Relevant bibliographies by topics / Bioanalytical method

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers

Academic literature on the topic 'Bioanalytical method'

Author: Grafiati
Published: 4 June 2021
Last updated: 26 July 2025

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Journal articles on the topic "Bioanalytical method"

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Anjani, M. Nikhare* R. T. Lohiya S. W. Rangari M. J. Umekar. "An Overview of the Development and Validation of Bioanalytical Methods using HPLC." International Journal of Pharmaceutical Sciences 2, no. 11 (2024): 319–25. https://doi.org/10.5281/zenodo.14045042.

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A key component of successful drug development is the creation of sensitive, dependable, and selective bioanalytical techniques for the quantitative assessment of medications and their metabolites in biological matrices. The pharmacokinetic and toxicokinetic analyses of investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs) all require the data gathered from these techniques. Critical judgments supporting a drug's safety and efficacy are based on the findings of human clinical trials, including bioavailability and bioequivalenc
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Kadam, Amruta S., Nayana V. Pimpodkar, Puja S. Gaikwad, and Sushila D. Chavan. "Bioanalytical Method Validation." Asian Journal of Pharmaceutical Analysis 5, no. 4 (2015): 219. http://dx.doi.org/10.5958/2231-5675.2015.00035.6.

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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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Rahul, Patil* Rajveer Bhaskar Monika Ola Diksha Pingale Shailesh Chalikwar. "BIOANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION IN HUMAN PLASMA BY USING LC MS/MS." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 03 (2019): 5176–83. https://doi.org/10.5281/zenodo.2591534.

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<em>Bioanalytical method development plays importance role in the pre-clinical and clinical studies. Pharmacokinetics of any drug and its metabolite can be recognized by bioanalytical studies. The quantitative analysis of drugs and their metabolite sin the biological media is done by bioanalytical studies. Physical-chemical and biological techniques are used for these studies. Every bioanalytical method should be selective, sensitive and reliable for the quantitative estimation in drug discovery process. Bioanalytical method development consists of sample preparation, chromatographic separatio
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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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Hill, Howard M., and Graeme Smith. "Method transfer between bioanalytical laboratories." Bioanalysis 7, no. 7 (2015): 783–87. http://dx.doi.org/10.4155/bio.15.37.

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Gelpí, E. "Bioanalytical aspects on method validation." Life Sciences 41, no. 7 (1987): 849–52. http://dx.doi.org/10.1016/0024-3205(87)90178-0.

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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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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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Gniazdowska, Elżbieta, Edyta Gilant, and Katarzyna Buś-Kwaśnik. "ICH M10 guideline - a harmonized global approach to bioanalysis." Prospects in Pharmaceutical Sciences 21, no. 3 (2023): 57–63. http://dx.doi.org/10.56782/pps.152.

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Bioanalytical methods are used in research on small-molecule and large-molecule drug products to determine analytes and their metabolites in biological matrices such as blood, plasma, serum, urine, feces, saliva, other biological fluids, or tissues. Validation of a bioanalytical method is the essential step before the implementation of the method into routine use in toxicokinetic or pharmacokinetic studies. Harmonization of recommendations for the validation of bioanalytical methods has been advocated for many years. In 2022, The International Council for Harmonisation of Technical Requirement
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Dissertations / Theses on the topic "Bioanalytical method"

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Malm, Mikaela. "Drug Analysis : Bioanalytical Method Development and Validation." Doctoral thesis, Uppsala universitet, Analytisk kemi, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-8547.

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This thesis describes bioanalytical methods for drug determination in biological matrixes, with drugs in focus used against diseases largely affecting low-income countries. Solid-phase extraction is used for sample cleanup, and processed samples are analyzed by liquid chromatography. Developed bioanalytical methods are validated according to international guidelines. Eflornithine (DFMO) is a chiral drug, used for treating human African trypanosomiasis. A bioanalytical method for determination of DFMO enantiomers in plasma is presented. The enantiomers are detected by evaporative light-scatteri
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Carmical, Jennifer, and Stacy D. Brown. "The Impact of Phospholipids and Phospholipid Removal on Bioanalytical Method Performance." Digital Commons @ East Tennessee State University, 2016. https://doi.org/10.1002/bmc.3686.

