Relevant bibliographies by topics / Bioanalytical method development

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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 development'

Author: Grafiati
Published: 7 June 2025
Last updated: 2 August 2025

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Journal articles on the topic "Bioanalytical method development"

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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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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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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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Kapri, Anandi, Nitin Gupta, and Garima Raj. "BIOANALYTICAL METHOD DEVELOPMENT: AN UPDATED REVIEW." International Research Journal of Pharmacy 8, no. 9 (2017): 6–9. http://dx.doi.org/10.7897/2230-8407.089151.

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Tremblay, Guy. "A narrative for bioanalytical method development." Bioanalysis 9, no. 3 (2017): 233–34. http://dx.doi.org/10.4155/bio-2016-0287.

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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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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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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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Badola, Ashutosh, Preeti Joshi, and Preeti Kothiyal. "A General Review on Bioanalytical Method Development and Validation for LC-MSMS." International Journal of Trend in Scientific Research and Development Volume-2, Issue-4 (2018): 1340–47. http://dx.doi.org/10.31142/ijtsrd14203.

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Waikar, Sakshi S., Manisha Raut, Tejashree Dugaje, Vasim T. Pathan, Atul R. Bendale, and Anil G. Jadhav. "Extensive assessment of fundamental factors in the development and validation of bioanalytical methods: Highlighting accuracy and reliability." International Journal of Pharmaceutical Chemistry and Analysis 11, no. 4 (2024): 274–80. https://doi.org/10.18231/j.ijpca.2024.040.

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Bioanalysis is a pivotal method employed in the pharmaceutical industry for the quantitative analysis of drugs and their metabolites within biological samples. It plays a crucial role in various aspects of pharmaceutical research, including bioequivalence, pharmacokinetic, and toxicokinetic studies. Method development, validation, and sample analysis are integral components of bioanalytical processes, ensuring the accuracy and reliability of results. Throughout each stage of analysis, careful evaluation is required to identify and mitigate any potential sources of interference, such as environ
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Dissertations / Theses on the topic "Bioanalytical method development"

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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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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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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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Kunati, Sandeep Reddy. "DEVELOPMENT OF BIOANALYTICAL METHODS FOR QUANTITATIVE MEASUREMENT OF ANTICANCER AGENTS." Cleveland State University / OhioLINK, 2018. http://rave.ohiolink.edu/etdc/view?acc_num=csu1523439107242919.

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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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Feng, Ye. "DEVELOPMENT OF QUANTITATIVE BIOANALYTICAL METHODS FOR THE PHARMACOLOGICAL STUDIES OF ANTI-CANCER DRUGS." Cleveland State University / OhioLINK, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=csu1392249778.

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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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LIPARI, Elisa. "DEVELOPMENT AND QUALIFICATION OF BIOANALYTICAL METHODS FOR DEAMIDATED IFNβ-1a AND INVESTIGATION ABOUT THE MECHANISM OF ACTION". Doctoral thesis, Università degli Studi di Palermo, 2021. http://hdl.handle.net/10447/497430.

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Interferon beta-1a (IFNβ-1a) is a recombinant IFNβ with the tradename Rebif involved in several biological activities. Recently, it has been reported that artificial deamidation of IFNb-1a increases its biological response. Given the therapeutical potential, an investigation on the deamidated variant has been carried out via different approaches to discover the mechanism underlying this biological effect. The antiviral and immunomodulatory activity of deamidated cytokine was assessed using two precise and accurate cell-based assays. As expected, deamidated IFNβ-1a showed an increase in the bio
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Books on the topic "Bioanalytical method development"

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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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Book chapters on the topic "Bioanalytical method development"

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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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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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Loos, Walter J., Peter de Bruijn, and Alex Sparreboom. "Bioanalytical Methods in Clinical Drug Development." In Principles of Anticancer Drug Development. Springer New York, 2010. http://dx.doi.org/10.1007/978-1-4419-7358-0_3.

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Karnes, H. Thomas, and Kumar A. Shah. "Validation and Control of Bioanalytical Methods." In Cancer Drug Discovery and Development. Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-9135-4_8.

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Powell, Mark L., and Steve E. Unger. "Bioanalytical Methods: Challenges and Opportunities in Drug Development." In Applications of Pharmacokinetic Principles in Drug Development. Springer US, 2004. http://dx.doi.org/10.1007/978-1-4419-9216-1_2.

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Karnes, H. Thomas. "Validation and Control of Bioanalytical Methods in Clinical Drug Development." In Handbook of Anticancer Pharmacokinetics and Pharmacodynamics. Humana Press, 2004. http://dx.doi.org/10.1007/978-1-59259-734-5_7.

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Olah, Timothy V., Asoka Ranasinghe, Hongwei Zhang, et al. "The Development and Implementation of LC/MS-Based Bioanalytical Methods for the Quantification of Protein Therapeutics in Drug Discovery." In Characterization of Protein Therapeutics using Mass Spectrometry. Springer US, 2013. http://dx.doi.org/10.1007/978-1-4419-7862-2_3.

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Olah, T. V. "The Development and Implementation of Bioanalytical Methods Using LC-MS to Support ADME Studies in Early Drug Discovery and Candidate Selection." In Pharmacokinetic Challenges in Drug Discovery. Springer Berlin Heidelberg, 2002. http://dx.doi.org/10.1007/978-3-662-04383-7_8.

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Neue, Uwe Dieter, Eric S. Grumbach, Jeff R. Mazzeo, KimVan Tran, and Diane M. Wagrowski-Diehl. "Method development in reversed-phase chromatography." In Bioanalytical Separations. Elsevier, 2003. http://dx.doi.org/10.1016/s1567-7192(03)80007-4.

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N, V. Murali Krishna. "Bioanalytical Methods." In Analytical Methods for Drug Development. THINKPLUS PHARMA PUBLICATIONS, 2025. https://doi.org/10.69613/6x309b41.

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Bioanalytical methods quantify drugs and metabolites in biological matrices with high sensitivity and specificity. Bioavailability studies require analysis of plasma, urine, and tissue samples with extraction protocols tailored to drug properties and matrix complexities. Method selection considers sensitivity requirements, sample volumes, throughput needs, and available instrumentation. Pharmacokinetic analysis requires precise sample collection timing, stability controls, and accurate concentration measurements to generate time-profiles and calculate parameters like AUC, Cmax, and half-life.
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Conference papers on the topic "Bioanalytical method development"

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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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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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