Clinical Drug Monitoring Research Articles

Blueness, Whiteness, and greenness Appraisal of sensitive chromatographic approach for determination of semaglutide concurrently with Pioglitazone and metformin using green mobile Phase; alongside with pharmacokinetic study

The replacement of hazardous solvents with greener alternatives was under consideration to achieve a sustainable and green approach. The assessment of reliable white analytical method for the determination of semaglutide as a novel member in glucagon-like peptide agonists class is still of a great importance. That is because pharmacological, clinical, and therapeutic drug monitoring purposes. This research proposes and fully validates a simple and sensitive RP-HPLC method for the determination of semaglutide simultaneously with pioglitazone and metformin. The suggested procedures utilizing a green mobile phase of 8 % glycerol in 0.01 M phosphate buffer (pH 6). Separation was achieved using a cyano (5.0 μm, 150 × 4.6 mm) column maintained at a temperature of 40 °C. The mixture was isocratically eluted under a flow rate of 1 mL/min with a total run time of less than 8 min. The UV-detector was adjusted at 215 nm. The method provides low detection (ranging from 0.003 to 0.63 µg/mL) and quantification (ranging from 0.008 to 1.9 µg/mL) limits, with good precision (%RSD ranging from 0.66 % to 0.89 %). The suggested technique has been effectively used to determine each drug in its pharmaceutical preparation and spiked human plasma. Beside the remarkable sensitivity and sustainability of the evolved approach, the relevance of therapeutic drug monitoring motivated us to perform a pharmacokinetics study for both semaglutide and metformin in real human plasma samples. Greenness, whiteness and blueness assessment of the developed method have been carried out using different tools (Green Analytical Procedure Index (GAPI), the analytical GREEnness metric approach (AGREE), RGB-12 model and BAGI). The proven green and white profile of the evolved method could open future prospective for the clinical research and regular quality control examination of the investigated mixture with the least negative environmental impacts.

Anthracycline-induced arrhythmias in breast cancer therapy: A meta-analysis of single-arm trials.

As of 2020, breast cancer has emerged as the predominant cause of cancer incidence globally. Anthracycline-based chemotherapy serves as a crucial element in the treatment regimen for breast cancer. However, these anthracycline-based drugs are associated with cardiac toxicity. This study represents the first clinical quantitative analysis aimed at accurately determining the incidences of arrhythmia and abnormal electrocardiogram (ECG) changes, thereby providing valuable data to bolster clinical drug usage and monitoring. A systematic search was conducted across multiple databases including CNKI, VIP, Wanfang, PubMed, Embase, Web of Science, and the Cochrane Library. The incidence of combined arrhythmias in breast cancer patients and the associated heterogeneity were calculated using either a random effect model or a fixed effect model. Statistical analysis was performed using STATA16. The study encompassed a total of 37 articles, which included 5705 breast cancer patients undergoing anthracycline treatment. Among these patients, 2257 developed arrhythmias. The meta-analysis revealed that the incidence of anthracycline-associated arrhythmias and abnormal ECG changes in breast cancer patients was 0.41 (0.37, 0.44). Subgroup analysis indicated that the incidence of ST-T segment change was 0.19 (0.15, 0.23), the incidence of conduction block was 0.04 (0.02, 0.05), the incidence of premature beats was 0.09 (0.07, 0.11), and the incidence of atrial fibrillation was 0.04 (0.00, 0.12). Additional results are presented in Table 3. This pioneering study accurately assesses the incidence of arrhythmias in breast cancer patients treated with anthracyclines. The findings provide clinicians with valuable insights into understanding and managing the cardiac toxicity associated with such treatment. Moreover, this study lays the foundation for future research exploring the mechanisms underlying these arrhythmias and potential preventative strategies.

