must be appropriately measured throughout the whole clinical development journey. The development strategy of a biological assay that is able to measure potency accurately and precisely needs to be based on both regulatory and business requirements. Regulatory expectations on potency tests are detailed in international guidelines and constitute a legal requirement for the registration of the drug in the region of submission. However, the development and implementation of biological assays are known to be expensive and time-consuming. This fact opens a debate on how to balance the companies’ business needs with the requests for Mode of Action (MoA)-mimicking cell-based assays to determine the potency of increasingly complex biopharmaceuticals. This article overviews the current regulatory requirements for the registration of new biological drugs in USA, Europe and Japan giving a focused perspective on bioassay development strategies.
{"title":"Regulatory Perspective on Bioassay Implementation Strategies for Potency Evaluation of Biopharmaceuticals","authors":"A. Pepe","doi":"10.17145/JAB.21.002","DOIUrl":"https://doi.org/10.17145/JAB.21.002","url":null,"abstract":"must be appropriately measured throughout the whole clinical development journey. The development strategy of a biological assay that is able to measure potency accurately and precisely needs to be based on both regulatory and business requirements. Regulatory expectations on potency tests are detailed in international guidelines and constitute a legal requirement for the registration of the drug in the region of submission. However, the development and implementation of biological assays are known to be expensive and time-consuming. This fact opens a debate on how to balance the companies’ business needs with the requests for Mode of Action (MoA)-mimicking cell-based assays to determine the potency of increasingly complex biopharmaceuticals. This article overviews the current regulatory requirements for the registration of new biological drugs in USA, Europe and Japan giving a focused perspective on bioassay development strategies.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89314088","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}
{"title":"Welcome to the seventh Volume of Journal of Applied Bioanalysis","authors":"R. Meesters","doi":"10.17145/jab.21.001","DOIUrl":"https://doi.org/10.17145/jab.21.001","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82800092","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}
{"title":"Perspectives on Multi-Omics and Omics Applications in Biomedical Research: an Interview with Dr. Biswapriya B. Misra","authors":"B. Misra","doi":"10.17145/jab.20.011","DOIUrl":"https://doi.org/10.17145/jab.20.011","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77504533","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}
Yifan Shi, H. Murrey, Kay Ahn, Naidong Weng, Shefali R Patel
{"title":"LC-MS/MS assay for the simultaneous quantitation of thromboxane B2 and prostaglandin E2 to evaluate cyclooxygenase inhibition in human whole blood","authors":"Yifan Shi, H. Murrey, Kay Ahn, Naidong Weng, Shefali R Patel","doi":"10.17145/jab.20.014","DOIUrl":"https://doi.org/10.17145/jab.20.014","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78964677","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}
Multi-omics is a rising filed in omics science. Despite progress in the development of an appropriate single omics, in-particular for biomedical problem solving; the holistic look at the complex nature of the human cell, disease, and other biochemical pathways remain undiscovered. The multi-omics platform considered the most integrated system currently available to obtain and measure the biochemical data-driven information for biomedical problems. The current review will look at the factors that play important roles in the rise of the multiomics fields and its application in biomedical studies.
{"title":"Multi-omics for Biomedical Applications","authors":"M. S. Khan, J. Azmir","doi":"10.17145/jab.20..012","DOIUrl":"https://doi.org/10.17145/jab.20..012","url":null,"abstract":"Multi-omics is a rising filed in omics science. Despite progress in the development of an appropriate single omics, in-particular for biomedical problem solving; the holistic look at the complex nature of the human cell, disease, and other biochemical pathways remain undiscovered. The multi-omics platform considered the most integrated system currently available to obtain and measure the biochemical data-driven information for biomedical problems. The current review will look at the factors that play important roles in the rise of the multiomics fields and its application in biomedical studies.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86825609","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}
Morse Faria, O. Ismaiel, James Waltrip, Thomas Mariannino, Moucun Yuan, W. Mylott, V. Roongta, Jim X. Shen, Pathanjali Kadiya
RESULTS: A sensitive method was developed and validated for the measurement of tanespimycin and its active 17-AG in human plasma using tanespimycin -C3, 15N as an internal standard. The assay was validated over the concentration range of 10.0 to 2500 ng/mL for tanespimycin and 5.00 to 1250 ng/mL for 17-AG. During method development, an internal standard variability due to an in-source reduction of the quinone moiety during ionization was observed. The in-source reduction was mitigated by selection of appropriate mobile phases, internal standard concentration, injection volume, source temperature, and continuous maintenance of the source between runs.
