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tag-personalized-medicine tag-predictive-toxicology" itemtype="https://schema.org/CreativeWork" itemscope> <div class="inside-article"> <div class="featured-image page-header-image-single "> <img width="1200" height="628" src="https://thepharma.net/archive/wp-content/uploads/2024/11/The-Future-of-Drug-Safety-01-min-scaled-e1731070230760.jpg" class="attachment-full size-full" alt="" itemprop="image" decoding="async" fetchpriority="high" /> </div> <header class="entry-header"> <h1 class="entry-title" itemprop="headline">The Future of Drug Safety: Integrated Microphysiological Systems and Predictive Toxicology</h1> <div class="entry-meta"> <span class="posted-on"><time class="entry-date published" datetime="2024-11-08T18:20:41+05:30" itemprop="datePublished">November 8, 2024</time></span> <span class="byline">by <span class="author vcard" itemprop="author" itemtype="https://schema.org/Person" itemscope><a class="url fn n" href="https://thepharma.net/archive/author/thepharma/" title="View all posts by thepharma" rel="author" itemprop="url"><span class="author-name" itemprop="name">thepharma</span></a></span></span> </div> </header> <div class="entry-content" itemprop="text"> <h4><b>Introduction</b></h4> <p><span style="font-weight: 400;">Drug development has always posed the strict challenge of having to test the drug candidates for safety and efficacy before they hit the market. While animal testing and cell cultures in vitro have earned invaluable information from the research, they usually fail in the prediction of human responses. Consequently, many drugs that seemed safe in preclinical models have caused adverse effects in human trials, with sometimes fatal results. This gulf between preclinical testing and clinical outcome has driven the search for more reliable models that are relevant to humans. Microphysiological systems (MPS), or organs-on-chips, These sophisticated in vitro models develop a paradigm shift in drug safety testing as they can model the complex physiological environments of tissues and organs in the human body. This is because MPS presents an opportunity to integrate several organ systems into a single platform with the goal of bridging the gap between preclinical studies and human clinical trials. It charts a course for more accurate and predictive preclinical assessment in toxicology.</span></p> <h4><b>Traditional drug safety testing has limitations</b></h4> <p><span style="font-weight: 400;">Testing for safety in drugs has traditionally relied on animal models and two-dimensional cell cultures. Such methods have contributed a great deal of information, but these traditional methods have some inherent limitations. Animal models are considered the gold standard for all preclinical tests, but they quite frequently fail in the prediction of human-specific responses because of interspecies differences in metabolism, genetics, and physiology. For instance, drugs that are safe for rodents or other animals are sometimes, in a very toxic way, human toxicants. This occurs at a great expense in terms of money and time when drug development has to be rolled back.</span></p> <p><span style="font-weight: 400;">Furthermore, 2D cell cultures miss the 3D architecture with complex cellular interactions of human tissues, something as simple as growing cells in a flat monolayer. This limitation frequently leads to an oversimplification of human biology and thus predicts the wrong drug efficacy and toxicity. Correspondingly, there has been a general recognition that more advanced models that better mimic human physiology are needed.</span></p> <h4><b>The Emergence of Microphysiological Systems</b></h4> <p><span style="font-weight: 400;">One of the successful resolutions toward the drawbacks of traditional drug testing methods is microphysiological systems, otherwise referred to as organs-on-chips. These devices make use of microfluidic technology to create miniature versions of human organs that house multiple cell types and recreate 3D architecture with mechanical forces similar to those in vivo. In this respect, MPS can model the dynamic environment of human tissue to better determine drug effects.