Relevant bibliographies by topics / Bioanalytical method validation

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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 validation'

Author: Grafiati
Published: 4 June 2025
Last updated: 1 August 2025

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Journal articles on the topic "Bioanalytical method validation"

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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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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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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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Sakshi, B. Tarle* Smita. S. Aher Durga. B. Zade Dr. Rushikesh. S. Bachhav. "An Approach To Bioanalytical Method Development And Validation: A Review." International Journal of Pharmaceutical Sciences 2, no. 7 (2024): 382–93. https://doi.org/10.5281/zenodo.12671255.

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The execution of all the steps necessary to show that a specific technique employed for the quantitative measurement of analytes in a given biological matrix (such as blood, plasma, serum, or urine) is reliable and consistent for the intended application. Three categories of bioanalytical validation exist: cross-validation, partial validation, and full validation. Accuracy, precision, linearity, selectivity and specificity, limit of detection, limit of quantitation, standard curve (calibration curve), recovery, stability, robustness, and ruggedness are among the important bioanalytical techniq
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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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Saudagar, R. B., and P. G. Thete. "Bioanalytical Method Validation: A Concise Review." Asian Journal of Research in Pharmaceutical Science 8, no. 2 (2018): 107. http://dx.doi.org/10.5958/2231-5659.2018.00019.x.

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Tiwari, Gaurav, and Ruchi Tiwari. "Bioanalytical method validation: An updated review." Pharmaceutical Methods 1, no. 1 (2010): 25. http://dx.doi.org/10.4103/2229-4708.72226.

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Buick, A. R., M. V. Doig, S. C. Jeal, G. S. Land, and R. D. McDowall. "Method validation in the bioanalytical laboratory." Journal of Pharmaceutical and Biomedical Analysis 8, no. 8-12 (1990): 629–37. http://dx.doi.org/10.1016/0731-7085(90)80093-5.

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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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Ali, Mohsin, Muhammad Usman, Huma Rasheed, et al. "A systematic review on chromatography-based method validation for quantification of vancomycin in biological matrices." Bioanalysis 12, no. 24 (2020): 1767–86. http://dx.doi.org/10.4155/bio-2020-0230.

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A fully validated bioanalytical methods are prerequisite for pharmacokinetic and bioequivalence studies as well as for therapeutic drug monitoring. Due to high pharmacokinetic variability and narrow therapeutic index, vancomycin requires reliable quantification methods for therapeutic drug monitoring. To identify published chromatographic based bioanalytical methods for vancomycin in current systematic review, PubMed and ScienceDirect databases were searched. The selected records were evaluated against the method validation criteria derived from international guidelines for critical assessment
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Dissertations / Theses on the topic "Bioanalytical method validation"

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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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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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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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Römsing, Susanne. "Development and Validation of Bioanalytical Methods : Application to Melatonin and Selected Anti-Infective Drugs." Doctoral thesis, Uppsala universitet, Analytisk kemi, 2010. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-131519.

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This thesis describes bioanalytical methods for measuring melatonin and some anti-infective drugs in biological fluids. Solid-phase extraction (SPE) or protein precipitation was used for enrichment and purification of the analytes and Liquid Chromatography (LC) was used to analyze the samples. Developed methods were validated according to international guidelines. Melatonin is a hormone secreted by the pineal gland with a robust circadian rhythm. Bioanalytical methods for determination of melatonin in plasma and saliva have been developed which were used for monitoring melatonin levels in volu
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Wang, Bo. "Novel statistical methods for evaluation of metabolic biomarkers applied to human cancer cell lines." Miami University / OhioLINK, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=miami1399046331.

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Meirinho, Sara Alexandra. "Bioanalytical method validation of Venlafaxine and Desvenlafaxine in mouse plasma, brain and liver using a MEPS/HPLC assay: a path to study these drugs’ intranasal administration." Master's thesis, 2015. http://hdl.handle.net/10400.6/6438.

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The present thesis was elaborated aiming to obtain the master’s degree in pharmaceutical sciences. In here, it is described all the scientific investigation work done to reach the proposed objective, as well as all tasks and learnings that I have taken along my community and hospital pharmacy internships. Chapter 1 is related with my scientific investigation work entitled “Bioanalytical method validation of Venlafaxine and Desvenlafaxine in mouse plasma, brain and liver using a MEPS/HPLC assay: a path to study these drugs’ intranasal administration”. Since major depressive disorder is one of t
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Caufield, William Vincent. "Development and validation of stability indicating high performance liquid chromatography methods for the analysis of selected pharmaceuticals in intravenous fluid mixtures ; development and validation of bioanalytical high performance liquid chromatography methods for the analysis of selected pharmaceuticals." 2002. http://purl.galileo.usg.edu/uga%5Fetd/caufield%5Fwilliam%5Fv%5F200205%5Fphd.

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Thesis (Ph. D.)--University of Georgia, 2002.<br>Directed by William Vincent Caufield. Includes articles published in Chromatographia, and an article accepted by Journal of liquid chromatography and related technologies. Includes bibliographical references.
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Books on the topic "Bioanalytical method validation"

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

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

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Book chapters on the topic "Bioanalytical method validation"

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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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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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Vogel, Patric U. B. "Validation of Bioanalytical Methods." In Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden, 2023. http://dx.doi.org/10.1007/978-3-658-38913-0_5.

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Vogel, Patric U. B. "Validation Environment and Validation Planning." In Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden, 2023. http://dx.doi.org/10.1007/978-3-658-38913-0_4.

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Vogel, Patric U. B. "Validation Parameters." In Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden, 2023. http://dx.doi.org/10.1007/978-3-658-38913-0_3.

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Vogel, Patric U. B. "Introduction." In Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden, 2023. http://dx.doi.org/10.1007/978-3-658-38913-0_1.

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Vogel, Patric U. B. "Summary." In Validation of Bioanalytical Methods. Springer Fachmedien Wiesbaden, 2023. http://dx.doi.org/10.1007/978-3-658-38913-0_7.

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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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Conference papers on the topic "Bioanalytical method validation"

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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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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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