Electrochemical Sensors, Biosensors, and Optical Sensors for the Detection of Opioids and Their Analogs: Pharmaceutical, Clinical, and Forensic Applications

Pharmaceutical opioids are intravenously or orally administered analgesics. While they are effective in relieving chronic and acute pain, their narrow window of therapeutic use contributes to the high occurrence of abuse. The associated abuse of this family of drugs can be correlated to the increase in dependency, overdose, and death of users. The negative effects of opioids extend beyond the physical and psychological effects experienced by the user to their unregulated synthesis and sale, which contribute to socioeconomic challenges and are a biproduct of this global public health epidemic. From clinical to point-of-care applications, the detection and real-time monitoring of this family of drug is critical in the fight to decrease abuse and improve use in clinical settings. Chromatographic separations and chromatography–mass spectrometry are traditional methods of opioid analyses, but the high cost, long analysis time, and absence of portability highlight the need for the development of fast, in situ, point-of-care analysis, or of community drug monitoring services. This review highlights recent electrochemical and optical (FTIR, Raman, colorimetric, and fluorescent) advances and biosensors for pharmaceutical and illicit opioid analysis. Specifically, an emphasis is placed on the detection of opioids and their metabolites in biological samples and in vitro cellular assays for clinical diagnosis and forensic applications. The challenges and prospects of the role of electrochemical sensors, biosensors, and optical sensors for opioid analysis in promoting clinical diagnosis, forensic study, point-of-care, and community drug monitoring services to reduce harm are also provided.

Determination of Aminophylline in Human Serum Using Hydrogel Microspheres for Coupled Surface-Enhanced Raman Spectroscopy (SERS) and Solid-Phase Extraction.

Aminophylline (AMP) is a bronchodilator. The therapeutic and toxic doses are very close. Therefore, therapeutic drug monitoring (TDM) of AMP is essential in clinical practice. Microgels were synthesized by free radical precipitation polymerization. Silver@poly(N-isopropyl acrylamide) (Ag@PNIPAM) hybrid microgels were obtained by loading silver (Ag) nanoparticles into the three-dimensional network of the microgels by in situ reduction. The microgel is a three-dimensional reticular structure with tunable pore size, large specific surface area, and good biocompatibility, which can be used as a sorbent for solid-phase extraction (SPE) of target molecules in complex matrices and as a surface-enhanced Raman spectroscopy (SERS) substrate. We optimized the conditions affecting SERS enhancement, such as silver nitrate (AgNO3) concentration and SPE time, according to the SERS strategy of Ag@PNIPAM hybrid microgels to achieve label-free TDM for trace AMP in human serum. The results showed good linearity between the logarithmic concentration of AMP and its SERS intensity in the range of 1-1.1 × 102 µg/mL, with a correlation coefficient (R2) of 0.9947 and a low detection limit of 0.61 µg/mL. The assay accuracy was demonstrated by spiking experiments, with recoveries ranging from 93.0 to 101.8%. The method is rapid, sensitive, reproducible, requires simple sample pretreatment, and has good potential for use in clinical treatment drug monitoring.

Stepwise Introduction of Elexacaftor-Tezacaftor-Ivacaftor in Patients With Cystic Fibrosis and Liver Cirrhosis Child-Pugh A or B Using Clinical and Therapeutic Drug Monitoring: A Case Series

Cystic fibrosis (CF) is a monogenetic disease caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein and affecting multiple organs, including the lungs and liver. Almost 90% of people affected carry at least 1 Phe508del CFTR mutation. Medical treatment with the CFTR-modulating drug elexacaftor-tezacaftor-ivacaftor (ETI) has been proven to be efficacious in carriers of at least 1 Phe508del CFTR mutation. Use of ETI in patients with CF (pwCF) and liver cirrhosis is still controversial. Therefore, stepwise introduction of ETI in pwCF and liver cirrhosis Child-Pugh A or B was evaluated using clinical and therapeutic drug monitoring. Seven consecutive pwCF received ETI. Four dosing steps were defined, at each of which the patients underwent clinical examination, routine blood tests, and therapeutic drug monitoring. Exposure of elexacaftor, tezacaftor, and ivacaftor was assessed by means of determination of AUC. ETI was successfully introduced and maintained in all pwCF. In those with Child-Pugh B cirrhosis (n = 2), diminishment of the dose as recommended by the label resulted in AUC values that were lower than the mean AUC values in pwCF without hepatic impairment, as reported previously. Despite the limitations of this small case series, stepwise elevation of ETI dose did not induce clinical adverse effects or increases in serum liver test results under strict clinical follow-up and therapeutic drug monitoring, and may allow tolerable introduction of this therapy in pwCF and cirrhosis Child-Pugh A and possibly B.