</span></p> <p><span style="font-weight: 400;">Another advantage of MPS is the complex modeling of organ function and interaction within a controlled environment. For instance, a liver-on-chip can model the metabolic functions of the liver, thus providing an understanding of how a drug is processed and metabolized inside the human body. There has been a heart-on-chip designed that imitates the mechanical and electrical activities of the heart, allowing the in vitro study of drug-induced cardiotoxicity.</span></p> <p><span style="font-weight: 400;">Moreover, by binding various organ systems into a single platform, MPS enables the appreciation of kinetics between highly disparate tissues and organs, thereby finally furnishing an integrated view of the action of the tested compound. This is very important for the detection of drug interactions and off-target effects, which commonly cannot be determined by conventional testing models.</span></p> <p></div></div> <div style="background: #f7f7f7;border: 1px solid rgba(0, 0, 0, 0.07);"> <div style="padding: 30px;"><div class="Adblock-main"> <div class="Adblock-head"> <h2>Yearwise Publication Trend on <b>“<a href="https://thepharma.net/publication-trends/index/drug safety" target="_blank" title="drug safety - yearwise publication trends">drug safety</a>”</b></h2> </div> </div><div class="results-container"><div class="chart-block" style="padding:15px;"> <div class="left"> <div id="results" class="results"></div> </div> <div class="right"> <div class="chart-container"><canvas id="publicationChart"></canvas></div> </div> <div class="keywordsdiv"> <div style="text-align:center;"><b>Find publication trends on relevant topics</b> </div> <span class="gp-icon icon-tags"><svg viewBox="0 0 512 512" aria-hidden="true" xmlns="http://www.w3.org/2000/svg" width="1em" height="1em"><path d="M20 39.5c-8.836 0-16 7.163-16 16v176c0 4.243 1.686 8.313 4.687 11.314l224 224c6.248 6.248 16.378 6.248 22.626 0l176-176c6.244-6.244 6.25-16.364.013-22.615l-223.5-224A15.999 15.999 0 00196.5 39.5H20zm56 96c0-13.255 10.745-24 24-24s24 10.745 24 24-10.745 24-24 24-24-10.745-24-24z"></path><path d="M259.515 43.015c4.686-4.687 12.284-4.687 16.97 0l228 228c4.686 4.686 4.686 12.284 0 16.97l-180 180c-4.686 4.687-12.284 4.687-16.97 0-4.686-4.686-4.686-12.284 0-16.97L479.029 279.5 259.515 59.985c-4.686-4.686-4.686-12.284 0-16.97z"></path></svg></span> <span id="keyword-stats"></span> </div> </div></div></div><div class="inside-article"><style> table { margin: 0 0 1.5em; 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These integrated platforms, most of the time referred to as body-on-a-chip systems, are developed with the objective of simulating the complicated interactions between different organs and tissues for a truer simulation of human body responses to drugs.</span></p> <p><span style="font-weight: 400;">One example is a combination on one chip of the liver and heart models. Such a combination allows the investigator to simultaneously probe the interactions between the liver and heart caused by drugs metabolized by the liver, an interaction that is critical in the safety assessment of most pharmaceutical compounds. For instance, one study showed that a drug mainly metabolized by the liver revealed cardiotoxicity from the metabolites formed when an integrated heart-liver chip was introduced, indicating that testing should take into account organ chip-drug interaction in pharmacological safety assessment.</span></p> <p><span style="font-weight: 400;">Another meaningful development is multiorgan systems enhanced with tissues such as the lung, kidney, and brain to provide a broader view of the drug’s effects. Modeling the pharmacokinetics and pharmacodynamics of drugs in these kinds of systems would elaborate on how a drug is absorbed, distributed, metabolized, and eliminated in an organism. This can be done through multi-organ MPS in modeling complex processes to make predictions of a drug’s safety and efficacy more reliable.</span></p> <h4><b>Integrated MPS Applications in Predictive Toxicology</b></h4> <p><span style="font-weight: 400;">Applications of integrated MPS in predictive toxicology are going to change the face of drug development with more accurate and human-relevant data. These systems provide the greatest benefit through the identification of potential toxicities early in the process of drug development, reducing the risk of negative effects observed in human trials.