Drug Management Research Articles

Harnessing Artificial Intelligence in Generic Formulation Development and Life Cycle Management - A Comprehensive Review

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.

Metronidazole is a chromatographic interference on a routine HPLC-UV assay for thiopurine metabolites.

Background Thiopurine metabolites, 6-thioguanine (6TG) and 6-methylmercaptopurine (6MMP), are monitored to aid therapeutic management of thiopurine drugs. At Manchester University NHS Foundation Trust (MFT), thiopurine metabolites are measured by high performance liquid chromatography with ultraviolet detection (HPLC-UV). Whole blood samples are lysed and subjected to hydrolysis with derivatisation of 6MMP before HPLC-UV detection at 304nm for the 6MMP-derivative and 342nm for 6TG. For some samples, 6MMP cannot be reported due to a chromatographic interference at 304nm co-eluting with the 6MMP peak. An investigation was performed to identify the interfering compound. Methods Patient medication histories were examined to identify candidate compounds for the interference. Candidate compounds were spiked into blood at supraphysiological concentrations and tested on the assay. Results Metronidazole was identified as being prescribed to all patients whose samples demonstrated the interference. Metronidazole and its metabolite, hydroxymetronidazole, were spiked into blood. HPLC-UV analysis of spiked blood demonstrated similar UV absorbance patterns to those seen in patient samples with the interference. Hydroxymetronidazole co-eluted with 6MMP causing interference in the measurement. Conclusion Metronidazole and its major metabolite can interfere with 6MMP measurement by HPLC-UV analysis at 304 nm.

Management of Systemic Anti-psoriatic Drugs in PsoriasisPatients with ConcurrentParaplegia or Tetraplegia: Insights From a 6-Year Multicenter, Retrospective Observational Study.

Patients with psoriasis (PsO) and permanent spinal cord injuries (SCI) resulting in paraplegia and tetraplegia may experience a higher rate of infections compared to patients with PsO without SCI. It can result in further challenges for therapeutic management with immunosuppressants (biological and non-biological treatments). Thus, weaimed to evaluate the rate of infections in patients with PsO and SCI treated with systemic immunosuppressants. This multicenter, retrospective observational study enrolled patients with PsO and traumatic SCI undergoing systemic immunosuppressive treatments for at least 5years. All patients were evaluated by experienced, board-certified dermatologists and neurologists. Demographic and clinical data were collected. We enrolled 23 patients with SCI (16 with paraplegia and 7 with tetraplegia) treated with methotrexate (MTX) and different biologics (tumor necrosis factor (TNF) inhibitors (i) and interleukin (IL)-17i/IL-23i). Globally, patients with SCI treated with MTX displayed higher rates of infection compared to those treated with biologics. Patients with paraplegia had lower rates of infection compared to patients with tetraplegia during anti-psoriatic therapies (p < 0.05). Those treated with TNFi had greater rates of infection than those treated with IL-17i/IL-23i (p < 0.001). Patients with psoriatic arthritis (PsA) experienced a significant diagnostic delay and clinical monitoring of PsA severity was challenging. In patients with moderate-to-severe PsO and concurrent traumatic SCI, dermatologists should consider using IL-17i/IL-23i as first-line therapy.

Intrinsic fluorescence hydrogels for ON/OFF screening of antidiabetic drugs: assessing α-glucosidase inhibition by acarbose.

Diabetes remains one of the most prevalent chronic diseases globally, significantly impacting mortality ratetables. The development of effective treatments for controlling glucose level in blood is critical to improve the quality of life of patients with diabetes. In this sense, smart optical sensors using hydrogels, responsive to external stimuli, have emerged as a revolutionary approach to diabetes care. In this study, changes in the optical properties of a hydrogel are employed for monitoring α-glucosidase activity, a critical enzyme involved in diabetes mellitus type II due to its role in breaking terminal α-glycosidic bonds, releasing α-glucose. The enzyme is encapsulated within a triazine-based hydrogel that exhibits intrinsic blue fluorescence. Upon hydrolysis of the substrate p-nitrophenyl-α-D-glucopyranoside (p-NPG) by α-glucosidase, the fluorescence is quenched due to the release of p-nitrophenol (PNP). However, when exposed to potential antidiabetic drugs, the enzyme's activity is inhibited, and the hydrogel's fluorescence remains intact. This ON/OFF fluorescence-based assay enables rapid screening of drug candidates by evaluating their ability to inhibit α-glucosidase enzymatic activity. Sensor optimization involves conducting swelling studies, fluorescent assays, reusability tests and a trial with a real antidiabetic drug. This innovative approach holds potential for enhancing antidiabetic drug screening and management, offering a more accessible and efficient solution compared to traditional biosensors.