Therapeutic drug monitoring mediated by the cooperative chemical and electromagnetic effects of Ti3C2TX modified with Ag nanocubes

It is pivotal for the credible utilization of surface-enhanced Raman scattering (SERS) technique in clinical drug monitoring to exploit versatile substrates with dependable quantitative detection and robust recognition abilities. Herein, a commendable electromagnetic-chemical dual-enhancement SERS substrate dependent on Ti3C2TX and Ag nanocubes (Ag NCs) was fabricated for the precise quantification of ritonavir and ibrutinib in serum. Specifically, it was revealed that numerous electromagnetic “hotspots” emerged nearby the extremely tiny nanogaps among the intimately clustered Ag NCs, which also acted as optimal channels to facilitate effective photo-induced charge transfer (PICT) between the two-dimensional Ti3C2TX matrix and target molecules. The cooperation between electromagnetic and chemical effects yielded a satisfactory enhancement factor (EF) of 4.77 × 107 for the composite substrate. Benefiting from the remarkable sensitivity of the Ti3C2TX/Ag NCs composite substrate, the low limit of detection (LOD) at 10−6 mg/mL was successfully attained, along with exceptional recoveries of exceeding 90% for ritonavir and ibrutinib in serum. Considering its reliability and simplicity, our strategy holds immense promise for its utilization in efficient monitoring and identification of clinical blood drug concentration.

P301 Step-wise introduction of elexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis and liver cirrhosis Child-Pugh A or B using clinical- and therapeutic drug monitoring: a case series

Serum liver test abnormalities are described as a common adverse effect of elexacaftor-tezacaftor-ivacator (ETI) in patients with Cystic Fibrosis (pwCF). In the phase I registration studies the PK of ETI have been compared between non-CF people with hepatic impairment and healthy individuals. In the former group exposure of ETI was increased and therefore a reduced dose in pwCF and cirrhosis Child-Pugh B is recommended. To our knowledge, there are no data on the exposure of ETI in pwCF and cirrhosis Child-Pugh A or B. In this case series we describe seven pwCF and cirrhosis Child-Pugh A or B where ETI was gradually introduced using clinical and therapeutic drug monitoring (TDM).

Recyclable detection of gefitinib in clinical sample mediated by multifunctional Ag-anchored g-C3N4/MoS2 composite substrate

Surface-enhanced Raman scattering (SERS) technology enables to satisfy the increasing demand of clinical drug monitoring due to the superiority of fingerprint recognition, real-time response, and nondestructive collection. Here, a novel graphitic carbon nitride (g-C3N4)/ molybdenum disulfide (MoS2)/Ag composite substrate with a 3D surface structure was successfully developed for the recyclable detection of gefitinib in serum. Attributed to the uniform and dense “hotspots” on the shrubby active surfaces in conjunction with the potential synergistic chemical enhancement of g-C3N4/MoS2 heterosystem, a remarkable SERS sensitivity with an attractive enhancement factor value of 3.3 × 107 was demonstrated. Meanwhile, a type-II heterojunction between g-C3N4 and MoS2 enabled more efficient diffusion of photogenerated e−-h+ pairs assisted by the localized surface plasmon resonance of Ag NPs, which contributed to the reliable recyclable detection of gefitinib. The ultra-low limit of detection at 10−5 mg/mL and high recycling rates of gefitinib beyond 90% in serum were successfully realized. The results demonstrated the as-prepared SERS substrate has tremendous potential to be untilized for in-situ drug diagnostics.