</span></p> <p><span style="font-weight: 400;">For instance, integrated MPS can be used to evaluate the cardiotoxicity of novel drugs by simulating electrical and mechanical cardiac activities under the impacts of a drug. By including liver models, these systems will be able to examine how the metabolic processing of a drug interacts with its cardiotoxic potential. Such would aid in the filtering of early cardiotoxic compounds from development, thus reducing the possibility of later-stage failures that are usually very costly and hazardous.</span></p> <p><span style="font-weight: 400;">Aside from cardiotoxicity, this integrated MPS can be further exploited for hepatotoxicity, nephrotoxicity, and neurotoxicity testing. Intended for this kind of testing, through the replication of intricate interactions among different organ systems, the platforms will establish a much more complete concept of the drug safety profile, identifying potential toxicities that would have otherwise been missed by typical models of testing.</span></p> <p><span style="font-weight: 400;">In addition, integrated MPS can also allow the study of chronic drug exposure, as this is a very important aspect in the long-term safety evaluation of new or existing pharmaceutical compounds. Traditional in vitro models are typical only of short-term studies, although MPS can maintain tissue viability and function over lengthy periods and allow small, but cumulative, effects at levels below those of parasitic responses to be determined. These are particularly true for drugs taken chronically, say for the treatment of chronic diseases.</span></p> <h4><b>Next comes the role of Integrated MPS in Personalized Medicine</b></h4> <p><span style="font-weight: 400;">Beyond drug safety testing, integrated MPS also holds great promise for advancing personalized medicine. By utilizing the patient’s own cells combined with the MPS platform, the researchers obtained models that clearly manifest the physiology and genetics of that person. Personalized MPS can be used to screen how a given drug is likely to affect a particular patient through the idea of adverse effects and make decisions regarding treatment.</span></p> <p><span style="font-weight: 400;">For instance, personalized heart-on-chip models could be engineered using cells derived from a patient’s own induced pluripotent stem cells. Such models may be used to test the drug’s effects on the patient’s heart with better predictive value for cardiotoxicity. On the other hand, personalized liver-on-chip models can be used to assess how a patient’s liver might metabolize a certain drug, thus predicting possible drug-drug interactions or different ways of metabolism among individuals.</span></p> <p><span style="font-weight: 400;">This, in turn, opens new possibilities for drug discovery and development through the ability to create personalized MPS. Testing candidate drugs on personalized models allows the identification of compounds likely to be safe and effective under specific conditions within patients, and thus further steps may be taken toward more targeted and personalized therapies.</span></p> <p></div></div> <div style="background: #f7f7f7;border: 1px solid rgba(0, 0, 0, 0.07);"> <div style="padding: 30px;"><div class="Adblock-main"> <div class="Adblock-head"> <h2>Recent Publications on <b>“<a href="https://thepharma.net/recent-publications/index/drug safety" target="_blank" rel="noopener" title="drug safety - yearwise publication list">drug safety</a>”</b></h2> </div> </div> <div class="pb-main"><div class="article-scroll"><div id="results_recent" class="results"></div></div><div class="keywordsdiv" style="margin: 0px 15px;margin-top:20px;"> <div style="text-align:center;"><b>Find publications on relevant topics</b> </div> <span class="gp-icon icon-tags"><svg viewBox="0 0 512 512" aria-hidden="true" xmlns="http://www.w3.org/2000/svg" width="1em" height="1em"><path d="M20 39.5c-8.836 0-16 7.163-16 16v176c0 4.243 1.686 8.313 4.687 11.314l224 224c6.248 6.248 16.378 6.248 22.626 0l176-176c6.244-6.244 6.25-16.364.013-22.615l-223.5-224A15.999 15.999 0 00196.5 39.5H20zm56 96c0-13.255 10.745-24 24-24s24 10.745 24 24-10.745 24-24 24-24-10.745-24-24z"></path><path d="M259.515 43.015c4.686-4.687 12.284-4.687 16.97 