P0185 Prevalence of IBS-like symptoms in Ulcerative Colitis patients in clinical remission

Abstract Background Irritable bowel syndrome (IBS) is a common gastrointestinal disorder with a higher prevalence in patients with inflammatory bowel disease (IBD) compared to the general population. Ulcerative colitis (UC) patients frequently report symptoms such as abdominal discomfort, bloating, altered bowel habits, and worsening symptoms due to foods or stress, even during clinical remission. This study examines the prevalence of IBS-like symptoms in UC patients at an IBD clinic in a London teaching hospital. Methods A survey among 100 UC patients included those with active disease (flare) and in remission. Remission status was defined by: (1) faecal calprotectin levels ≤250µg/g in the last year, (2) C-reactive protein (CRP) within the normal range in the past six months, and (3) a Mayo score of 0 on a flexible sigmoidoscopy/colonoscopy within 6 months. The IBS information questionnaire was based on WHO criteria1 and included 16 questions. Data collected included disease location, year of diagnosis, gender, and current treatment. Results Among the 100 patients, 34% had active disease and 66% were in remission during time of survey completion and 91% on active drug management. Total symptom scores differed significantly between active and remission groups (p=0.0066), with higher scores in active disease. However, 94% of patients in remission reported 1&amp;lt; symptom and the mean total score was 11.32 (SD ~6.08) indicating persistent symptoms. There is a female preponderance in symptoms scores than males in both active and remission states. In active disease, females had a mean score of 16.67 (SD: 5.91) vs males at 11.53 (SD: 5.66); in remission, females scored 11.77 (SD: 5.96) vs males at 9.59 (SD: 5.56). A statistically significant gender difference was found in active disease (p=0.0144) but not in remission (p=0.129). Table 1 shows symptoms reported in remission. Bloating correlated with constipation (r=0.32, p=0.008), potentially indicating proximal constipation in UC remission. Additionally, loose stools were strongly correlated with bowel urgency (r=0.73, p=&amp;lt;0.0001), suggesting a symptom cluster. Among remission patients, proctitis showed the highest scores, while pancolitis scored the lowest. Disease location was weakly negatively correlated with symptom scores (r=-0.19, p=0.76), as was time since UC diagnosis (r=-0.13, p=0.305). Conclusion This study shows that IBS-like symptoms persist in UC patients during remission, with 94% reporting 1&amp;lt; symptom despite active drug management. Symptom clusters such as loose stools and bowel urgency and gender differences, emphasise the need for tailored, symptom-focused care. Comprehensive strategies are essential to address residual symptoms and improve quality of life for UC patients, even in remission.

Plant-derived Pembrolizumab in conjugation with IL-15Rα-IL-15 complex shows effective anti-tumor activity.

Anti-programmed cell death 1 (PD-1) monoclonal antibodies (mAbs) have proven to be effective in treating various cancers, including colorectal, lung, and melanoma. Despite their clinical success, some patients develop resistance to mAbs, requiring co-treatments with radio- or chemotherapy. Interleukin-15 (IL-15) is an immunostimulatory cytokine that promotes immune cell production and proliferation. It has been combined with mAbs and other immunotherapies to improve efficacy and reduce side effects. Fusion of anti-PD-1 mAb and IL-15 streamlines drug administration and management. In this study, we developed a prototype by conjugating the IL-15 receptor subunit alpha (IL-15Rα) and IL-15 complex to the C-terminus of anti-PD-1 Pembrolizumab (Pembrolizumab-IL-15Rα-IL15) using plant molecular farming for production. LC-MS revealed the presence of plant N-glycans (GnGnXF, GnXF and Man9GlcNAc2) on the molecule, which may affect receptor-binding avidity. However, ELISA demonstrated comparable binding efficacy of Pembrolizumab-IL-15Rα-IL15 to human PD-1 protein as commercial Pembrolizumab. In a mouse anti-cancer study, Pembrolizumab-IL-15Rα-IL15 (3 mg kg-1) exhibited slightly improved tumor-growth inhibition, reducing tumor size by 94% compared to commercial Pembrolizumab (5 mg kg-1) with an 83% reduction, regardless of statistically significant difference. In conclusion, Pembrolizumab-IL-15Rα-IL-15 was successfully produced using plant molecular farming and shows promise in addressing mAb drug resistance and enhancing the immunomodulatory effects of IL-15 payload.