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Phospholipids (PLs) are a component of cell membranes, biological fluids and tissues. These compounds are problematic for the bioanalytical chemist, especially when PLs are not the analytes of interest. PL interference with bioanalysis highly impacts reverse-phase chromatographic methods coupled with mass spectrometric detection. Phospholipids are strongly retained on hydrophobic columns, and can cause significant ionization suppression in the mass spectrometer, as they out-compete analyte molecules for ionization. Strategies for improving analyte detection in the presence of PLs are reviewed,
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Cai, Xiaohan. "¿¿¿¿¿¿Development of Bioanalytical Methods for Clinical Applications and Drug Screening." Cleveland State University / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=csu1314982525.

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Hendriks, Gert. "Theoretical models in bioanalytical method development development and use of theoretical models in pharmaceutical bioanalysis of small molecules /." [S.l. : [Groningen : s.n.] ; University Library Groningen] [Host], 2009. http://irsw.ub.rug/nl/ppn/316.

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Ali, Mohsin [Verfasser]. "Bioanalytical method performance verification concept for cardiovascular research in pediatrics: From development to application in clinical trials / Mohsin Ali." Düsseldorf : Universitäts- und Landesbibliothek der Heinrich-Heine-Universität Düsseldorf, 2020. http://d-nb.info/1205544135/34.

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Oliveira, Maysa Aparecida de. "Obtenção e caracterização química e farmacocinética do produto de fotodegradação do nifedipino." Universidade Federal de Goiás, 2013. http://repositorio.bc.ufg.br/tede/handle/tede/8672.

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Submitted by Marlene Santos (marlene.bc.ufg@gmail.com) on 2018-07-09T16:12:59Z No. of bitstreams: 2 Tese- Maysa Aparecida de Oliveira - 2013.pdf: 2303389 bytes, checksum: d6b1b0186001f327c5e50809b8d401fb (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5)<br>Approved for entry into archive by Luciana Ferreira (lucgeral@gmail.com) on 2018-07-10T11:10:17Z (GMT) No. of bitstreams: 2 Tese- Maysa Aparecida de Oliveira - 2013.pdf: 2303389 bytes, checksum: d6b1b0186001f327c5e50809b8d401fb (MD5) license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5)<br>Mad
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Cannan, Susan. "Microelectrode methods for bioanalytical and biophysical applications." Thesis, University of Warwick, 2003. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.397013.

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Brown, Stacy D., and Tyler C. Melton. "Trends in Bioanalytical Methods for Club Drugs: 2000-2010." Digital Commons @ East Tennessee State University, 2011. https://doi.org/10.1002/bmc.1549.

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The term 'club drug' can be loosely defined as any substance used to enhance social settings. Such drugs are commonly found at raves or similar all-night dance parties and include methamphetamine, 3,4-methylenedioxymethamphetamine, gamma-hydroxybutyrate (GHB), ketamine (KET), and flunitrazepam (FLU). These drugs have potentially dangerous side effects including hallucinations, paranoia, amnesia and hyperthermia. In addition, GHB, KET and FLU are considered predatory drugs due to their roles in drug-facilitated sexual assault. Forensic and regulatory agencies routinely have the need for determi
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Gorityala, Shashank. "TARGETED AND UNTARGETED OMICS FOR DISEASE BIOMARKERS USING LC-MS." Cleveland State University / OhioLINK, 2018. http://rave.ohiolink.edu/etdc/view?acc_num=csu1547093694357568.

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Pihlblad, Alma. "Development and comparison of bioanalytical methods to measure free analyte." Thesis, Uppsala universitet, Institutionen för biologisk grundutbildning, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-413669.

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Free analyte is measured to be able to understand the pharmacological effects of a drug in the body, the binding to its ligand, and the effective drug level among other things. Thereby, it is important with correct measurements of free analyte, although it is not that easy to achieve since overestimations can occur. In this project, several immunoassays were developed for the bioanalytical methods Gyrolab and ELISA to measure free analyte, where the biotherapeutics Avastin® and Lucentis®, and the ligand VEGF were used as analytes. One difference between the methods is the short contact time of
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Books on the topic "Bioanalytical method"

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Vogel, Patric U. B. Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden, 2023. http://dx.doi.org/10.1007/978-3-658-38913-0.