0l228 228c4.686 4.686 4.686 12.284 0 16.97l-180 180c-4.686 4.687-12.284 4.687-16.97 0-4.686-4.686-4.686-12.284 0-16.97L479.029 279.5 259.515 59.985c-4.686-4.686-4.686-12.284 0-16.97z"></path></svg></span> <span id="keyword-papers"></span> </div></div></div><div class="inside-article"> <style> .pb-main{ border: solid 1px #ccc; border-top: none; margin-bottom: 20px; padding-bottom: 25px; background:#fff; } .author-main { border: solid 1px #ccc; border-top: none; margin-bottom: 20px; padding-bottom: 25px; background:#fff; } .publication-block { padding: 10px; margin-bottom: 10px; 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#a71c49; } #keyword-papers{ margin-top: 20px; text-align: center; } </style> <script> function decodeString(str) { str = str.replace(/\\'/g, "'"); str = str.replace(/\\'/g, "'"); str = str.replace(/\\'/g, "'"); return str; } function displayResults_recent(papers) { var resultsContainer = document.getElementById('results_recent'); if (!papers || papers.length === 0) { resultsContainer.innerHTML = '<p>No recent publications found.</p>'; return; } papers.forEach(paper => { var publicationBlock = document.createElement('div'); publicationBlock.className = 'publication-block'; var title_de = decodeString(paper.title); var publicationHTML = ` <div style="margin-bottom: 10px;line-height: 24px;"><a href="${paper.url}" target="_blank" title="${title_de}">${title_de}</a></div> <p><strong>Issue Release:</strong> ${paper.publishedDate}</p> `; publicationBlock.innerHTML = publicationHTML; resultsContainer.appendChild(publicationBlock); }); } function displayKeywordPapers(keywords) { var resultsContainer = document.getElementById('keyword-papers'); resultsContainer.innerHTML = ''; if (!keywords || keywords.length === 0) { resultsContainer.innerHTML = '<p>No data found.</p>'; return; } var keywordHTML = ''; keywords.forEach((key, index) => { let key_replace = key.replace(/ /g, '-'); key_replace = key_replace.toLowerCase(); keywordHTML += `<a href="https://thepharma.net/recent-publications/index/${key_replace}" target="_blank" title="${key} - publication list">${key}</a>`; if (index < keywords.length - 1) { keywordHTML += ', '; } }); resultsContainer.innerHTML = keywordHTML; } // Call the function with the PHP data var recent_papers = [ { "title": "Controlled Release of Molecules to Enhance Cell Survival and Regeneration.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/39240528", "publishedDate": "2025" }, { "title": "Retinal Explant Culture from Mouse, Human, and Nonhuman Primates and Its Applications in Vision Research.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/39240523", "publishedDate": "2025" }, { "title": "NANOSUSPENSIONS: ENHANCING DRUG BIOAVAILABILITY THROUGH NANONIZATION.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945393", "publishedDate": "2024" }, { "title": "[Pharmacological properties and clinical development overview of pertuzumab (genetical recombination), trastuzumab (genetical recombination) and vorhyaluronidase alfa (genetical recombination) (PHESGO combination for \u200dsubcutaneous injection MA, IN)].", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945908", "publishedDate": "2024" }, { "title": "Innovative approaches to cardiovascular safety pharmacology assessment.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945308", "publishedDate": "2024" }, { "title": "Characterization of two virulent Salmonella phages and transient application in egg, meat and lettuce safety.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945617", "publishedDate": "2024" }, { "title": "Effectiveness and Drug Survival of Ixekizumab and Secukinumab in Patients with Moderate to Severe Plaque Psoriasis: Real-World Data from Bucharest, Romania.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38946911", "publishedDate": "2024" }, { "title": "Systemic oncological therapy in breast cancer patients on dialysis.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38946836", "publishedDate": "2024" }, { "title": "Chlorogenic acid\/carboxymethyl chitosan nanoparticle-assisted biomultifunctional hyaluronic acid-based hydrogel scaffolds for burn skin repair.