Discussion on the optimization of personalized medication using information systems based on pharmacogenomics: an example using colorectal cancer.

Pharmacogenomics (PGx) is a powerful tool for clinical optimization of drug efficacy and safety. However, due to many factors affecting drugs in the real world, PGx still accounts for a small proportion of actual clinical application scenarios. Therefore, based on the information software, pharmacists use their professional advantages to integrate PGx into all aspects of pharmaceutical care, which is conducive to promoting the development of personalized medicine. In this paper, the establishment of an information software platform is summarized for the optimization of a personalized medication program based on PGx. Taking colorectal cancers (CRC) as an example, this paper also discusses the role of PGx in different working modes and participation in drug management of CRC patients by pharmacists with the help of information systems. Finally, we summarized the recommendations of different PGx guidelines to provide reference for the follow-up personalized pharmaceutical care.

Interprofessional Education in Healthcare: Benefits, Challenges, and Impacts on Drug Management and Patient Care

Interprofessional education (IPE) is an integral component of healthcare training that encourages close working relationships among different healthcare professionals. Driven by its curriculum goal of integrating students from diverse fields like medicine, pharmacy, nursing and allied health to emphasize the development of key competencies for participation in teams and medication management, this approach brings students from all these fields together. IPE exposes students to common learning experiences which help students learn about their roles and responsibilities in patient care. Research indicates that collaborative learning environments not only serve to increase the knowledge that participants have of drug therapy but also aid in improving patient outcomes by decreasing medication errors as well as promoting patient-centric care. The IPE's impact on collaborative practice was discussed, with specific attention to the role played by medical education on medication management and patient outcomes.

Real-world studies of crizotinib in patients with ROS1-positive non-small-cell lung cancer: experience from China.

The treatment of non-small-cell lung cancer (NSCLC) has progressed from histology-oriented cytotoxic therapy to the era of molecular biology-oriented targeted therapy and immunotherapy. As the first tyrosine kinase inhibitor (TKI) targeting the ROS1 pathway, crizotinib is widely used as a first-line regimen for ROS1-rearranged NSCLC. However, due to the paucity of solid data from randomized, controlled phase III clinical studies, clinicians often require more systematic, real-world data-based guidance for its optimal clinical use. As one of the leading countries of real-world research on crizotinib, China has contributed significantly to data on standardization of the therapeutic use of crizotinib, including its clinical treatment patterns, the timing and duration of treatment and drug resistance monitoring and management.

The Influence of Education on The Level of Knowledge and Behavior about the Antibiotic for Lectureres at Sahid University Surakarta

The problem of drug misapplication is a case that still often encountered in society. Many people buy potent drugs without a doctor's prescription. Lack of knowledge in knowing the side effects of drugs, storing drugs and disposing of unused drug waste to be destroyed first causes many cases of medication errors to occur, thus increasing ineffectiveness in drug administration therapy. The aim of the research was to determine the profile of drug storage and disposal, family members of Sahid University Surakarta lecturers in drug management at home, the quality profile of drug management, and analyze the factors that influence drug management at home and their effects after being given the correct used antibiotics education. This research uses a pre-experimental design method with a pretest/posttest intervention design without control group, sampling for this research uses a purposive sampling technique. The sample for this research were lecturers at Sahid University of Surakarta in accordance with the inclusion and exclusion criteria that had been determined with a total of 20 respondents. The results of the research show that the results of the Wilcoxon Test have a p value = 0.000 (p&lt;0.05). This shows that providing antibiotics medicine education influences the level of knowledge and behavior of the lecturers at Sahid University of Surakarta regarding drug use. The conclusion of this research showing that there is a need to disseminate knowledge about used antiobiotics medicine especially regarding antibiotic drugs, so that the public understands better how to use drugs properly and correctly.

The increasing role of the allergist in the management of infusion reactions at the Oncology Infusion Center.