Risks and benefits of clozapine and lithium co-prescribing: A systematic review and expert recommendations

ObjectivesTo identify the risks and benefits of clozapine‑lithium co-prescription. MethodsArticles published in English or French were identified with a MEDLINE, Web of Sciences and PsycINFO search, from inception through January 2023, using the term ‘clozapine’ in combination with ‘lithium’. Data were synthesized narratively. ResultsOf the 67 articles included in the review, more than half (n = 38, 56.7 %) were focused on clozapine-related blood dyscrasia. A body of evidence drawn from case reports and retrospective chart studies highlights the potential benefits of lithium prescription for clozapine-related neutropenia, since this strategy may avoid clozapine discontinuation or allow its rechallenge. The most documented adverse drug reactions (ADRs) associated with clozapine‑lithium co-prescription are neurotoxic events, which may be prevented or detected early by clinical, electroencephalographic and therapeutic drug monitoring. Causality assessment cannot be established for other reported ADRs occurring during clozapine‑lithium co-prescription. The benefits of the combined prescription on psychotic and/or mood symptoms are poorly documented. ConclusionThe risks and benefits of clozapine‑lithium co-prescription require further exploration as the combination might significantly contribute to reducing underprescription or premature discontinuation of clozapine.

Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine

Biologic drugs have greatly improved treatment outcomes of inflammatory joint diseases, but a substantial proportion of patients either do not respond to treatment or lose response over time. Drug immunogenicity, manifested as the formation of anti-drug antibodies (ADAb), constitute a significant clinical problem. Anti-drug antibodies influence the pharmacokinetics of the drug, are associated with reduced clinical efficacy, and an increased risk of adverse events such as infusion reactions. The prevalence of ADAb differs among drugs and diseases, and the detection of ADAb also depends on the assay format. Most data exist for the tumor necrosis factor-alpha inhibitors infliximab and adalimumab, with a frequency of ADAb that ranges from 10 to 60% across studies. Measurement of ADAb and serum drug concentrations, therapeutic drug monitoring, has been suggested as a strategy to optimize therapy with biologic drugs. Although the recent randomized clinical Norwegian Drug Monitoring (NOR-DRUM) trials show promise towards a personalized medicine prescribing approach by therapeutic drug monitoring, several challenges remain. A plethora of assay formats, with widely differing properties, is currently used for measuring ADAb. Comparing results between different assays and laboratories is difficult, which complicates the development of cut-offs necessary for guidelines and the implementation of ADAb measurements in clinical practice. With the possible exception of infliximab, limited data on clinical relevance and cost effectiveness exist to support therapeutic drug monitoring as a routine clinical strategy to monitor biologic drugs in inflammatory joint diseases. The aim of this review is to provide an overview of the characteristics and prevalence of ADAb, predisposing factors to ADAb formation, commonly used assessment methods, clinical consequences of ADAb, and the potential implications of ADAb assessments for everyday treatment of inflammatory joint diseases.

