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Journal articles on the topic 'Bioanalytical study'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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1

Makowski, Nina, Agnes M. Ciplea, Mohsin Ali, Ilja Burdman, Anke Bartel, and Bjoern B. Burckhardt. "A comprehensive quality control system suitable for academic research: application in a pediatric study." Bioanalysis 12, no. 5 (2020): 319–33. http://dx.doi.org/10.4155/bio-2019-0242.

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Aim: Clinical research in pediatrics is progressively initiated by academia. As the reliability of pharmacodynamic measures is closely linked to the quality of bioanalytical data, bioanalytical quality assurance is crucial. However, clear guidance on comprehensive bioanalytical quality monitoring in the academic environment is lacking. Methods & results: By applying regulatory guidelines, international recommendations and scientific discussions, a five-step quality control system for monitoring the bioanalysis of aldosterone by immunoassay was developed. It comprised performance qualificat

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2

Singh, Anamika, and Tamanna Narsinghan. "BIOANALYTICAL METHOD VALIDATION: A COMPREHENSIVE ASSESSMENT OF VARIOUS REGULATORY GUIDELINES." Indian Drugs 60, no. 06 (2023): 7–25. http://dx.doi.org/10.53879/id.60.06.12583.

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Bioanalytical methods are used to analyse an analyte in a biological matrix. Bioanalytical method validation is the process of determining the suitability of the given bioanalytical methodology for providing the required analytical data. Validation of the bioanalytical methods demonstrates and ensures that the methods used for the quantification of analyte in biological fluids are reliable, reproducible and suitable for its intended application. Different regulatory agencies like Food and Drug administration (FDA), The National Health Surveillance Agency or Agência Nacional de Vigilância Sanit

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3

Sun, Yuchen, Shin-ichiro Nitta, Kosuke Saito, et al. "Development and multicenter validation of an LC–MS-based bioanalytical method for antisense therapeutics." Bioanalysis 14, no. 18 (2022): 1213–27. http://dx.doi.org/10.4155/bio-2022-0126.

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Background: Many bioanalytical methods for antisense oligonucleotides (ASOs) using LC–MS have been reported. However, no data have been available on the reproducibility and robustness of a single bioanalytical method for ASOs. As such, in the current study, we evaluated the reproducibility and robustness of LC–MS-based bioanalytical methods for ASOs in multiple laboratories. Methods/Results: Seven independent laboratories were included in this study. Mipomersen was measured by ion-pairing LC–MS (IP-LC–MS) as a model ASO using different LC–MS. The validation results of calibration curve, accura

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Mrinalini, C. Damle* and Sanchita A. Kale. "DETERMINATION OF ETRAVIRINE IN HUMAN PLASMA BY HPLC." Indo American Journal of Pharmaceutical Sciences 04, no. 06 (2017): 1657–64. https://doi.org/10.5281/zenodo.821178.

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A simple bioanalytical HPLC method for the estimation of Etravirine in human plasma has been developed and validated. Fenofibrate was used as an Internal Standard . Extracted sample was eluted using C18 (250 x 4.6 mm, 5 μm) column. The mobile phase consisted of Acetonitrile:Water in the ratio of 85:15 v/v which was sonicated to degas and delivered at a flow rate of 1 ml/min at ambient temperature. The retention time of Etravirine and Fenofibrate was 5.32(± 0.1) and 3.58(± 0.1) minutes respectively. Studies were performed using an HPLC system equipped with a UV detector; the response was monito

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Casero, E., A. Martinez G. de Quesada, J. Jin, et al. "Comprehensive Study of Bioanalytical Platforms: Xanthine Oxidase." Analytical Chemistry 78, no. 2 (2006): 530–37. http://dx.doi.org/10.1021/ac051676l.

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Flores-Cruz, Ricardo, Rafael López-Arteaga, Lizbeth Ramírez-Vidal, Fernando López-Casillas, and Arturo Jiménez-Sánchez. "Unravelling the modus-operandi of chromenylium-cyanine fluorescent probes: a case study." Physical Chemistry Chemical Physics 21, no. 28 (2019): 15779–86. http://dx.doi.org/10.1039/c9cp03256h.

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Neha, Gaikwad* Kanchan Shinde Varsha Pangale Charushila Bhangale. "Bioanalytical Method Development And Validation For The Estimation Of Active Pharmaceuticals In Dosage Forms." Int. J. in Pharm. Sci. 1, no. 2 (2023): 143–52. https://doi.org/10.5281/zenodo.7755584.

