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Journal articles on the topic 'Bioanalytical method development'

Author: Grafiati

Published: 7 June 2025

Last updated: 2 August 2025

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1

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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2

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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3

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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4

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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5

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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6

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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7

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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8

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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9

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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10

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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11

Sravanthi Gandu, Kumaraswamy Gandla, and Lalitha Repudi. "Green metric tools and white assessment in bioanalytical method development and validation: A comprehensive review." World Journal of Advanced Research and Reviews 26, no. 3 (2025): 1674–80. https://doi.org/10.30574/wjarr.2025.26.3.2362.

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The increasing demand for sustainable and eco-friendly practices in pharmaceutical and bioanalytical research has prompted the integration of green chemistry principles into analytical method development. This review discusses the implementation of Green Analytical Chemistry (GAC) metrics, such as Analytical Eco-Scale, Green Analytical Procedure Index (GAPI), and Analytical Greenness (AGREE), as well as the emerging White Analytical Chemistry (WAC) concept, in the development and validation of bioanalytical methods. We highlight the significance, methodology, and applications of these tools in

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12

Hendriks, G. "Theoretical models in LC based bioanalytical method development." Journal of Pharmaceutical and Biomedical Analysis 49, no. 1 (2009): 1–10. http://dx.doi.org/10.1016/j.jpba.2008.09.040.

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13

Reddy, Konatham Teja Kumar, Sudha Divya Madhuri Kallam, Anoop Bodapati, and Alapati Sahithi. "Review on Green Bioanalytical Chemistry with Sustainable Approaches in Method Development: Unveiling the Crucial Role of Sustainable Bioanalysis in the Future of Chemistry." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 15, no. 03 (2024): 1827–32. http://dx.doi.org/10.25258/ijpqa.15.3.110.

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Green bioanalytical chemistry, with its focus on incorporating sustainable practices into developing bioanalytical methods, has the potential to significantly reduce the environmental impact of laboratory activities. This approach, while maintaining the high standards required for analytical precision and accuracy, includes key strategies such as reducing hazardous chemicals, optimizing energy use, and implementing waste-reduction practices. This review highlights recent advancements in green bioanalytical chemistry, including green solvent systems, miniaturized techniques, and eco-friendly an

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14

Fountain, Mark E. "Bioanalytical method development: considering information from a suite of complementary methods." Bioanalysis 4, no. 2 (2012): 115–19. http://dx.doi.org/10.4155/bio.11.307.

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15

Singh, Swapna, Prem Kumar Bichala, Abhishek Agrwal, and Ravi Shankar Bhatnagar. "REVIEW: AN APPROACH TO BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION." International Journal of Pharmaceutical Sciences and Medicine 6, no. 1 (2021): 1–7. http://dx.doi.org/10.47760/ijpsm.2021.v06i01.001.

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16

Stoll, Dwight R. "Guidelines for bioanalytical 2D chromatography method development and implementation." Bioanalysis 2, no. 1 (2010): 105–22. http://dx.doi.org/10.4155/bio.09.131.

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17

Ma, Mark, Christopher Tudan, and Dolly Koltchev. "The 10th Annual Bioassays and Bioanalytical Method Development Conference." Bioanalysis 7, no. 5 (2015): 569–72. http://dx.doi.org/10.4155/bio.14.319.

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18

Kallam, Sudha Divya Madhuri, Anoop Bodapati, Alapati Sahithi Reddy, and Konatham Teja Kumar Reddy. "Bioanalytical method development for monoclonal antibodies: advances and challenges." Cellular, Molecular and Biomedical Reports 5, no. 1 (2025): 48–62. http://dx.doi.org/10.55705/cmbr.2025.463295.1249.

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19

Janiszewski, J. S., M. C. Swyden, and H. G. Fouda. "High-Throughput Method Development Approaches for Bioanalytical Mass Spectrometry." Journal of Chromatographic Science 38, no. 6 (2000): 255–58. http://dx.doi.org/10.1093/chromsci/38.6.255.

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20

Moein, Mohammad Mahdi, Aziza El Beqqali, and Mohamed Abdel-Rehim. "Bioanalytical method development and validation: Critical concepts and strategies." Journal of Chromatography B 1043 (February 2017): 3–11. http://dx.doi.org/10.1016/j.jchromb.2016.09.028.