Hypersensitivity reactions to chemotherapy disrupt treatment schedules and compromise patient outcomes. Rapid Drug Desensitization (RDD) enables patients to tolerate future treatments after an allergy workup. However, Same-Day Desensitization (SDD) is a novel approach that capitalizes on RDD to allow the continuation of chemotherapy on the same day as the index reaction, preventing treatment delays. To evaluate the safety and efficacy of SDD in managing hypersensitivity reactions during chemotherapy and emphasize the essential role of allergists in the Oncology Infusion Center (OIC) for accurate drugs hypersensitivity reactions (DHRs) phenotyping and management. This retrospective cohort included patients experiencing DHRs during chemotherapy. Under allergist supervision, SDD was performed once the index reaction was controlled. At a later date, clinical phenotypes and endotypes of DHRs were assessed through clinical history, skin tests, serum biomarkers (including tryptase and IL-6 levels), and drug provocation testing (DPT) to reach an accurate diagnosis. SDD was successful in 35 cases, even for patients with severe initial reactions. Only 14% experienced breakthrough reactions, all mild. Same-day assessment by allergists ensured a 92% correlation between initial and final diagnoses, optimizing DHR management. Early engagement with Allergy allowed 86% of reactive patients to continue treatment through RDD or after ruling out an allergy. SDD is a safe and effective procedure that ensures that patients don't miss their oncology treatment on the day of a reaction. The presence of an allergist in the OIC is crucial for rapid access to accurate DHR phenotyping and optimal management, supporting personalized precision medicine in oncology.

Genomic Insights into Rheumatoid Arthritis through computational Profiling for Hub Genes

Rheumatoid arthritis (RA) is a complex autoimmune disorder predominantly affecting joints, with its etiology and response to treatment still not fully understood despite extensive historical documentation. This study aims to shed light on the differentially expressed genes (DEGs) associated with RA progression, potentially identifying new drug targets and management strategies. This study analyzed gene expression data (GSE193193) from the Gene Expression Omnibus (GEO) database, identifying 3672 significant DEGs out of 36107 initially retrieved genes. Among these, 283 genes were up-regulated and 360 were down-regulated. Gene enrichment analysis was performed to uncover relevant gene ontology terms and pathways. Subsequently, network construction and analysis, along with hub gene prediction using Cytoscape's MCODE and CytoHubba plugins, were conducted. Key genes identified in this study include HBB, ALAS2, GATA1, AHSP, HBG1, HBG2, HBD, KLF1, SLC4A1, EPB42, ZMYND10, DNAJC7, HYDIN, LRRC6, FN1, NCAM1, FASLG, CTCF, SMAD4, and STAT1. These genes are implicated not only in RA but also in other diseases, presenting them as potential therapeutic targets. Additionally, three transcription factors (GATA1, NFKB1, and RELA) and one miRNA (has-mir-27a-3p) were identified as key regulators of these hub genes. In conclusion, this study not only enhances our understanding of the molecular mechanisms underlying RA but also identifies several critical DEGs and regulatory factors that could serve as promising targets for therapeutic intervention. The identification of these genes and regulatory elements paves the way for the development of targeted treatments, which could significantly improve disease management and patient outcomes. Future research focusing on these identified targets may lead to innovative strategies for combating RA and potentially other autoimmune disorders, thereby offering new hope to patients affected by these conditions.

ANALISIS TINGKAT PEMAHAMAN PENGELOLAAN OBAT BAGI TENAGA KESEHATAN BERDASARKAN PERMENKES NO 26 TAHUN 2020

Drug management is an activity that plays an important role in health development. This activity starts from the process of planning, requesting, receiving, storing, distributing, sorting, controlling, administering and monitoring and evaluating. This study aims to analyze the knowledge of health workers from several health centers in the Central Lombok Regency area about the drug management system based on Permenkes Number 26 of 2020. This study uses a qualitative descriptive method which aims to analyze the level of knowledge of health workers at puskesmas in the Central Lombok Regency area. Qualitative data was obtained from direct interviews with health workers, especially pharmaceutical workers who work in Central Lombok health centers. The results showed that the level of knowledge of health workers in the drug management process was quite good. The results of knowledge on the drug management process show that most of the indicators covering the process of receiving and distributing have reached 83% - 87% in the “Very Good” category while in the process of planning, requesting, storing, destroying, controlling, administering and monitoring and evaluating are still in the “Good” category with a value of 61% - 74%. It can be concluded that the knowledge of health workers at health centers in the Central Lombok Regency area as a whole is in the “Good” category and has been carried out according to Permenkes No. 26 of 2020.