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In this review article, bioanalytical techniques are often employed to quantify pharmaceuticals and their metabolites in plasma matrices, and the techniques should be used in both human clinical investigations and nonhuman research. A key component of estimate and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic investigations is the use of the bioanalytical technique for the quantitative measurement of medicines and their metabolites in biological medium. Method creation, method validation, and sample analysis are the three main responsibilities of bioanalysis. To determin

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Kellie, John F., Yun W. Alelyunas, Josh Albert, et al. "Intact mAb LC–MS for drug concentration from pre-clinical studies: bioanalytical method performance and in-life samples." Bioanalysis 12, no. 19 (2020): 1389–403. http://dx.doi.org/10.4155/bio-2020-0168.

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Background: Antibody biotherapeutic measurement from pharmacokinetic studies has not been traditionally based on intact molecular mass as is the case for small molecules. However, recent advancements in protein capture and mass spectrometer technology have enabled intact mass detection and quantitation for dosed biotherapeutics. A bioanalytical method validation is part of the regulatory requirement for sample analysis to determine drug concentration from in-life study samples. Results/methodology: Here, an intact protein LC–MS assay is subjected to mock bioanalytical method validation, and un

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Ge, Shencheng, Secil Koseoglu, and Christy L. Haynes. "Bioanalytical tools for single-cell study of exocytosis." Analytical and Bioanalytical Chemistry 397, no. 8 (2010): 3281–304. http://dx.doi.org/10.1007/s00216-010-3843-0.

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10

Bouchafra, Houda, Aimen El Orche, Choukri El Khabbaz, et al. "Determination and validation of tiaprofenic acid in human plasma: A detailed LC-MS/MS-based analysis following ICH M10 guidelines and the accuracy profile approach." Current Chemistry Letters 13, no. 4 (2024): 707–16. http://dx.doi.org/10.5267/j.ccl.2024.4.003.

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The validation of bioanalytical methods holds critical importance for regulatory agencies and organizations dedicated to ensuring the safety, efficacy, and quality of pharmaceuticals. In this context, the recent release of the ICH M10 guideline in May 2022 represents a significant milestone in standardizing bioanalytical method validation globally. However, this guideline lacks explicit experimental protocols for implementation. In this study, we address the practical implementation of the newly released ICH M10 guideline by providing a detailed validation protocol for a bioanalytical method.

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Sonawane, Dipali, Anuradha Reddy, Tarang Jadav, Amit K. Sahu, Rakesh K. Tekade, and Pinaki Sengupta. "Advancements in practical and scientific bioanalytical approaches to metabolism studies in drug development." Bioanalysis 13, no. 11 (2021): 913–30. http://dx.doi.org/10.4155/bio-2021-0050.

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Advancement in metabolism profiling approaches and bioanalytical techniques has been revolutionized over the last two decades. Different in vitro and in vivo approaches along with advanced bioanalytical techniques are enabling the accurate qualitative and quantitative analysis of metabolites. This review summarizes various modern in vitro and in vivo approaches for executing metabolism studies with special emphasis on the recent advancement in the field. Advanced bioanalytical techniques, which can be employed in metabolism studies, have been discussed suggesting their particular application b

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K, Santha Kumari, Mohan S, and Prasada Rao K. "Novel Quantitative Estimation of Rucaparib and Bevacizumab in Rat Plasma Using LC-MS/MS & Study of Pharmacokinetics." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 15, no. 03 (2024): 1109–14. http://dx.doi.org/10.25258/ijpqa.15.3.01.

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Rucaparib and Bevacizumab‘s bioanalytical evaluation was performed using an easy-to-use, effective, and repeatable LC-MS/ MS technique, with D6-Rucaparib and D6-Bevacizumab serving as internal standards. This work provides a summary of current developments in bioanalytical LC-MS/MS techniques using an organic mobile phase consisting of 50:50 formic acid and acetonitrile IN 0.1% as well as a Waters Symmetry C18 column. The results for stability, matrix effect, accuracy, precision, and recovery were all within allowable bounds. To test the targeted analytes in body fluids using pharmacokinetic r

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Pilli, Nageswara R., Suresh Narayanasamy, Lin Xu, et al. "A high-throughput bioanalytical assay to support pharmacokinetic interaction study of oxycodone and diazepam in Sprague Dawley rats." RSC Advances 10, no. 2 (2020): 886–96. http://dx.doi.org/10.1039/c9ra05785d.

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A high-throughput bioanalytical method for the simulataneous determination of oxycodone and diazepam to support the evaluation of respiratory depression in rats upon co-administration of oxycodone and diazepam.