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21

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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22

Jabeen, Nameera, and M. Akiful Haque. "A Review on Bioanalytical Method Development and Validation for Estimation of Drugs by Using Hyphenated Techniques and its Applications on Routine Analysis." Archives of Current Research International 23, no. 2 (2023): 18–35. http://dx.doi.org/10.9734/acri/2023/v23i2556.

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Bioanalytical methods are used to create a protocol that can identify and quantify bioactive molecules and their metabolites in human and animal samples. For determining the medication and its metabolites present in human/animal body, the bioanalytical method is efficient. One of the prominent bioanalytical roles is creating new techniques, validating existing processes, and analyzing samples. Most importantly, a compound can be calculated using many methods and can also be detected using various analytical methods. In specific biological samples, the drugs can be evaluated by different extrac

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23

Kolganova, Maria A., Elizaveta V. Melnik, Elizaveta N. Fisher, et al. "Affinity Capture Elution (ACE) ELISA Method Development and Validation for Novel RPH-104 Drug Immunogenicity Evaluation." Biomedicines 10, no. 11 (2022): 2750. http://dx.doi.org/10.3390/biomedicines10112750.

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As the number of therapeutic protein products is growing rapidly, there is a strong need for the development of bioanalytical methods that are easy to perform, specific, sensitive, robust, and affordable. Methods for immunogenicity evaluation of therapeutic proteins take an important place in this field of bioanalytics. The aim of the study was to develop a method for immunogenicity testing of the novel RPH-104 drug using the Affinity Capture Elution (ACE) ELISA technique. RPH-104 is a promising Interleukin-1 (IL-1) inhibitor that is currently undergoing a series of clinical studies, including

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24

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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25

Côté, Cynthia, Annik Bergeron, Jean-Nicholas Mess, Milton Furtado, and Fabio Garofolo. "Matrix effect elimination during LC–MS/MS bioanalytical method development." Bioanalysis 1, no. 7 (2009): 1243–57. http://dx.doi.org/10.4155/bio.09.117.

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26

Pushptode, Ankush, Ankit Diwan, and Kuldeep Ganju. "BIOANALYTICAL METHOD DEVELOPMENT AND ESTIMATION OF CEFOTAXIME USING RP-HPLC." Asian Journal of Pharmaceutical Education and Research 10, no. 3 (2021): 42. http://dx.doi.org/10.38164/ajper/10.3.2021.42-49.

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27

D’cruz, Delma, Anu Babu, and Eena Joshy. "BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TICAGRELOR BY RP-HPLC." International Journal of Applied Pharmaceutics 9, no. 3 (2017): 51. http://dx.doi.org/10.22159/ijap.2017v9i3.17452.

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Objective: The main purpose of this study was to develop a simple, precise, rapid and accurate RP-HPLC method for the quantitative determination of ticagrelor in human plasma. Methods: The separation was accomplished by the isocratic method by utilizing phenomenex C18 column on a Shimadzu binary gradient liquid chromatography system furnished with LC-20AD solvent delivery system, SPD-20-A photo-diode array detector and 20 µl loop volume in a rheodyne injector. The analyte was extracted by protein precipitation in the involvement of diethyl ether as a protein precipitator. The mobile phase was

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28

Xue, Y. J., Brian Melo, Martha Vallejo, et al. "An integrated bioanalytical method development and validation approach: case studies." Biomedical Chromatography 26, no. 10 (2011): 1215–27. http://dx.doi.org/10.1002/bmc.2682.

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29

Mansour, Noura, Dina El-Sherbiny, Fawzia Ibrahim, and Hussein El-Subbagh. "Review on bioanalytical and analytical method development of Antiepileptic racetams." Delta University Scientific Journal 5, no. 2 (2022): 53–62. http://dx.doi.org/10.21608/dusj.2022.275422.

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30

Laurén, Anna, Manuela Braun, Paul Byrne, et al. "Applying context of use to quantitative polymerase chain reaction method validation and analysis: a recommendation from the European Bioanalysis Forum." Bioanalysis 13, no. 23 (2021): 1723–29. http://dx.doi.org/10.4155/bio-2021-0218.

