Journal of Applied Bioanalysis最新文献

Box-Behnken Design (BBD) Based Optimization of Mucoadhesive Tablet Loaded Nifedipine: In-vitro Release and Stability Studies 基于盒-贝肯设计（BBD）的硝苯地平粘合片剂优化：体外释放和稳定性研究

Journal of Applied Bioanalysis Pub Date : 2024-06-13 DOI: 10.53555/v10.001

Anuj Pathak, Satish Kumar Sharma

引用次数: 0

Challenges in Development and Qualification of PCR/dPCR Assays for Gene Therapy Biodistribution and Viral Shedding Assessment 基因治疗生物分布和病毒脱落评估中PCR/dPCR方法发展和鉴定的挑战

Journal of Applied Bioanalysis Pub Date : 2023-08-27 DOI: 10.17145/jab.23.003

K. Pineault, B. Danis, Sabrina Lory, Daisy Yuill

{"title":"Challenges in Development and Qualification of PCR/dPCR Assays for Gene Therapy Biodistribution and Viral Shedding Assessment","authors":"K. Pineault, B. Danis, Sabrina Lory, Daisy Yuill","doi":"10.17145/jab.23.003","DOIUrl":"https://doi.org/10.17145/jab.23.003","url":null,"abstract":"Gene therapies are part of a larger class of advanced therapies that aim to treat disease via delivery of recombinant genetic material. A gene therapy product has two components, the delivery system (viral vector or non-viral) and the transgene (DNA or RNA). These therapies act via replacement of a non-functional gene, silencing of a disease-causing gene, or introduction of a new or modified gene with the goal of generating a therapeutic response in patients. Gene therapy biodistribution and viral vector shedding must be evaluated during non-clinical testing. Polymerase chain reaction (PCR) has emerged as the technique of choice to quantify the gene therapy product and the transferred genetic material in study samples. With increasing numbers of gene therapies in pre-clinical development, there has been a concomitant increase in the use of PCR in bioanalytical laboratories. A major challenge in this space is the lack of formal guidance for the development, characterization, and validation of PCR assays. This article will focus on the opportunities and challenges in developing and characterizing non-GLP, digital PCR assays for AAV gene therapy products. AAV vectors are currently the most common viral delivery system, however many of the insights presented will be applicable to other delivery systems.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79916607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Current Challenges and Opportunities in using the LAL Assay for Endotoxin Testing 当前使用LAL法检测内毒素的挑战和机遇

Journal of Applied Bioanalysis Pub Date : 2023-04-04 DOI: 10.17145/jab.23.002

Timothy J. Francis

引用次数: 0

Pharmacokinetic Profile of Metformin and SGLT2 Inhibitors alone and in Combination: a Pharmacokinetic Study in Wistar Rats 二甲双胍和SGLT2抑制剂单独和联合的药代动力学特征:Wistar大鼠的药代动力学研究

Journal of Applied Bioanalysis Pub Date : 2023-02-10 DOI: 10.17145/jab.23.001

M. Millan Fachi, Bruna Carolina Lui Dias, Jonata Augusto de Oliveria, Rosângela Gonçalves Peccinini, R. Pontarolo, M. D. de Campos

{"title":"Pharmacokinetic Profile of Metformin and SGLT2 Inhibitors alone and in Combination: a Pharmacokinetic Study in Wistar Rats","authors":"M. Millan Fachi, Bruna Carolina Lui Dias, Jonata Augusto de Oliveria, Rosângela Gonçalves Peccinini, R. Pontarolo, M. D. de Campos","doi":"10.17145/jab.23.001","DOIUrl":"https://doi.org/10.17145/jab.23.001","url":null,"abstract":"Objective: To achieve glycemic control, a combination of drugs is eventually necessary, especially the dual therapy of SGLT2 inhibitors with metformin. Despite the value of combination therapy, understanding the pharmacokinetic properties is critical. Therefore, this study aimed to conduct the combined and isolated administration of hypoglycemic drugs to understand their pharmacokinetic properties. Methodology: The study was performed by gavage in twenty-five rats that were divided into five groups: metformin alone (60 mg/kg), canagliflozin alone 20 mg/kg, canagliflozin and metformin (20 mg/kg and 60 mg/kg, respectively), dapagliflozin alone 2 mg/kg, and dapagliflozin and metformin (2 mg/kg and 60 mg/kg, respectively). Blood samples were collected between 0.25 and 36 hours postdose and quantified by an HPLC-MS/MS method. Results: The metformin pharmacokinetics showed values lower than those from literature, but the most relevant result was a significant change in Cmax (3400 ng/mL), AUC (872.4 ng.min/L) and CL/F (72 mL/min/kg) in the metformin with dapagliflozin group compared to metformin alone Cmax (523 ng/mL), AUC (106.8 ng.min/L) and CL/F (752 mL/min/kg). For canagliflozin, the Cmax of 6116.7 ng/mL observed in our study was similar to that observed in literature, while the clearance (5.1 mL/min/kg) was higher than that of literature, which was 3.5 mL/min/kg. Clearance of dapagliflozin CL/F was reported as 3.33 mL/min/kg, while our result was 4.6 mL/min/kg. The same study also published dapagliflozin half-life and MRT, which were slightly lower than our findings. In general, the parameters of canagliflozin and dapagliflozin were similar to the literature and did not change with simultaneous administration with metformin. Conclusion: Dapagliflozin significantly changed the pharmacokinetic disposition of metformin, while metformin coadministration had no influence on the pharmacokinetics of SGLT2 inhibitors","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90977458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Survey on Microsampling in Bioanalysis: Opportunities and Challenges-Results and Conclusions 生物分析中的微采样研究:机遇与挑战-结果与结论