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Blanchaert, Bart, Ismail Murat Palabiyik, Alper Gökbulut, et al. "Bioanalytical LC/MS study of potential bacterial transglycosylation inhibitors." Journal of Pharmaceutical and Biomedical Analysis 127 (August 2016): 123–28. http://dx.doi.org/10.1016/j.jpba.2015.12.050.

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15

Wibowo, Ari, Shabrina Nurbaiti, and Vitarani Dwi Ananda Ningrum. "Bioanalytical Method Validation for the Determination of Warfarin in Spiked-Saliva Using Fluorometric HPLC for TDM Application." Advanced Materials Research 1162 (April 2021): 173–79. http://dx.doi.org/10.4028/www.scientific.net/amr.1162.173.

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Saliva becomes an alternative biological matrix for therapeutic drug monitoring (TDM) application since there is a strong correlation between warfarin plasma concentration and saliva; further, the sampling is non-invasive and more comply with pediatric and geriatric patients. This study aims to validate the parameters of the warfarin bioanalytical method in spiked-saliva according to the criteria from the Food and Drug Administration (FDA) in the Guidance for Industry Bioanalytical Method Validation. The method used is Fluorometric HPLC with an excitation wavelength of 310 nm and an emission w

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Rakesh Shelke, Rakesh Shelke, and Dinesh Rishipathak. "Recent Upgradation in Bioanalytical Studies." Biosciences Biotechnology Research Asia 19, no. 1 (2022): 121–40. http://dx.doi.org/10.13005/bbra/2972.

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Analytical methodologies are critical throughout the medicine development process, including marketing and post-marketing studies. The advancement of bio-analytical techniques has resulted in a dynamic field with many exciting potentials for further advancement in the future. Bio-analysis is commonly utilised in the pharmaceutical drug development of drug's and its metabolites' quantitative levels. The goal is to undertake pharmacokinetic and pharmacodynamic studies, as well as kinetics, toxicokinetics, bioequivalence, and exposure studies. Bioanalytical research employs a variety of bioanalyt

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Tijare, Lokesh Khushalrao, Rangari Nt, and Mahajan Un. "A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION." Asian Journal of Pharmaceutical and Clinical Research 9, no. 9 (2016): 6. http://dx.doi.org/10.22159/ajpcr.2016.v9s3.14321.

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ABSTRACTIn this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should beapplied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and theirmetabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokineticstudies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigatedto dec

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Kammoun, Ahmed K., Alaa Khedr, and Osama A. A. Ahmed. "LC-MS/MS determination of avanafil and its metabolites in rat plasma and brain: pharmacokinetic study after oral administration and transdermal film application." RSC Advances 10, no. 16 (2020): 9407–13. http://dx.doi.org/10.1039/d0ra00569j.

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Mujewar, Imran N., Omprakash G. Bhusnure, Sneha R. Jagtap, Sachin B. Gholve, Padmaja S. Giram, and Atul B. Savangikar. "A Review on Bioanalytical Method Development and Various Validation Stages Involved In Method Development Using RP- HPLC." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 789–95. http://dx.doi.org/10.22270/jddt.v9i4-s.3422.

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Bioanalysis is an essential part in drug discovery and development. Bioanalysis is related to the analysis of analytes (drugs, metabolites, biomarkers) in biological samples and it involves several steps from sample collection to sample analysis and data reporting. The first step is sample collection from clinical or preclinical studies; then sending the samples to laboratory for analysis. Second step is sample preparation and it is very important step in bioanalysis. In order to reach reliable results, a robust and stable sample preparation method should be applied. The role of sample prepara

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Mylnikov, P. Yu, A. V. Shchulkin, Yuliya Vladimirovna Abalenikhina, and E. N. Yakusheva. "Development and validation of a methodology for quantitative determination of malondialdehyde by HPLC-MC/MS." Russian Clinical Laboratory Diagnostics 67, no. 7 (2022): 369–73. http://dx.doi.org/10.51620/0869-2084-2022-67-7-369-373.

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A bioanalytical technique for quantitative determination of MDA by HPLC-MS/MS. The proposed method for determining MDA includes the release stage of bound MDA and excludes the derivatization reaction. The lower limit of quantitative detection was 600 nmol/l, the volume of the required sample was 10 µl, the analysis time was 7 min. The range of concentrations obtained during the study makes it possible to use this bioanalytical technique to determine the concentration of MDA in biological material when assessing physiological and pathological conditions.

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21

Burckhardt, Bjoern B., and Stephanie Laeer. "Sample Preparation and Extraction in Small Sample Volumes Suitable for Pediatric Clinical Studies: Challenges, Advances, and Experiences of a Bioanalytical HPLC-MS/MS Method Validation Using Enalapril and Enalaprilat." International Journal of Analytical Chemistry 2015 (2015): 1–11. http://dx.doi.org/10.1155/2015/796249.