P133 Post-COVID-19 recurrent fungal urinary tract infections: A case series

Poster session 1, September 21, 2022, 12:30 PM - 1:30 PMBackgroundCOVID-19 has opened a pandora's box of opportunistic infections and immune alteration. We hereby present a series of patients with recurrent fungal urinary tract infections triggered by an episode of COVID-19.DescriptionCase 1: A 66-year-old male, diabetic, known chronic kidney disease, had moderate COVID-19 in September 2020 needing remdesivir and steroids; 2 months later, he was treated for a fungal UTI elsewhere. In May 2021, he presented with right-sided pyelonephritis, hydroureter, and pyonephrosis. DJ stenting was done and cultures grew C. tropicalis. Record of anti-fungal susceptibility from the fluconazole resistance and was hence treated with 21 days of micafungin with significant improvement. Despite 3 weeks of directed anti-fungal treatment, he had recurrent episodes of candiduria with azotemia. Cystoscopy and selective sampling yielded C. tropicalis from the right pelvi-calyceal system, but as he was unwilling for nephrostomy and local antibiotic instillation he was started on anidulafungin and long-term 5-flucytosine suppression.Case 2: A 61-year-old male, diabetic, with uncontrolled sugars, had severe COVID-19 in September 2020 needing oxygen, remdesivir, and steroids; 1 month later, presented with right-sided flank pain and four episodes of painless passage of fleshy tissue per urethra in the last 1 year (Fig. 2). He had multiple episodes of bacterial UTIs which were treated, with complete resolution. The fleshy mass showed septate fungal elements and culture grew Aspergillus flavus sensitive to voriconazole, itraconazole, and posaconazole. He received multiple prolonged courses of voriconazole and caspofungin prior to presenting to us. CT revealed right-sided pyelonephritis with dilated pelvi-calyceal system. The patient was started on 2 weeks of micafungin followed by a prolonged course of voriconazole and 5-flucytosine with close clinical and therapeutic drug monitoring.Case 3: A 68-year-old female, diabetic, had moderate COVID-19 in April 2021, and was given remdesivir and steroids. She was admitted 1 month later with UTI (Pyelonephritis with early forming renal abscess) with urine culture growing CR Klebsiella p. (OXA-48) and C. glabrata for which she was given ceftazidime-A, vibactam, and voriconazole and underwent bilateral DJ stenting followed by stent removal after 1 month along with switching to micafungin in view of repeated candiduria on treatment. She has developed multiple UTIs in the subsequent months with C. auris being isolated twice and bacterial UTIs, treated with antibiotics and micafungin. Subsequent CT revealed retroperitoneal fibrosis encasing the ureters causing obstruction, a biopsy was inconclusive but was empirically started on methotrexate for IgG4 disease.DiscussionThe proposed immune alteration mechanism of COVID-19 of decreased phagocytic function, uncontrolled sugars, and steroid-related neutrophil dysfunction predisposes to several opportunistic infections including fungal infections. It is intriguing that these patients with refractory funguria never underwent any instrumentation The challenges associated with the management of these cases included deranged renal functions precluding the use of intravenous contrast for imaging and several anti-fungal drugs; inadequate urinary penetration of antifungals especially with deranged renal functions and hesitancy with local instillation of antibiotics, and the need for repeated surgical intervention including insertion of stents in an infected urinary tract.

Quantitative Analysis of Exhaled Breath Collected on Filter Substrates via Low-Temperature Plasma Desorption/Ionization Mass Spectrometry.

Breath analysis has attracted increasing attention in recent years due to its great potential for disease diagnostics at early stages and for clinical drug monitoring. There are several recent examples of successful development of real-time, in vivo quantitative analysis of exhaled breath metabolites via mass spectrometry. On the other hand, current mass spectrometer accessibility limitations restrict point-of-care applications. Here now, an offline method is developed for quantitative analysis of exhaled breath collected on inexpensive filter substrates for direct desorption and ionization by using low-temperature plasma-mass spectrometry (LTP-MS). In particular, different operating conditions of the ionization source were systematically studied to optimize desorption/ionization by using glycerol, a low volatility compound. Applications with respect to propofol, γ-valprolactone, and nicotine analysis in exhaled breath are demonstrated in this study. The effects of several filter substrate properties, including filter material and pore size, on the analyte signal were characterized. Cellulose filter papers performed best with the present analytes. In addition, filters with smaller pores enabled a more efficient sample collection. Furthermore, sample-collection flow rate was determined to have a very significant effect, with slower flow rates yielding the best results. It was also found that filters loaded with sample can be successfully stored in glass vials with no observable sample loss even after 3 days. Limits of detection under optimized conditions are shown to be competitive or significantly better compared with relevant techniques and with additional benefits of cost-efficiency and sample storage capabilities.

Abstract 13: High-Throughput, Non-Invasive Raman Spectroscopy of Anticancer Nanomedicine for Liver Cancer Therapeutic Intervention