{"title":"LC-MS/MS Method for the Quantitative Determination of Tanespimycin and its Active Metabolite in Human Plasma: Method Validation and Overcoming an Insidious APCI Source Phenomenon","authors":"Morse Faria, O. Ismaiel, James Waltrip, Thomas Mariannino, Moucun Yuan, W. Mylott, V. Roongta, Jim X. Shen, Pathanjali Kadiya","doi":"10.17145/jab.20.015","DOIUrl":"https://doi.org/10.17145/jab.20.015","url":null,"abstract":"RESULTS: A sensitive method was developed and validated for the measurement of tanespimycin and its active 17-AG in human plasma using tanespimycin -C3, 15N as an internal standard. The assay was validated over the concentration range of 10.0 to 2500 ng/mL for tanespimycin and 5.00 to 1250 ng/mL for 17-AG. During method development, an internal standard variability due to an in-source reduction of the quinone moiety during ionization was observed. The in-source reduction was mitigated by selection of appropriate mobile phases, internal standard concentration, injection volume, source temperature, and continuous maintenance of the source between runs.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87663402","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}
Along with improved knowledge of cancer biology and biotechnical progress, the diagnostic approaches have evolved from tissue biopsies to liquid biopsies. As they provide a minimally invasive tumor detection, liquid biopsies allow early diagnosis and serial assessments of tumor progression. Discovery and use of circulating tumor markers circulating tumor DNA (ctDNA), circulating tumor cells (CTC), and exosomes have largely expanded the possibility of early diagnosis of cancer, patient stratification, as well as developing a personalized treatment. Based on these circulomes, liquid biopsies can be developed, but each type of liquid biopsies has its own merits and limitations. While ctDNA-based methods represent the most advanced techniques, sensitivity improvement is expected given the rarity of ctDNA in circulation. As intact cancer cells, CTC provide information on cancer cells. However, current CTC capturing procedures are still lack of efficiency. Exosomes are abundant, but they are highly heterogeneous and there is a lack of specific markers for identification. Future efforts are needed to improve operational parameters and clinical performance of each method. Prior to a broad use in clinical settings, it is crucial to standardize the procedure for the specific liquid biopsy method and validate the test with adequate specificity and sensitivity for clinical applications.
{"title":"Clinical Applications of Circulating Tumor DNA, Circulating Tumor Cells, and Exosomes as Liquid Biopsy-Based Tumor Biomarkers","authors":"Xiaoshuang Yan, Chao-Chi Yeh, Linglong Zou","doi":"10.17145/jab.20.013","DOIUrl":"https://doi.org/10.17145/jab.20.013","url":null,"abstract":"Along with improved knowledge of cancer biology and biotechnical progress, the diagnostic approaches have evolved from tissue biopsies to liquid biopsies. As they provide a minimally invasive tumor detection, liquid biopsies allow early diagnosis and serial assessments of tumor progression. Discovery and use of circulating tumor markers circulating tumor DNA (ctDNA), circulating tumor cells (CTC), and exosomes have largely expanded the possibility of early diagnosis of cancer, patient stratification, as well as developing a personalized treatment. Based on these circulomes, liquid biopsies can be developed, but each type of liquid biopsies has its own merits and limitations. While ctDNA-based methods represent the most advanced techniques, sensitivity improvement is expected given the rarity of ctDNA in circulation. As intact cancer cells, CTC provide information on cancer cells. However, current CTC capturing procedures are still lack of efficiency. Exosomes are abundant, but they are highly heterogeneous and there is a lack of specific markers for identification. Future efforts are needed to improve operational parameters and clinical performance of each method. Prior to a broad use in clinical settings, it is crucial to standardize the procedure for the specific liquid biopsy method and validate the test with adequate specificity and sensitivity for clinical applications.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86783902","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}
S. Ghimire, Erwin M. Jongedijk, Simone H J van den Elsen, Mireille A. Wessels, D. Touw, J. Alffenaar
Financial & Competing interests: The authors have declared that no competing interest exist. 1University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy and Pharmacology, Groningen, The Netherlands; 2University of Groningen, Groningen Research Institute of Pharmacy, Department of Pharmacokinetics Toxicology and Targeting, Groningen, The Netherlands; 3University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, Australia; 4Westmead hospital, Sydney, Australia.