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In USA and Europe, medicines agencies force the development of child-appropriate medications and intend to increase the availability of information on the pediatric use. This asks for bioanalytical methods which are able to deal with small sample volumes as the trial-related blood lost is very restricted in children. Broadly used HPLC-MS/MS, being able to cope with small volumes, is susceptible to matrix effects. The latter restrains the precise drug quantification through, for example, causing signal suppression. Sophisticated sample preparation and purification utilizing solid-phase extracti

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Sandomenico, Annamaria, Valeria Severino, Angela Chambery, et al. "A Comparative Structural and Bioanalytical Study of IVIG Clinical Lots." Molecular Biotechnology 54, no. 3 (2013): 983–95. http://dx.doi.org/10.1007/s12033-013-9655-7.

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23

Kieres, Weronika, Sonia Kudłacik-Kramarczyk, Joanna Marczyk, et al. "Hydrogel Microarray for Bioanalytical Applications: Preliminary Study on Material Properties." Materials 18, no. 13 (2025): 3118. https://doi.org/10.3390/ma18133118.

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The aim of this study was to develop and characterize UV-crosslinked hydrogel matrices based on polyethylene glycol diacrylate (PEGDA), gum arabic, betaine, and sodium alginate for potential bioanalytical applications. Various physicochemical analyses were performed, including pre-polymerization emulsion stability (Multiscan), FT-IR spectroscopy, swelling behavior in physiological buffers, pH monitoring, contact angle measurements, and morphological assessment via SEM and optical microscopy. The results demonstrated that both alginate content and UV exposure time significantly influence the st

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Valluri, Venkat Rao, Naresh Kumar Katari, Chirag Khatri, Pankaj Kasar, Srinivasa Rao Polagani, and Sreekanth Babu Jonnalagadda. "A novel LC-MS/MS method for simultaneous estimation of acalabrutinib and its active metabolite acalabrutinib M₂₇ in human plasma and application to a human pharmacokinetic study." RSC Advances 12, no. 11 (2022): 6631–39. http://dx.doi.org/10.1039/d1ra09026g.

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A simple, specific, selective and accurate bioanalytical method was developed and validated for simultaneous estimation of acalabrutinib and its active metabolite in human plasma using liquid chromatography-tandem mass spectrometry (LC-MS/MS).

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Yaichkov, I. I., A. L. Khokhlov, M. K. Korsakov, A. A. Shetnev, N. N. Volkhin, and S. S. Petukhov. "Pharmacokinetics Study of a New Isoxazole Derivative in Rats Using HPLC-MS/MS for Blood Sample Analysis." Regulatory Research and Medicine Evaluation 14, no. 3 (2024): 304–16. http://dx.doi.org/10.30895/1991-2919-2024-14-3-304-316.

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INTRODUCTION. Systemic exposure studies of a selective carbonic anhydrase II inhibitor, the isoxazole derivative 5-[5-(trifluoromethyl)-1,2-oxazole-3-yl]-furan-2-sulfonamide (TFISA), require evaluating its pharmacokinetics in whole blood because the compound can accumulate in erythrocytes. Currently, no bioanalytical procedures have been developed to achieve this.AIM. This study aimed to develop a bioanalytical procedure for the determination of TFISA and its metabolites (N-hydroxy-5-[5-(trifluoromethyl)-1,2-oxazole-3-yl]-furan-2-sulfonamide and N-acetyl-5-[5-(trifluoromethyl)-1,2-oxazole-3-yl

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Wibowo, Ari, Vitarani D. A. Ningrum, and Rahma N. Ilhamy. "Method Validation for the Determination of Carbamazepine in Spiked-saliva Using HPLC-UV for Therapeutic Drug Monitoring Application." Current Psychopharmacology 9, no. 3 (2020): 234–41. http://dx.doi.org/10.2174/2211556009999200727191226.

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Background:: Carbamazepine has been used in the treatment of bipolar disorder, both in acute mania and maintenance therapy, particularly in developing countries. Not only its interaction with various drugs and auto-inducer nature, but the narrow therapeutic range of carbamazepine also makes monitoring necessary to guarantee the adequacy of its safety and therapeutic concentration. To date, the most common biological specimen used for therapeutic drug monitoring (TDM) purposes is still plasma, but saliva can become an alternative biological matrix since its level in saliva strongly correlates w

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Reddy, Venkata Krishna, Narayana Swamy, Rajeswari Rathod, and Pinaki Sengupta. "A Bioanalytical Method for Eliglustat Quantification in Rat Plasma." Journal of Chromatographic Science 57, no. 7 (2019): 600–605. http://dx.doi.org/10.1093/chromsci/bmz033.