Abstract Purpose: Liver cancer remains one of the most difficult to treat, heterogeneous forms of cancer with poor prognosis. Available current therapies face many limitations. Raman spectroscopy is a promising platform for clinical drug development and surgical interventions for improved patient outcomes. Herein, we present a new insight with a rapid, non-destructive, non-invasive Raman spectroscopy modality based molecular signatures unique to anticancer nanomedicine signifying distinct stratification in liver cancer treated tissues of SCID mice. Methods: The therapeutic intervention was investigated using a high-throughput Raman spectroscopy in ex vivo liver tissues treated with combinatorials; targeted and non-targeted polymeric nanocomplexes encapsulated microtubule inhibitors against metastatic liver cancer in SCID mice. Principal Component Analysis (PCA), Linear Discriminate Analysis (LDA) for multivariate data analysis, and cross validation method was used to extrapolate the high throughput Raman based treatment efficiency study in ex vivo liver tissues. Results: Raman spectral signatures obtained by Raman spectroscopy of liver tissue samples of healthy normal liver versus liver cancer cohorts exhibited complete discrimination of healthy ones from the affected diseased counterparts with high accuracy classification. This could be useful as a liver cancer diagnosis tool. Peculiar Raman profiles with distinct stratification of targeted anticancer nanomedicine combinatorials treated cohort were observed. Interestingly, apoptotic lipid bodies and amide I was the prominent features revealed in anticancer nanomedicine combinatorials treatment cohorts. Conclusion: Our approach is a significant advancement for unique Raman molecular signatures-based targeted anticancer nanomedicine combinatorials therapeutic intervention for liver cancer in tissues. Clinical translation of this proposed modality would define Raman based rapid, high-throughput platform for the clinical drug development and monitoring against liver cancer remains warranted. Citation Format: Radhika Poojari, Mithila Bhujbal, Arti Hole, Murali Krishna Chilakapati. High-Throughput, Non-Invasive Raman Spectroscopy of Anticancer Nanomedicine for Liver Cancer Therapeutic Intervention [abstract]. In: Proceedings of the 9th Annual Symposium on Global Cancer Research; Global Cancer Research and Control: Looking Back and Charting a Path Forward; 2021 Mar 10-11. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2021;30(7 Suppl):Abstract nr 13.

Rapid determination of folic acid and riboflavin in urine by polypyrrole magnetic solid-phase extractant combined ultra-performance liquid chromatography

Determination of folic acid and riboflavin in biological samples is difficult due to their high polarity, low concentration, chemical instability, and complex matrix. In this study, the polypyrrole-coated magnetic nanocomposite (Fe3O4@PPy) was synthesized innovatively with the assistance of hexadecyltrimethylammonium bromide. To evaluate the adsorption mechanism and the feasibility of synthesized Fe3O4@PPy as an adsorbent, the adsorption capacities, kinetics and thermodynamics of folic acid and riboflavin were investigated systemically. Furthermore, in light of the chemical instability of folic acid and riboflavin a method for rapid extraction and detection of them from human urine within 10 min was developed successfully by combining magnetic solid phase extraction with ultra-performance liquid chromatography (MSPE/UPLC). The adsorption parameters including sorbent amount, pH value, extraction time, desorption solvent and desorption time were studied. Under optimum conditions, the performance of the established determination method was validated with the linearly dependent coefficients (>0.9995), the limits of detection (0.02–0.05 µg/mL), the limits of quantification (0.07–0.18 µg/mL), and the recoveries (92.2–105.1%, with relative standard deviation < 3.3%). The rapid extraction and detection of folic acid and riboflavin from real urine samples were achieved subsequently. The present study suggests that the developed method exhibits a promising application in the analysis of free folic acid and riboflavin in human urine samples, which can provide a reference for the clinical drug monitoring and treatment.

Three efficient chemometrics assisted fluorimetric detection methods for interference-free, rapid, and simultaneous determination of ibrutinib and pralatrexate in various complicated biological fluids