{"title":"Cross-validation of Liquid Chromatography-Tandem Mass Spectrometry Method for Quantification of Levofloxacin in Saliva","authors":"S. Ghimire, Erwin M. Jongedijk, Simone H J van den Elsen, Mireille A. Wessels, D. Touw, J. Alffenaar","doi":"10.17145/jab.20.008","DOIUrl":"https://doi.org/10.17145/jab.20.008","url":null,"abstract":"Financial & Competing interests: The authors have declared that no competing interest exist. 1University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy and Pharmacology, Groningen, The Netherlands; 2University of Groningen, Groningen Research Institute of Pharmacy, Department of Pharmacokinetics Toxicology and Targeting, Groningen, The Netherlands; 3University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, Australia; 4Westmead hospital, Sydney, Australia.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84912423","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}
Novel materials used in preventive and restorative dentistry contain monomers with endocrine or cytotoxic properties, which can cause minimum or even severe damage to human body, when found in specific concentrations. The degradation of resin composite restorations after aging and/or storage in different solutions is associated with leaching monomers, like bisphenol Aglycidyl methacrylate (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), Urethane dimethacrylate (UDMA), Bisphenol A (BPA), which are potentially leading to toxicity and mutagenicity effects or cause allergic reactions. These monomers may cause health issues to patients, therefore their determination both in-vitro and in biological fluids e.g. saliva, blood serum/plasma and urine is significant. Moreover, analytical methods are necessary to investigate the rate of elution, as well as the conditions that mainly affect the mechanism of short-term and long-term release of monomers from dental composites. In this review article we present some of the techniques and methods used to determine the short-term and long-term release of these monomers from modern dental materials and prove that analytical chemistry and especially bioanalysis can be a powerful tool in dentistry
{"title":"Bioanalysis as a powerful tool in Dentistry: the case of short-term and long-term release of Monomers from dental Composites","authors":"E. Diamantopoulou, V. Samanidou","doi":"10.17145/jab.20.010","DOIUrl":"https://doi.org/10.17145/jab.20.010","url":null,"abstract":"Novel materials used in preventive and restorative dentistry contain monomers with endocrine or cytotoxic properties, which can cause minimum or even severe damage to human body, when found in specific concentrations. The degradation of resin composite restorations after aging and/or storage in different solutions is associated with leaching monomers, like bisphenol Aglycidyl methacrylate (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), Urethane dimethacrylate (UDMA), Bisphenol A (BPA), which are potentially leading to toxicity and mutagenicity effects or cause allergic reactions. These monomers may cause health issues to patients, therefore their determination both in-vitro and in biological fluids e.g. saliva, blood serum/plasma and urine is significant. Moreover, analytical methods are necessary to investigate the rate of elution, as well as the conditions that mainly affect the mechanism of short-term and long-term release of monomers from dental composites. In this review article we present some of the techniques and methods used to determine the short-term and long-term release of these monomers from modern dental materials and prove that analytical chemistry and especially bioanalysis can be a powerful tool in dentistry","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83464496","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}
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