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Van Emon, Jeanette M., 1956-, ed. Immunoassay and other bioanalytical techniques. CRC Press/Taylor & Francis, 2007.

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Christine T. C. Fook Sheung. The applicability of ASTED/HPLC to the development of bioanalytical methods. De Montfort University, 1996.

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Barceló, Damià. Biosensors for the environmental monitoring of aquatic systems: Bioanalytical and chemical methods for endocrine disruptors. Springer, 2009.

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Vogel, Patric U. B. Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden GmbH, 2022.

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Methods of Biochemical Analysis: Bioanalytical Instrumentation. Wiley-Interscience, 1993.

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Validation of Bioanalytical Methods and Document Bioequivalence (ANDA). CRC Press LLC, 1999.

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Biopolymer Mass Spectrometry: Methods, Ion Chemistry, Bioanalytical Applications. Wiley & Sons, Limited, John, 2018.

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Wells, David Ames, and Wells David. High Throughput Bioanalytical Sample Preparation: Methods and Automation Strategies. Elsevier Science & Technology Books, 2003.

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High Throughput Bioanalytical Sample Preparation - Methods and Automation Strategies. Elsevier, 2003. http://dx.doi.org/10.1016/s1464-3456(03)x8001-1.

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Book chapters on the topic "Bioanalytical method"

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Nahler, Gerhard. "bioanalytical method." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_117.

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Garofolo, Fabio. "Bioanalytical Method Validation." In Analytical Method Validation and Instrument Performance Verification. John Wiley & Sons, Inc., 2004. http://dx.doi.org/10.1002/0471463728.ch8.

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Vogel, Patric U. B. "Method Categories." In Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden, 2023. http://dx.doi.org/10.1007/978-3-658-38913-0_2.

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Lin, Zhongping John, Wenkui Li, and Naidong Weng. "Lc-Ms Bioanalytical Method Transfer." In Handbook of LC-MS Bioanalysis. John Wiley & Sons Inc., 2013. http://dx.doi.org/10.1002/9781118671276.ch6.

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Khan, Masood, and Naidong Weng. "Method Development for Preclinical Bioanalytical Support." In Preclinical Development Handbook. John Wiley & Sons, Inc., 2007. http://dx.doi.org/10.1002/9780470249031.ch4.

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Arnold, Mark E., Rafael E. Barrientos-Astigarraga, Fabio Garofolo, et al. "Current Regulations for Bioanalytical Method Validations." In Handbook of LC-MS Bioanalysis. John Wiley & Sons Inc., 2013. http://dx.doi.org/10.1002/9781118671276.ch4.

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Vogel, Patric U. B. "Errors, Problems and Risks Associated with Insufficient Method Validation." In Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden, 2023. http://dx.doi.org/10.1007/978-3-658-38913-0_6.

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Peters, Frank T., and Hans H. Maurer. "Bioanalytical method validation and its implications for forensic and clinical toxicology — A review." In Validation in Chemical Measurement. Springer Berlin Heidelberg, 2002. http://dx.doi.org/10.1007/3-540-27034-5_1.

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Li, Hongyan, Timothy Heath, and Christopher A. James. "LC-MS/MS Bioanalytical Method Development Strategy for Therapeutic Monoclonal Antibodies in Preclinical Studies." In Protein Analysis using Mass Spectrometry. John Wiley & Sons, Inc., 2017. http://dx.doi.org/10.1002/9781119371779.ch12.

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Stead, Sara, and Jacques Stark. "Bioanalytical Screening Methods." In Chemical Analysis of Antibiotic Residues in Food. John Wiley & Sons, Inc., 2011. http://dx.doi.org/10.1002/9781118067208.ch5.

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Conference papers on the topic "Bioanalytical method"

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Lytle, Fred E. "Identification of Bacterial Pathogens by Laser Excited Fluorescence." In Laser Applications to Chemical Analysis. Optica Publishing Group, 1987. http://dx.doi.org/10.1364/laca.1987.ma7.