In this study, a series of green, interference-free fluorimetric detection methods of the excitation-emission matrix coupled with the second-order calibration methods were proposed for the determination of ibrutinib and pralatrexate in various complicated biological fluids. The second-order advantage of the proposed method can overcome the problem of poor selectivity caused by the wide spectra of the fluorescence method. Even in the presence of uncalibrated interferences and severe peak overlap, the signal of pure substance and accurate quantitative results were still obtained. The average recoveries of the three methods were 94.5–104.9% for Alternating Trilinear Decomposition (ATLD) algorithm, 95.5–105.8% for Alternating Normalization Weighted Error (ANWE) algorithm and 94.4–105.7% for Parallel Factor Analysis (PARAFAC) algorithm, respectively. For ATLD, ANWE and PARAFAC, the relative standard deviations (RSD) were lower than 9.2%, 6.8% and 9.2%, and the RMSEPs were less than 8.1, 8.4 and 8.6 ng mL−1, respectively. In addition, the elliptic joint confidence region (EJCR) was adopted to further prove the accuracy of the three methods. The results showed that the three methods can accurately be quantified without significant difference. Good figures of merit parameters were also obtained. Among them, the limit of detection (LOD) and limit of quantification (LOQ) of ibrutinib and pralatrexate were in the range of 0.11–0.76 ng mL−1 and 0.21–1.12 ng mL−1, respectively, which were lower than the corresponding blood concentrations. These results indicate that the proposed method provides a promising, alternative and universal analysis strategy for clinical drug monitoring.

Clinical Applications of Visual Plasmonic Colorimetric Sensing.

Colorimetric analysis has become of great importance in recent years to improve the operationalization of plasmonic-based biosensors. The unique properties of nanomaterials have enabled the development of a variety of plasmonics applications on the basis of the colorimetric sensing provided by metal nanoparticles. In particular, the extinction of localized surface plasmon resonance (LSPR) in the visible range has permitted the exploitation of LSPR colorimetric-based biosensors as powerful tools for clinical diagnostics and drug monitoring. This review summarizes recent progress in the biochemical monitoring of clinical biomarkers by ultrasensitive plasmonic colorimetric strategies according to the distance- or the morphology/size-dependent sensing modes. The potential of colorimetric nanosensors as point of care devices from the perspective of naked-eye detection is comprehensively discussed for a broad range of analytes including pharmaceuticals, proteins, carbohydrates, nucleic acids, bacteria, and viruses such as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The practical suitability of plasmonic-based colorimetric assays for the rapid visual readout in biological samples, considering current challenges and future perspectives, is also reviewed.

Renal Transplantation in Mansoura, Egypt.

Renal Transplantation in Mansoura, Egypt.

Real-time breath analysis of exhaled compounds upon peppermint oil ingestion by secondary electrospray ionization-high resolution mass spectrometry: technical aspects

Breath analysis by secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) has potential for clinical diagnosis and drug monitoring. However, there is still a lack of benchmarking data that shows the capability of this technique and allows comparability with other breath analysis techniques. In this regard, the goal of this study was the identification of volatile compounds upon ingestion of a specific peppermint oil capsule to get benchmark data for real-time breath analysis with SESI-HRMS. This was done in the framework of a consortium set up by the International Association of Breath Research (IABR), aimed at comparing several analytical instruments for breath analysis.Breath temporal profiles of two subjects were analyzed with SESI-HRMS before and after ingestion of a peppermint oil capsule. The measurements were performed at two different locations using identical SESI-HRMS platforms to allow for comparability and benchmarking. Remarkably, along with the four major compounds (monoterpenes/cineole, menthone, menthofuran and menthol) reported by other members of the consortium, we detected 57 additional features significantly associated (ρ > 0.8) with the peppermint oil capsule, suggesting that this relatively simple intervention might trigger a more complex metabolic cascade than initially expected. This observation was made on both sites. Additional replicate experiments for one of the subjects suggested that a core of 35–40 unique molecules are consistently detected in exhaled breath upon ingestion of the capsule. In addition, we illustrate the analytical capabilities of real-time SESI-HRMS/MS to assist in the identification of unknown compounds. The results outlined herein showcase the performance of SESI-HRMS and enable comparison with other breath analysis techniques. Along with that, they strengthen the potential of this analytical technique for non-invasive drug monitoring and clinical diagnostic purposes.

