to improve key clinical parameters such as hemodynamic and platelet count. By emphasizing the role of two interventions, Gelafusal (gelatin solutions) as a colloid fluid for resuscitation and Psidii (Psidium guajava folium extracts) as a platelet production-stimulating agent, through the lens of bioethics, pharmacodynamics, and evidence-based clinical strategies, this review offers a critical reflection on the opportunities and limitations of applying multimodal interventions in dengue management.
Inovasi dan Praktik Terbaik dalam Model Tikus Hasil Rekayasa Genetik untuk Penelitian Praklinis dan Translasional Raymond R. Tjandrawinata
MEDICINUS Vol. 38 No. 8 (2025): MEDICINUS
Publisher : PT Dexa Medica

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56951/26jxqx92

Abstract

Genetically engineered mouse models (GEMMs) have undergone significant evolution since their initial development in the late 1980s. Over the past decade, advancements in genome editing technologies such as clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9, base editing, and prime editing, have sparked a new wave of innovation in the design and application of GEMMs. This article explores the historical development of GEMMs, recent technical advancements beyond CRISPR, their broad-spectrum applications across diseases, including autoimmune and cardiovascular, integration of multiomics approaches, and the role of GEMMs in pharmacokinetic and pharmacodynamicstudies. It also addresses aspects of colony management, experimental animal ethics, international regulations, convergence with artificial intelligence, and case studies of successful clinical translation based on studies using GEMMs. By synthesizing the latest literature from various international databases, this article provides a strategic guide for researchers to optimize the potential of GEMMs in improving the accuracy and translational relevance of innovative therapy development.
Network pharmacology‐based exploration of gut microbiota‐derived metabolites for type‐2 diabetes Widjaja, Nadia; Simatupang, Stefeny Theresia; Tan, Santi; Tjandrawinata, Raymond Rubianto
Indonesian Journal of Biotechnology Vol 30, No 3 (2025)
Publisher : Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/ijbiotech.107382

Abstract

Probiotics confer health benefits and have been investigated for their potential therapeutic properties in type‐2 diabetes (T2D) treatment. This study employs a network pharmacology approach to explore gut microbiota‐derived metabolites that potentially alleviate T2D. Several strains and species of gut microbiota were identified that may produce metabolites with therapeutic potential for T2D. Interestingly, quercetin produced by Bacteroides uniformis and daidzein produced by Bifidobacterium adolescentis and Bifidobacterium breve have been studied for their antidiabetic effects. Using a network pharmacology approach, it was found that quercetin may target AKT1 and EGFR, critical proteins involved in insulin signaling pathways related to T2D. Additionally, 10‐oxo‐11‐octadecenoic acid produced by Lactobacillus plantarum and 10‐keto‐12Z‐octadecenoic acid produced by Lactobacillus paracasei were found to target PPARG, a gene regulating insulin signaling. These findings were further validated by the molecular docking analysis, which showed suitable to satisfactory binding strengths.
Farmakogenomik dalam Pengobatan Presisi: Tinjauan dengan Studi Kasus Clopidogrel dan Tren Masa Depan Raymond R. Tjandrawinata
MEDICINUS Vol. 38 No. 9 (2025): MEDICINUS
Publisher : PT Dexa Medica

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.56951/fqx9vg55

Abstract

Pharmacogenomics has emerged as a cornerstone in the development of precision medicine, aiming to tailor drug therapy based on an individual’s genetic profile. By identifying genetic variations that influence drug metabolism, efficacy,and safety, pharmacogenomics paves the way for improved therapeutic outcomes reduced adverse drug reactions. One of the most significant examples in clinical practice is clopidogrel, an antiplatelet agent whose biopharmacologicalactivation depends on the CYP2C19 enzyme. Genetic variations in CYP2C19 significantly affect the clinical effectiveness of clopidogrel and the risk of major cardiovascular events. This article outlines recent developments in the implementationof pharmacogenomics, focusing on the clopidogrel case study, while also exploring other key gene–drug interactions such as codeine/CYP2D6, warfarin/VKORC1, and statin/SLCO1B1. The review also maps future trends in pharmacogenomics,including multiomic integration, preemptive genotyping, AI-based predictive modeling, and the potential for gene-editing interventions such as clustered regularly interspaced short palindromic repeats (CRISPR). Despite significant progress,implementation challenges remain, ranging from cost and healthcare infrastructure to ethical and regulatory dilemmas. This review aims to provide both a conceptual and practical foundation for the development of truly personalized pharmacotherapy in the future.
Co-Authors . Anindyajati Achmad K. Harzif Agung Endro Nugroho Agung Endro Nugroho Andon Hestiantoro Andreas Bernadinus Atawolo Andri Prasetiyo Anindini Winda Amalia Anita Artarini Armini Syamsidi ARTARINI, ANITA Babu, Murali Mohan Budi Wiweko Caroline G. Puspita CATUR RIANI Danang Agung Yunaidi Dayana, Hepy Debbie S. Retnoningrum Debbie S. Retroningrum DEBBIE SOEFIE RETNONINGRUM DERMAWAN, DONI Dewi Riskha Nurmalasari Diana Nur Afifah Esti Mumpuni Esti Mumpuni Esti Mumpuni, Esti Gayatri, Anggi Gita Pratama Hapsari, Riani Harry Martha Wijaya Hartati Tuna, Hartati Heliany, Ina Henry Soelistyo Budi Henry Soelistyo Budi, Henry Soelistyo Herbert Situmorang Herbert Situmorang Hiendrawan, Stevanus Huda Shalahudin Darusman Indriawati, Iin Irsan Hasan Ismaya, Wangsa T. Kaka Renaldi Kanadi Sumapradja Krisnayanti, Ni Putu Eka Kristiana, Hery Kristiana, Hery Laurentia Stephani 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 Murali Mohan Babu Murdani Abdullah Nafrialdi Nafrialdi Nailufar, Florensia Nailufar, Florensia Ni Luh Putu Nurshanti Novia Tri Astuti Novia Tri Astuti Novitasari, Putri Rachma Permanasari, Silmi Citra Rachman, Andika Raden Muharam Natadisastra Retroningrum, Debbie S. Santi Tan Saut Horas Hatoguan Nababan Setiabudy, Rahajuningsih D Shirly Kumala SILMI MARIYA Simatupang, Stefeny Theresia Sinaga, Wenny S.L. Soelistyo Budi, Henry Steven Susanto, Liana W Suwijiyo Pramono Suwijiyo Pramono Tan, Santi Viedya Novalinda Said Wangsa T. Ismaya Wangsa Tirta Ismaya Widjaja, Nadia Winoto, Imelda L Winoto, Imelda L Yanti Lim Zaelani, Bella Fatima Dora