CYP3A4 drug metabolism considerations in pediatric pharmacotherapy

AbstractCytochrome P450 3A4 (CYP3A4) is a crucial enzyme involved in the Phase I metabolism of numerous medications used in clinical practice. Its potential significance in pediatric pharmacotherapy is underscored by the unique metabolic profile of children, which differs markedly from adults, especially in neonates, infants, and young children due to developmental changes in enzyme activity. This review explores the critical role of CYP3A4 in the metabolism of drugs used in the pediatric population, with a particular focus on combination drug therapies. Given the high potential for drug-drug interactions in combination therapies, understanding the modulation of CYP3A4 activity is essential for optimizing therapeutic outcomes and minimizing adverse effects. This paper further examines the structural similarities between these medications and bergamottin, a known CYP3A4 inhibitor found in citric fruits such as grapefruit. Variability in CYP3A4 activity, influenced by genetic polymorphisms, developmental stage, and external factors, necessitates careful consideration in the prescribing and management of drugs in children. This review corroborates the need for personalized medicine approaches and enhanced pharmacovigilance to ensure the safe and effective use of CYP3A4-metabolized drugs in the pediatric population. Graphical Abstract

PERANCANGAN SISTEM INFORMASI MANAJEMEN DATA OBAT BERBASIS WEB DI UPTD INSTALASI FARMASI DINAS KESEHATAN KOTA JAMBI

The programming language used in this web development is PHP using the Laravel framework and the RDBMS used is MySQL. The system development model used is the SDLC waterfall model so that the work is gradual and more structured. This research resulted in web-based drug management at the Jambi City Pharmaceutical Installation UPTD being able to solve the problem of recording incoming drugs from Pharmaceutical Wholesalers, Submission of LPLPO files by Puskesmas as official proof of drug needs at the Puskesmas, outgoing drugs during drug distribution activities to Puskesmas, data on Pharmaceutical Wholesalers who partner as drug suppliers at the Jambi City. Health Office Pharmaceutical Installation UPTD Warehouse, data on health centers in Jambi City along with officers who will come during distribution and drug data that will be returned to the Pharmaceutical Wholesaler responsible for the product.

Synergistic Collaboration of Pharmacists and Nurses in Enhancing Patient Care

Collaboration between pharmacists and nurses is widely seen as an important synergistic collaboration in enhancing patient care by addressing issues such as drug mistakes, growing healthcare expenditures, and complex illness management. Their combined expertise enhances patient care by optimizing drug therapy, improving patient education, and reducing preventable medication-related issues. This article reflects the synergistic collaboration of pharmacists and nurses in enhancing patient care. A literature analysis was done to investigate research on multidisciplinary interaction between pharmacists and nurses in diverse healthcare settings, with an emphasis on their roles in drug management, patient education, and therapy optimization to reduce any avoidable interactions. Collaboration dramatically lowers medication mistakes, increases patient adherence, and improves overall clinical results, including chronic disease management. Despite the benefits, communication gaps and ambiguous responsibilities hinder successful synergistic collaboration. Addressing these hurdles through improved training and integration of certain healthcare systems software for better collaboration is critical to maximize the advantages of this collaborative effort. Pharmacist-nurse collaboration improves patient care and safety, and overcoming current obstacles can lead to more efficient, patient-centered healthcare systems. Despite the great perks of collaboration, there are certain obstacles to smooth collaborations. These obstacles can be addressed by providing proper training and integration of AI and other technical software for a smooth collaboration. With the partnership between pharmacists and nurses, much scope will be realized to improve patient-centered care. The removal of present obstacles and incitement of closer collaboration will make it possible for healthcare systems to improve clinical results, lower prescription errors, and guarantee more effective and patient-focused care delivery.

Pregnancy in patients with chronic kidney disease undergoing dialysis.

Women with chronic kidney disease are less likely to become pregnant and are more susceptible to pregnancy complications when compared to patients with normal kidney function. As a result, these are considered high-risk pregnancies, both maternal and fetal. Over the years, there has been an increase in the incidence of pregnancies in dialysis patients, and an improvement in maternal and fetal outcomes. It is believed that the optimization of obstetric and neonatal care, the adjustment of dialysis treatment (particularly the increase in the number of hours and weekly frequency of dialysis sessions), and the use of erythropoiesis-stimulating agents have provided better metabolic, volume, blood pressure, electrolyte, and anemia control. This review article aims to analyze pregnancy outcomes in chronic kidney disease patients undergoing dialysis and to review nephrological medical management in this scenario. Due to the growing interest in the subject, clinical recommendations for care practice have become more consistent in both drug and dialysis management, aspects that are addressed in this review.