Journal of Applied Bioanalysis Pub Date : 2022-12-23 DOI: 10.17145/jab.22.002

R. Meesters

引用次数: 0

Fit-for-Purpose Validation of a PK Assay applying Blood Collection by Volumetric Absorptive Microsampling 体积吸收显微采血法PK测定的适用性验证

Journal of Applied Bioanalysis Pub Date : 2022-11-20 DOI: 10.17145/jab.22.001

J. R. Rincon Pabon, R. Meesters

{"title":"Fit-for-Purpose Validation of a PK Assay applying Blood Collection by Volumetric Absorptive Microsampling","authors":"J. R. Rincon Pabon, R. Meesters","doi":"10.17145/jab.22.001","DOIUrl":"https://doi.org/10.17145/jab.22.001","url":null,"abstract":"OBJECTIVES: Validation and application of a fit-for-purpose PK assay used for quantitative analysis of acetaminophen in whole blood applying volumetric absorptive microsampling using MITRA® devices. METHODS: MITRA® devices were evaluated using whole blood samples prepared at different hematocrit values. PK assay parameters precision, accuracy, linearity, LOD, LLOQ, ULOQ, carry-over, and stability of analyte in dried whole blood on MITRA® device were validated following EMA guidelines. Acetaminophen was quantified by LC-HRMS. MITRA® devices were used on selected timepoints post-dose to collect capillary blood after finger prick. Acetaminophen was extracted using methanol containing acetaminophen-d4. RESULTS: Adsorbed whole blood volume ranged from 9.79 ± 0.18, 9.95 ± 0.34, and 10.10 ± 0.48 µL for 20, 45 and 65 % hematocrit. Highest intra-day precision and accuracy were 11.4 % CV and -19.7 %bias at 1 µg/ml. Highest inter-day precision and accuracy were 12.3% CV and -18.8 %bias at 1 µg/mL. Measuring range was 1-25 µg/mL and LOD of 0.30 µg/mL. ACP was stable on Mitra® device tip for up to 4 weeks. Obtained results from the pharmacokinetic study were not significantly different to parameters reported in the literature using plasma samples. CONCLUSIONS: MITRA® devices have a great potential use as an alternative whole blood collection device in comparison with other blood sampling techniques or devices.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86390410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A simple HPLC-UV Method for Therapeutic Drug Monitoring of Linezolid in human Plasma in low-resourced settings 资源匮乏地区人血浆中利奈唑胺治疗药物监测的高效液相色谱-紫外分光光度法

Journal of Applied Bioanalysis Pub Date : 2021-12-15 DOI: 10.17145/jab.21.008

V. A, S. V, Alffenaar Jw, Jeyakumar Sm, H. Ak

引用次数: 2

Utility of LC-MS Surrogate Peptide Methodology in the Development of a Combinectin, a Unique Anti-HIV Biologic Drug LC-MS替代肽方法学在一种独特的抗hiv生物药物组合蛋白开发中的应用

Journal of Applied Bioanalysis Pub Date : 2021-07-10 DOI: 10.17145/JAB.21.007

Yulia Benitex, Jonathan H. Davis, David L. Wensel, Tracy S. Mitchell, M. Krystal, D. Drexler

引用次数: 0

Perspectives on Business and Bioanalysis: An interview with Dr. Shane Needham 商业和生物分析的观点:采访Shane Needham博士

Journal of Applied Bioanalysis Pub Date : 2021-06-01 DOI: 10.17145/JAB.21.006

S. Needham