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945346", "publishedDate": "2024" }, { "title": "[Pharmacological characteristics and clinical study results of ensitrelvir fumaric acid (XOCOVA Tablets 125\u2005\u200dmg)].", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945910", "publishedDate": "2024" }, { "title": "ONC206 targeting ClpP induces mitochondrial dysfunction and protective autophagy in hepatocellular carcinoma cells.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38944913", "publishedDate": "2024" }, { "title": "Prenatal exposure to vortioxetine and vilazodone: Impact on depressive- and anxiety-like behavioral manifestations in young rat offspring.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945303", "publishedDate": "2024" }, { "title": "Comparative analysis of adverse events among intravesical drugs in bladder cancer: a real-world study on FAERS database.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38946478", "publishedDate": "2024" }, { "title": "Shared genetics between breast cancer and predisposing diseases identifies novel breast cancer treatment candidates.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38947022", "publishedDate": "2024" }, { "title": "Learning Molecular Representation in a Cell.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38947938", "publishedDate": "2024" }, { "title": "Evaluation of artificial intelligence-generated drug therapy communication skill competencies in medical education.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38953544", "publishedDate": "2024" }, { "title": "Real-World Clinical Performance of a Novolimus-Eluting Stent Versus a Sirolimus-Eluting Stent.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38953595", "publishedDate": "2024" }, { "title": "N-803 Plus BCG Treatment for BCG-Na\u00efve or -Unresponsive Non-Muscle Invasive Bladder Cancer: A Plain Language Review.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38953850", "publishedDate": "2024" }, { "title": "A Long-Term Safety and Tolerability Study of TV-46000 for Subcutaneous Use in Patients with Schizophrenia: A Phase 3, Randomized, Double-Blinded Clinical Trial.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38954317", "publishedDate": "2024" }, { "title": "Pharmacotherapeutic options for metabolic dysfunction-associated steatotic liver disease: where are we today?", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38954663", "publishedDate": "2024" } ]; var keywordsArray = ["Microphysiological Systems","Drug Safety","Predictive Toxicology","Organs-on-Chips","Multi-Organ Platforms","Personalized Medicine","Cardiotoxicity","Hepatotoxicity","and Drug Development"]; displayResults_recent(recent_papers); displayKeywordPapers(keywordsArray); // function stripslashes(str) { // if (typeof str === 'string') { // return str.replace(/\/g, ''); // } // } </script></p> <h4><b>Current Problems and Future Directions</b></h4> <p><span style="font-weight: 400;">While the advantages of MPS integration are enormous for predicting drug safety and toxicology upfront, the integration also presents several challenges. Among them, the capability of real human physiology is complex. While the MPS can replicate most of the functions of the human organs, they still remain very simplified in comparison to the conditions of the real human body. Further research and development needs to be undertaken to improve the precision and accuracy of these systems.</span></p> <p><span style="font-weight: 400;">Another challenge related to MPS technology is the aspect of scalability and standardization. To attain broad application in the pharmaceutical industry, MPS platforms must be scalable, cost-effective, and user-friendly. Though efforts have already been initiated to develop standardized protocols and platforms that could be integrated into current drug development workflows, more work is needed so that those systems work very consistently and reliably in different labs and applications.</span></p> <p><span style="font-weight: 400;">Finally, there is a lack of more extensive validation of MPS technology itself. While MPS has been very promising in studies performed at the preclinical level, further investigations are required to establish its predictive power for real-world scenarios of drug development. This will require collaboration among academics, industry experts, and regulatory agencies working together to set up benchmarks and guidelines for the application of MPS in drug safety testing.