Privileges of Pharmacist in Saudi Arabia: Administration and Management

PTB Reports,2020,6,1,7-12.DOI:10.5530/PTB.2020.6.2Published:March 2020Type:Research ArticleAuthors:Faisal Al-Otaibi, Mohamed Soliman Imam, Randa Mansour Abdel-Sattar Ahmed, Amsha Alotaibi, Asma Alotaibi, Amal Alotaibi, Wesam Alsuwaid, and Yousef Ahmed Alomi Author(s) affiliations:Faisal Al-Otaibi, Ph. D, Assistant Professor, College of Pharmacy, Pharmacy Patrice Department, Shaqra University, Saudi Arabia. Mohamed Soliman Imam, Ph. D, Assistant Professor, Dean, College of Pharmacy, Shaqra University, Saudi Arabia. Randa Mansour Abdel-Sattar Ahmed, Ph.D, Biomedical Science Department, College of Pharmacy, Shaqra University, Saudi Arabia. Amsha Alotaibi, Pharm D, Clinical Pharmacist, College of Pharmacy, Pharmacy Patrice Department, Shaqra University, Riyadh, Saudi Arabia. Asma Alotaibi, Pharm D, Clinical Pharmacist, College of Pharmacy, Pharmacy Practice Department, Shaqra University, Saudi Arabia. Amal Alotaibi, Pharm D, Clinical Pharmacist, College of Pharmacy, Shaqra University, Saudi Arabia. Wesam Alsuwaid, Pharm D, Clinical Pharmacist, College of Pharmacy, Pharmacy Practice Department, Shaqra University, Saudi Arabia. Yousef Ahmed Alomi*, BSc. Pharm, MSc. Clin Pharm, BCPS, BCNSP, DiBA, CDE, Critical Care Clinical Pharmacists, TPN Clinical Pharmacist, Freelancer Business Planner, Content Editor and Data Analyst, P.O.BOX 100, Riyadh, Saudi Arabia. Abstract:Objectives: To explore the privileges of pharmacists through the pharmacy administration and management in Saudi Arabia. Methods: This is a 4-month cross-sectional survey regarding the privileges of pharmacists in Saudi Arabia. The study consisted of two parts: the first part collected demographic information and the second part comprised a questionnaire with 28 questions divided into 4 domains. The questions were derived from previous literature and from the regulatory standards of the American Society of Health-System Pharmacists (ASHP). The four domains were as follows: privilege management and resources, pharmacist prescribing and therapeutic interchange, clinical and administration privilege and drug monitoring and healthcare education. The responses were obtained using a 5-point Likert response scale system with close- and open-ended questions. The survey questionnaire was distributed in an electronic format to the hospital’s director of pharmacy of each hospital in Saudi Arabia. In this study, we analyzed pharmacist’s privilege in Saudi Arabia with regard to the pharmacy administration and management. All data were obtained through the Survey Monkey system. Results: The survey was distributed to 36 hospitals. The administration-related elements of pharmacist privilege with maximum score were policies and procedures of pharmacist’s privilege (3.88 (77.6%)) followed by the vision of pharmacist privilege (3.57 (71.4%)) and pharmacist privilege in the job description (3.56 (71.2%)). The average score of pharmacist privilege in the hospital committees was 3.47 (69.40%). Most of the committees having pharmacist privilege was the patient or medication safety committee (4.09 (81.8%)) followed by the pharmacy and therapeutic committee (4.06 (81.2%)) and quality management committee (4.06 (81.2%)). The average score of pharmacist privilege in the teams was 3.44 (68.85%). The majority of the teams having pharmacist privilege was antibiotics team (4.25 (85%)) followed by anticoagulation team (3.86 (77.2%)) and IV therapy team (3.81 (76.2%)). Conclusion: The privileges of a pharmacists is inadequate in the Kingdom of Saudi Arabia. Future programs should target to improve the healthcare system and expand pharmacists’ role in the hospital practice. This might improve the pharmaceutical care services and patient outcomes and prevent drug-related problems and unnecessary economic expenditure on the healthcare practice in Saudi Arabia. Keywords:Administration, Management, Pharmacist, Privileges, Saudi ArabiaView:PDF (213.19 KB) PDF PDF Images Responders’ experiences of pharmacy practice

Beyond Survival in Solid Organ Transplantation: A Summary of Expert Presentations from the Sandoz 6th Standalone Transplantation Meeting, 2018.

Beyond Survival in Solid Organ Transplantation: A Summary of Expert Presentations from the Sandoz 6th Standalone Transplantation Meeting, 2018.