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Aminopeptidase profiling is an established bioanalytical technique used for the identification of bacterial pathogens. This method is based on the production of highly fluorescent β-naphthylamine (BNA) through aminopeptidase hydrolysis of a series of nonfluorescent L-aminoacid-β-naphthylamide substrates by the microorganism of interest. The resultant profiles used to make the identification are bar graphs of the extent of hydrolysis of the substrate versus the identity of the nutrient. The shape of the plot is indicative of the pathogen.
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Spadafora, Debora, Manuel Daldin, Elisa Marchegiani, et al. "D002 Development of a new bioanalytical method for selective measurement of wild-type Huntingtin in human cerebrospinal fluid." In EHDN and Enroll-HD 2024 abstracts. BMJ Publishing Group Ltd, 2024. http://dx.doi.org/10.1136/jnnp-2024-ehdn.78.

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Yedlapalli, Govindarao, and Y. Ganesh Kumar. "Optimization of Bioanalytical Liquid Chromatography - Tandem Mass Spectrometric Method for Quantification of Tazemetostat: An Epithelioid Sarcoma Treatment Drug in Human Plasma." In 2023 12th International Conference on System Modeling & Advancement in Research Trends (SMART). IEEE, 2023. http://dx.doi.org/10.1109/smart59791.2023.10428339.

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RÜBENSAM, Gabriel, and Henrique Bordin Lucena BORGES. "VALIDATION OF A GC-FID METHODOLOGY FOR THE DETERMINATION OF 2,5-HEXANEDIONE IN URINE." In SOUTHERN BRAZILIAN JOURNAL OF CHEMISTRY 2021 INTERNATIONAL VIRTUAL CONFERENCE. DR. D. SCIENTIFIC CONSULTING, 2022. http://dx.doi.org/10.48141/sbjchem.21scon.33_abstract_borges.pdf.

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2,5-hexanedione is the main metabolite of hexane and methyl butyl ketone excreted into urine and is currently used to estimate the human exposure levels to these solvents in professional environments. In Brazil, occupational exposure is regulated by a national control program (PCMSO) and applied to public and private organizations that hire your employees according to the actual Brazilian legislation. In the present work, we validated a methodology based on a gas chromatography−flame ionization detector (GC-FID) for the quantification of 2,5-hexanedione in urine to attend the new occupational
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Narayanan, Narasimhachari, Garrick Little, Ramesh Raghavachari, and Gabor Patonay. "New near-infrared dyes for applications in bioanalytical methods." In Photonics West '95, edited by Joseph R. Lakowicz. SPIE, 1995. http://dx.doi.org/10.1117/12.208471.

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Castro, SM, LA Azevedo, S. Eller, et al. "DESENVOLVIMENTO DE MÉTODO ANALÍTICO PARA DETERMINAÇÃO DE ANTIEPILÉPTICOS EM AMOSTRAS DE SORO POR LC-MS/MS." In Resumos do 55º Congresso Brasileiro de Patologia Clínica/Medicina Laboratorial. Zeppelini Editorial e Comunicação, 2023. http://dx.doi.org/10.5327/1516-3180.141s2.8134.

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Objetivo: A terapia farmacológica com antiepilépticos (AE) apresenta faixa terapêutica estreita, de forma que é necessária a dosagem de AE em soro, a fim de proceder com a monitorização terapêutica e promover melhor resultado clínico. Atualmente, os principais métodos de análise de AE se baseiam em testes imunoquímicos, cujos resultados apresentam seletividade e especificidade limitados. Este estudo tem como objetivo desenvolver e validar método de determinação de quatro antiepilépticos usados tradicionalmente na clínica e presentes na RENAME (ácido valproico, carbamazepina, fenitoína e fenoba
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Lin, Hao, Rajiv Bharadwaj, Juan G. Santiago, and Bijan Mohammadi. "A High-Fidelity Electrokinetic Flow Model for the Prediction of Electrophoregrams in On-Chip Eletrophoresis Applications." In ASME 2005 International Mechanical Engineering Congress and Exposition. ASMEDC, 2005. http://dx.doi.org/10.1115/imece2005-79439.

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On-chip electrophoresis is a growing field with increasing chemical and bioanalytical applications such as genomics and proteomics. The use of multicomponent and heterogeneous electrolyte configurations can often lead to complex flow behavior. In this work, we present a high-fidelity, low computational cost electrokinetic flow model for the modeling and optimization of electrophoretic separations. The model adopts a depth-averaged approach that captures convective-dispersion processes, and includes important physical effects such as electrical body force and fully nonlinear multi-species elect
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