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Abstract A simple and sensitive bioanalytical HPLC–UV method has been developed and validated for quantification of eliglustat in rat plasma. The liquid–liquid extraction method was found to be more efficient compared to protein precipitation technique. Chromatographic separation of eliglustat was achieved using Kromasil C18 column with a mobile phase consisting of a mixture of methanol and ammonium acetate (pH 3.2) in a ratio of 60:40. Detection wavelength was set at 282 nm. The developed method was specific, accurate, precise with good recovery and stability profile. The calibration curve co

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Fu, Yunlin, Deborah Barkley, Wenkui Li, Franck Picard, and Jimmy Flarakos. "Evaluation, identification and impact assessment of abnormal internal standard response variability in regulated LC−MS bioanalysis." Bioanalysis 12, no. 8 (2020): 545–59. http://dx.doi.org/10.4155/bio-2020-0058.

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Internal standard (IS) plays an important role in LC−MS bioanalysis by compensating for the variability of the analyte of interest in bioanalytical workflow. Due to the complexity of biological sample compositions and bioanalytical processes, a certain level of IS response variability across a run or a study is anticipated. However, an extensive variability may raise doubts to the accuracy of the measured results and also suggest nonoptimal analytical method. In this current paper, recent publications and guidelines regarding IS response in LC−MS bioanalysis were thoroughly reviewed with focus

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Roadcap, Brad, Azher Hussain, Dan Dreyer, et al. "Clinical application of volumetric absorptive microsampling to the gefapixant development program." Bioanalysis 12, no. 13 (2020): 893–904. http://dx.doi.org/10.4155/bio-2020-0074.

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In this paper we show the application of the Tasso OnDemand™, a novel automated sample collection device, in conjunction with volumetric absorptive microsampling (VAMS) for the development of gefapixant, a P2X3 receptor antagonist currently under clinical development for the treatment of refractory and unexplained chronic cough and endometriosis-related pain. A LC–MS/MS bioanalytical method was developed and validated using VAMS to support this development program. This method was utilized in a drug–drug interaction study to establish a mathematical bridging relationship with data obtained fro

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Xun, Zhiyin, Brad Yuska, Phillip Wang, and Swamy Yeleswaram. "Bioanalysis of INCB000928 in human saliva: nonspecific binding and inhomogeneous concentration." Bioanalysis 14, no. 7 (2022): 405–19. http://dx.doi.org/10.4155/bio-2022-0016.

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Aim: To develop a bioanalytical method for quantifying INCB000928 in human saliva. Materials & methods: Human centrifuged saliva and human whole saliva were compared for matrix selection. Protein precipitation extraction and HPLC–MS/MS was used for analysis. Results & conclusion: Nonspecific binding of INCB000928 was reduced in whole versus centrifuged saliva. Whole saliva was a preferred matrix for INCB000928 bioanalytical method validation. Incurred sample reanalysis (ISR) using a successfully validated method failed in a healthy volunteer study because of inhomogeneous INCB000928 co

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Depieri, Lívia Vieira, Fabíola Silva Garcia Praça, Patrícia Mazureki Campos, and Maria Vitória Lopes Badra Bentley. "Advances in the bioanalytical study of drug delivery across the skin." Therapeutic Delivery 6, no. 5 (2015): 571–94. http://dx.doi.org/10.4155/tde.15.20.

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Trevithick, C. C., M. M. Chartrand, J. Wahlman, F. Rahman, M. Hirst, and J. R. Trevithick. "Shaken, not stirred: bioanalytical study of the antioxidant activities of martinis." BMJ 319, no. 7225 (1999): 1600–1602. http://dx.doi.org/10.1136/bmj.319.7225.1600.

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Bouhajib, Mohammed, and Zia Tayab. "A Pharmacokinetic Evaluation of Dabigatran Etexilate, Total Dabigatran, and Unconjugated Dabigatran Following the Administration of Dabigatran Etexilate Mesylate Capsules in Healthy Male and Female Subjects." Drug Research 70, no. 01 (2019): 33–40. http://dx.doi.org/10.1055/a-1025-0119.