</span></p> <h4><b>Conclusion</b></h4> <p><span style="font-weight: 400;">Such integration affords a powerful tool for the rigorous assessment of the safety and efficacy of new pharmaceutical compounds by integrating models of multiple organs on one platform. The future of drug safety is the integration of enhanced microphysiological systems that more closely mimic human physiology and pharmacology. It is also expected that such systems should limit the adverse effects of human trials, facilitate drug development processes, and lead to more individualized and specific treatment opportunities.</span></p> <p><span style="font-weight: 400;">It is in this sector that integrated MPS will become core technology in the near future, with research and development showing no signs of slowing down. Even with the challenges that remain, the potential benefits are enormous, opening a new paradigm for drug development that is more accurate, efficient, and relevant to humans than ever before.</span></p> <p></p> <h4><b>References</b></h4> <ol> <li>Visone, R., Ugolini, G.S., Cruz-Moreira, D., Marzorati, S., Piazza, S., Pesenti, E., Redaelli, A., Moretti, M., Occhetta, P. and Rasponi, M., 2021. <a href="https://iopscience.iop.org/article/10.1088/1758-5090/abe4c4/meta">Micro-electrode channel guide (µECG) technology: an online method for continuous electrical recording in a human beating heart-on-chip.</a> <i>Biofabrication</i>, <i>13</i>(3), p.035026.</li> <li>Yin, F., Zhang, X., Wang, L., Wang, Y., Zhu, Y., Li, Z., Tao, T., Chen, W., Yu, H. and Qin, J., 2021. <a href="https://pubs.rsc.org/en/content/articlelanding/2020/lc/d0lc00921k/unauth">HiPSC-derived multi-organoids-on-chip system for safety assessment of antidepressant drugs.</a> <i>Lab on a Chip</i>, <i>21</i>(3), pp.571-581.</li> <li>Lu, R.X.Z., Lai, B.F.L., Benge, T., Wang, E.Y., Davenport Huyer, L., Rafatian, N. and Radisic, M., 2021. <a href="https://onlinelibrary.wiley.com/doi/abs/10.1002/admt.202000726">Heart‐on‐a‐chip platform for assessing toxicity of air pollution related nanoparticles.</a> <i>Advanced Materials Technologies</i>, <i>6</i>(2), p.2000726.</li> <li>Chramiec, A., Teles, D., Yeager, K., Marturano-Kruik, A., Pak, J., Chen, T., Hao, L., Wang, M., Lock, R., Tavakol, D.N. and Lee, M.B., 2020. <a href="https://pubs.rsc.org/en/content/articlelanding/2020/lc/d0lc00424c/unauth">Integrated human organ-on-a-chip model for predictive studies of anti-tumor drug efficacy and cardiac safety. </a><i>Lab on a Chip</i>, <i>20</i>(23), pp.4357-4372.</li> <li>Ferrari, E., Palma, C., Vesentini, S., Occhetta, P. and Rasponi, M., 2020. <a href="https://www.mdpi.com/2079-6374/10/9/110">Integrating biosensors in organs-on-chip devices: A perspective on current strategies to monitor microphysiological systems. </a><i>Biosensors</i>, <i>10</i>(9), p.110.</li> <li>Lee-Montiel, F.T., Laemmle, A., Dumont, L., Lee, C.S., Huebsch, N., Charwat, V., Okochi, H., Hancock, M.J., Siemons, B., Boggess, S.C. and Goswami, I., 2020. <a href="https://www.biorxiv.org/content/10.1101/2020.05.24.112771v2.abstract">Integrated hiPSC-based liver and heart microphysiological systems predict unsafe drug-drug interaction.</a> <i>BioRxiv</i>, pp.2020-05.</li> <li>Skardal, A., Aleman, J., Forsythe, S., Rajan, S., Murphy, S., Devarasetty, M., Zarandi, N.P., Nzou, G., Wicks, R., Sadri-Ardekani, H. and Bishop, C., 2020. <a href="https://iopscience.iop.org/article/10.1088/1758-5090/ab6d36/meta">Drug compound screening in single and integrated multi-organoid body-on-a-chip systems.</a> <i>Biofabrication</i>, <i>12</i>(2), p.025017.</li> </ol> <p></div></div> <div style="background: #f7f7f7;border: 1px solid rgba(0, 0, 0, 0.07);"> <div style="padding: 30px;"><div class="Adblock-main"> <div class="Adblock-head"> <h2>Top Experts on “<b style="color:#000;font-size:22px;">drug safety</b>“</h2> </div> </div><div class="author-main"><div id="results_author"></div><div style="text-align: center;"><a class="register-button" href="https://thepharma.net/expert-search" target="_blank" rel="noopener">Find experts on any field</a></div></div><div class="inside-article" style="background: none;border: none;box-shadow: none;margin-top: -70px;"> <style> .author-block { padding: 15px; 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