Perancaangan Sistem Informasi Apotik Berbasis Web: Optimalisasi Layanan Pelanggan

This research discusses the development and implementation of a "Web-Based Pharmacy Information System" which aims to improve the efficiency of customer service and drug inventory management. By using web technology, PHP programming language, and MySQL database, this system allows pharmacies to monitor drug stocks in real-time, manage patient information, and provide integrated services. The use of PHP and MySQL in developing this application allows the automation of administrative tasks, including drug stock tracking, orders, and patient data management. This system also facilitates customer service with easy access to drug information and online drug ordering services. The research results show that the implementation of the Web-Based Pharmacy Information System has succeeded in increasing pharmacy efficiency, reducing drug stock shortages, and improving customer service. This system supports integrated drug management by integrating patient data, drug stock and customer service in one platform. Overall, this system illustrates how the use of web, PHP, and MySQL technologies can optimize customer service and medication inventory management in the pharmacy context, providing major benefits to pharmacies and patients.

Challenges and Strategies for Mainstreaming Neglected Tropical Diseases Campaign Interventions in Ethiopia.

Mainstreaming neglected tropical diseases (NTDs) interventions in national health systems is one of the key strategies emphasized in the WHO Roadmap for NTDs. However, there is limited evidence on implementing the proposed mainstreaming approaches effectively. We used a participatory ranking methodology in Ethiopia, using consultative workshops with purposively selected stakeholders, including NTDs program leaders from the government and partners, primary health care (PHC) workers, and community leaders and volunteers. Our aim was to identify, rank, and contextualize mainstreaming challenges and strategies, which were then synthesized using the Primary Health Care Performance Initiative framework. Thirty-three stakeholders at the national, regional, district, PHC, and community levels participated in two consultative workshops conducted in the Adama and Shashemene towns in Ethiopia. The stakeholders identified 73 mainstreaming challenges related to service delivery (32 [43.8%]), inputs (22 [30.1%]), systems (18 [24.7%]), and outputs (1 [1.4%]). The top three most frequently cited and ranked challenges were poor data recording and reporting, poor drug management and logistics, and weak supportive supervision and monitoring. Among the 185 strategies identified to address these challenges, the three most frequently cited were establishing a strong, supportive supervision and monitoring system, continuous on-the-job training to build workforce competence, and performance-based motivation. Multifaceted NTDs campaign intervention mainstreaming challenges that are deep-rooted in the health system were identified. The suggested strategies to address them should be given due consideration not only to guide future mainstreaming efforts but also to facilitate health system strengthening.

The Use of Tissue Concentrations of Biological and Small-Molecule Therapies in Clinical Studies of Inflammatory Bowel Diseases.

The introduction of biological therapies has revolutionized inflammatory bowel disease (IBD) management. A critical consideration in developing these therapies is ensuring adequate drug concentrations at the site of action. While blood-based biomarkers have shown limited utility in optimizing treatment (except for TNF-alpha inhibitors and thiopurines), tissue drug concentrations may offer valuable insights. In antimicrobial therapies, tissue concentration monitoring is standard practice and could provide a new avenue for understanding the pharmacokinetics of biological and small-molecule therapies in IBD. Various methods exist for measuring tissue concentrations, including whole tissue sampling, MALDI-MSI, microdialysis, and fluorescent labeling. These techniques offer unique advantages, such as spatial drug-distribution mapping, continuous sampling, or cellular-level analysis. However, challenges remain, including sampling invasiveness, heterogeneity in tissue compartments, and a lack of standardized bioanalytical guidelines. Drug pharmacokinetics are influenced by multiple factors, including molecular properties, disease-induced changes in the gastrointestinal tract, and the timing of sample collection. For example, drug permeability, solubility, and interaction with transporters may vary between Crohn's disease and ulcerative colitis. Research into the tissue concentrations of drugs like anti-TNF agents, ustekinumab, vedolizumab, and tofacitinib has shown variable correlations with clinical outcomes, suggesting potential roles for tissue concentration monitoring in therapeutic drug management. Although routine clinical application is not yet established, exploring tissue drug concentrations may enhance understanding of IBD pharmacotherapy.