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Abstract Purpose Due to bioanalytical limitations it was previously not possible to evaluate the pharmacokinetics of dabigatran etexilate. We have developed validated methods to assay dabigatran etexilate, unconjugated dabigatran, and total dabigatran that will allow for a complete investigation into the pharmacokinetics of dabigatran etexilate mesylate. This study was designed to evaluate the pharmacokinetics of these analytes in healthy subjects. Methods This was an open-label, single-dose, one-period, one-treatment study. A single oral dose of dabigatran etexilate mesylate capsule containin

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Tang, Janet Y. M., Mauricio Taulis, Jacinta Edebeli, et al. "Chemical and bioanalytical assessment of coal seam gas associated water." Environmental Chemistry 12, no. 3 (2015): 267. http://dx.doi.org/10.1071/en14054.

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Environmental context Water associated with coal seam gas is generally of poor quality and thus its management and potential further usage is a subject of concern. In a comprehensive study involving chemical and bioanalytical assessments of coal seam gas associated water, we found that less than 5% of the biological effects could be explained by chemical analysis. The use of bioanalytical tools to complement chemical analysis is recommended for monitoring the quality of water associated with coal seam gas. Abstract A comprehensive study was undertaken involving chemical (inorganic and organic)

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Zagade, Aarati Dilip, Amit Shard, Shital Shinde, Amit Kumar Sahu, and Pinaki Sengupta. "Bioanalysis and Quadrupole-Time of Flight-Mass Spectrometry Driven In Vitro Metabolite Profiling of a New Boronic Acid-Based Anticancer Molecule." Journal of Chromatographic Science 58, no. 9 (2020): 796–803. http://dx.doi.org/10.1093/chromsci/bmaa044.

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Abstract (E/Z)-(4-(3-(2-((4-chlorophenyl)amino)-4-(dimethylamino)thiazol-5-yl)-2-(ethoxy carbonyl)-3-oxoprop-1-en-1-yl)phenyl) boronic acid, a newly developed molecule having anticancer activity serves as a potential candidate for the further drug development process. In this study, to ascertain the anticancer potential of the molecule, we screened it against different cell lines and compared the activity against the standard drug doxorubicin. The molecule showed promising activity at a low concentration against almost all cell lines used in the study. Apart from that, the molecule was charact

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Ha, Eun-Sol, Dong-Gyun Han, Seong-Wook Seo, et al. "A Simple HPLC Method for the Quantitative Determination of Silybin in Rat Plasma: Application to a Comparative Pharmacokinetic Study on Commercial Silymarin Products." Molecules 24, no. 11 (2019): 2180. http://dx.doi.org/10.3390/molecules24112180.

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Silybin (SBN) is a major active constituent of silymarin, a mixture of flavonoids found in fruits and seeds of milk thistle. The aim of this study was to describe a simple bioanalytical method for quantifying SBN in rat plasma. A simple protein deproteinization procedure with acetonitrile (ACN) was employed for plasma sample preparation. A reversed column and gradient elution of a mobile phase (mixture of phosphate buffer (pH 5.0) and ACN) were used for chromatographic separation. The selectivity, linearity (50–5000 ng/mL), precision, accuracy, recovery, matrix effect, and stability for this m

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Levchenko, Svitlana M., Artem Pliss, and Junle Qu. "Fluorescence lifetime imaging of fluorescent proteins as an effective quantitative tool for noninvasive study of intracellular processes." Journal of Innovative Optical Health Sciences 11, no. 01 (2017): 1730009. http://dx.doi.org/10.1142/s1793545817300099.

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Fluorescence lifetime imaging (FLIM) is an effective noninvasive bioanalytical tool based on measuring fluorescent lifetime of fluorophores. A growing number of FLIM studies utilizes genetically engineered fluorescent proteins targeted to specific subcellular structures to probe local molecular environment, which opens new directions in cell science. This paper highlights the unconventional applications of FLIM for studies of molecular processes in diverse organelles of live cultured cells.

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Hashii, Noritaka, Yoshiko Tousaka, Koji Arai, et al. "Generic MS-based method for the bioanalysis of therapeutic monoclonal antibodies in nonclinical studies." Bioanalysis 12, no. 4 (2020): 231–43. http://dx.doi.org/10.4155/bio-2019-0253.

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Aim: A generic bioanalytical method was developed to quantify therapeutic IgG1 monoclonal antibodies (mAbs) in mouse sera by combining an easy sample preparation method with LC/MS using selected reaction monitoring. Materials & methods: Rituximab and trastuzumab were used as model mAbs. A synthetic stable isotope-labeled peptide or a stable isotope-labeled mAb was used as an internal standard. The method feasibility was evaluated by a collaborative study involving six laboratories. Results: The calibration curve ranged from 1.0 to 1000.0 μg/ml (correlation coefficient >0.99). The valida

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Broders, Olaf, Uwe Wessels, Markus Zadak, Roland Beckmann, and Kay Stubenrauch. "Novel bioanalytical method for the characterization of the immune response directed against a bispecific F(ab) fragment." Bioanalysis 12, no. 8 (2020): 509–17. http://dx.doi.org/10.4155/bio-2020-0064.

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Aim: The work was aimed at developing a bioanalytical approach to identify immunogenic parts of a bispecific F(ab) fragment and to characterize the immune response seen in a preclinical study. Experimental: The bioanalytical method consists of a set of domain detection assays that use germlined variants of the drug. Results: The method demonstrated that anti-drug antibodies (ADAs) were predominantly directed against both antigen-binding sites of the drug. Conclusion: The method was capable to discriminate between ADAs directed against one of the antigen-binding sites, both sites or the constan

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Wickremsinhe, Enaksha R., Catherine L. Brockus, and Anthony T. Murphy. "Lessons learned from the COVID-19 pandemic and its impact on bioanalysis and drug development." Bioanalysis 13, no. 15 (2021): 1205–11. http://dx.doi.org/10.4155/bio-2021-0120.

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The COVID-19 pandemic challenged pharmaceutical and bioanalytical communities at large, in the development of vaccines and therapeutics as well as supporting ongoing drug development efforts. Existing processes were challenged to manage loss of staffing at facilities along with added workloads for COVID-19-related study support including conducting preclinical testing, initiating clinical trials, conducting bioanalysis and interactions with regulatory agencies, all in an ultra-rapid timeframes. A key factor of success was creative rethinking of processes and removing barriers – some of which h

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Navamanisubramanian, Raja, Shanmuganathan Seetharaman, Abimanyu Sugumaran, Mona Y. Alsheikh, Ibrahim A. Naguib, and Mohammed Gamal. "Affordable and Reliable RP-HPLC Method for Verapamil Hydrochloride Quantification in Rabbit Plasma for Pharmacokinetics." Processes 12, no. 10 (2024): 2211. http://dx.doi.org/10.3390/pr12102211.

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Background: Existing bioanalytical methods for verapamil hydrochloride (VH) are often complex, requiring advanced instrumentation and specialized expertise, which limits their use in resource-constrained laboratories. Aim: The goal of this study is to fill this gap by developing a simplified, robust RP-HPLC-UV approach for the estimation of verapamil hydrochloride in rabbit plasma. Designed to enhance accuracy and precision while minimizing sample preparation challenges, this method addresses existing limitations by providing an affordable and reliable alternative for laboratories lacking soph

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Wickremsinhe, Enaksha R., and Lisa B. Lee. "Quantification of abemaciclib and metabolites: evolution of bioanalytical methods supporting a novel oncolytic agent." Bioanalysis 13, no. 9 (2021): 711–24. http://dx.doi.org/10.4155/bio-2021-0039.

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Aim: Bioanalytical methods undergo many revisions and modifications throughout drug development to meet the objectives of the study and development program. Results: Validated LC–MS/MS methodology used to quantify abemaciclib and four metabolites in human plasma is described. The method, initially validated to support the first-in-human study, was successfully modified to include additional metabolites as in vitro and in vivo information about the activity and abundance of human metabolites became available. Consistent performance of the method over time was demonstrated by an incurred sample

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Komarov, Alexander A., and Elizaveta N. Goncharova. "PROOF OF BIOEQUIVALENCE OF DRUGS – AN EFFECTIVE TOOL FOR ACHIEVEMENT OF IMPORT INDEPENDENCE IN VETERINARY." Problems of veterinary sanitation, hygiene and ecology 3, no. 51 (2024): 449–53. http://dx.doi.org/10.36871/vet.san.hyg.ecol.202403019.

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Bioequivalence is an effective method of study and a tool for registration of generic drugs and generics. The most effective design for bioequivalence studies is a crossover design; a parallel design is less commonly used when it is not possible to use a crossover design, which reduces the likelihood of error. When studying bioequivalence, reliable validated bioanalytical methods are used. And the obtained indicators are analyzed using analysis of variance (ANOVA). This takes into account the influence of factors such as differences between drugs, individual differences between animals, the se

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Blaškovičová, Jana, and Ján Labuda. "Analytical methods in herpesvirus genomics." Acta Chimica Slovaca 7, no. 2 (2014): 109–18. http://dx.doi.org/10.2478/acs-2014-0019.

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Abstract Genomics is a branch of bioanalytical chemistry characterized as the study of the genome structure and function. Genome represents the complete set of chromosomal and extrachromosomal genes of an organism, a cell, an organelle or a virus. There are at least five from eight species of herpesviruses commonly widespread among humans, Herpes simplex virus type 1 and 2, Varicella zoster virus, Epstein-Barr virus and Cytomegalovirus. Human gammaherpesviruses can cause serious diseases including B-cell lymphoma and Kaposi’s sarcoma. Diagnostics and study of the herpesviruses is directly depe

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Kim, Jin Hyeok, Dan Gao, Chong Woon Cho, Inkyu Hwang, Hyung Min Kim, and Jong Seong Kang. "A Novel Bioanalytical Method for Determination of Inotodiol Isolated from Inonotus Obliquus and Its Application to Pharmacokinetic Study." Plants 10, no. 8 (2021): 1631. http://dx.doi.org/10.3390/plants10081631.

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In this study, we developed a bioanalytical method using liquid chromatography coupled to triple quadrupole tandem mass spectrometry (LC-MS/MS) to apply to a pharmacokinetic study of inotodiol, which is known for its anti-cancer activity. Plasma samples were prepared with alkaline hydrolysis, liquid–liquid extraction, and solid-phase extraction. Inotodiol was detected in positive mode with atmospheric pressure chemical ionization by multiple-reaction monitoring mode using LC-MS/MS. The developed method was validated with linearity, accuracy, and precision. Accuracy ranged from 97.8% to 111.9%,

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Pan, Luying, Kelly Hilton, Marie Nadeau, Thomas McCauley, and Yongchang Qiu. "A comparison study of bioanalytical methods for characterization of anti-idursulfase antibodies." Bioanalysis 9, no. 16 (2017): 1237–46. http://dx.doi.org/10.4155/bio-2017-0091.

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Al, Selen, and Olcay Sagirli. "Application of salt-assisted liquid extraction in bioanalytical methods." Euchembioj Reviews, no. 1 (October 15, 2024): 70–80. http://dx.doi.org/10.62063/rev-13.

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This review provides a comprehensive analysis of bioanalytical methods employed for the quantification of drug molecules in various biological matrices, including human plasma, urine, breast milk, and mouse plasma. The study not only examines traditional sample preparation techniques such as protein precipitation (PP), liquid-liquid extraction (LLE), and solid-phase extraction (SPE), but also delves into the relatively new and innovative salting-assisted liquid-liquid extraction (SALLE). It offers a thorough comparison of analytical methods utilizing SALLE, focusing on key parameters such as a

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Parachalil, Drishya Rajan, Clément Bruno, Franck Bonnier, et al. "Raman spectroscopic screening of high and low molecular weight fractions of human serum." Analyst 144, no. 14 (2019): 4295–311. http://dx.doi.org/10.1039/c9an00599d.

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This study explores the suitability of Raman spectroscopy as a bioanalytical tool, when coupled with ultra-filtration and multivariate analysis, to detect imbalances in both high molecular weight and low molecular weight fractions of the same samples of human patient serum, in the native liquid form.

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Benoist, Mette, Eric van der Meulen, Inge Van Oort, et al. "Development and validation of a bioanalytical assay on LC/MS/MS to quantify enzalutamide and N-desmethylenzalutamide in human plasma." Journal of Clinical Oncology 34, no. 2_suppl (2016): 330. http://dx.doi.org/10.1200/jco.2016.34.2_suppl.330.

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330 Background: To study the relation between drug exposure and therapeutic effect of enzalutamide and its equipotent metabolite N-desmethylenzalutamide, a bioanalytical assay on liquid chromatography tandem mass spectrometry (LC-MS/MS) was developed and validated to determine plasma concentrations in vivo. Methods: Plasma samples were diluted 10-fold with 20% albumin solution. Protein precipitation with acetonitrile was used to pretreat the diluted plasma. A stable isotope (D6-enzalutamide) was used as the internal standard. During validation five quality controls were used (LLOQ, LQ, MQ, HQ,

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Tubić, Biljana K., Sandra S. Vladimirov, and Bojan D. Marković. "INTER-LABORATORY REPRODUCIBILITY OF BIOANALYTICAL UHPLC-MS/MS METHOD." International Journal "Advanced Quality" 45, no. 2 (2017): 49. http://dx.doi.org/10.25137/ijaq.n2.v45.y2017.p49-53.

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Method validation is a continuous process, as a part of a perpetual analytical method development and improvement. Requirements for full validation are defined by various guidelines. Nevertheless, partial validation and method transfer are not so clearly described and well defined.The aim of this study was to examine method transferability through full validation method transfer between two different laboratories and to demonstrate if this approach can be regarded as sufficient for cross-laboratory results comparison.Method transfer was done from the originator laboratory to the recipient labo

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