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Polymerase chain reaction (PCR) is widely used in various fields of laboratory testing, ranging from forensic, molecular biology, medical and diagnostic applications to a wide array of basic research purposes. COVID-19 infection testing has brought the three-letter PCR abbreviation into the vocabulary of billions of people, making it likely the most well-known laboratory test worldwide. With new modalities and translational medicine gaining importance in pharmaceutical research and development, PCR or more specifically, quantitative PCR (qPCR) is now becoming a standard tool in the (regulated)

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31

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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32

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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33

Iram, Farah, Huma Iram, Mohd Arif, A. A. Siddiqui, and Asif Husain. "Bioanalytical Method Development and Validation by Hyphenated Technique (LC-MS/MS)." Journal of Pharmaceutical and Medicinal Chemistry 2, no. 1 (2016): 11–26. http://dx.doi.org/10.21088/jpmc.2395.6615.2116.2.

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34

Li, Ming, Judy Chou, Kristopher W. King, and Liyu Yang. "Small-molecule bioanalytical sample preparation method development starting from the BASICS." Bioanalysis 7, no. 18 (2015): 2331–43. http://dx.doi.org/10.4155/bio.15.132.

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35

Sapna, Pandey A., and Monika P. Jadhao. "Bioanalytical Method Development and Validation of Antihelmintic Drug in Human Plasma." Asian Journal of Pharmaceutical Research and Development 12, no. 3 (2024): 169–75. http://dx.doi.org/10.22270/ajprd.v11i3.1414.

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Triclabendazole is an anthelmintic or anti-worm medication. Asimple and sensitive bio-analytical HPLC method with UV detection was developed and validated triclabendazole in human plasma. The analytes were extracted from human plasma samples by liquid-liquid extraction technique. Triclabendazole showed maximum absorbance i.e.; λmax at 305 nm. The developed analytical method was validated as per ICH guidelines. The chromatographic separation was achieved with Hypersil BDS C18 (250 mm x 4.6 mm, Particle size: 5 µm), software Autochrom 3000 using a mobile phase composition of acetonitrile and buf

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36

Srivastava, Gaurav. "Bioanalytical Method Development, Validation and Oral Pharmacokinetic Profile of Chebulinic Acid." African Journal of Biological Sciences 6, Si3 (2024): 2642–52. http://dx.doi.org/10.48047/afjbs.6.si3.2024.2642-2652.

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Terminalia chebula Retz, sometimes referred to as "Haritaki/Myrobalan," has long been used in traditional medicine. It has been widely used in many traditional medical systems, including Unani, Tibb, Ayurveda, and Siddha, to treat a wide range of conditions in people, including bleeding, diarrhoea, carminatives, liver tonics, digestive problems, antidiarrheal, analgesics, anthelmintics, antibacterials, and skin disorders. Using a variety of computerized databases, research on the pharmacological effects of T.

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37

Sheu, Ming-Thau, An-Bang Wu, Geng-Cheng Yeh, Angel Hsia, and Hsiu-O. Ho. "Development of a liquid chromatographic method for bioanalytical applications with sildenafil." Journal of Chromatography B 791, no. 1-2 (2003): 255–62. http://dx.doi.org/10.1016/s1570-0232(03)00223-x.

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38

Muralidharan, Selvadurai, Vijayan Venugopal, Jayaraja Kumar, Joshua Ho Chen Chiang, Julin Bee Chu Chin, and Siew Chiu Ghan. "Bioanalytical Method Development and Validation of Griseofulvin Nanoparticles using RP-HPLC." Journal of Young Pharmacists 7, no. 4 (2015): 384–98. http://dx.doi.org/10.5530/jyp.2015.4.13.

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Muralidharan, Selvadurai, Jayarajakumar Kalaimani, Subramani Parasuraman, and Sokkalingam Arumugam Dhanaraj. "Development and Validation of Acyclovir HPLC External Standard Method in Human Plasma: Application to Pharmacokinetic Studies." Advances in Pharmaceutics 2014 (December 31, 2014): 1–5. http://dx.doi.org/10.1155/2014/284652.

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A simple, rapid, and selective RP-HPLC method was developed for the estimation of acyclovir in human plasma. The method involves a simple protein precipitation technique. Chromatographic separation was carried out on a reverse phase C18 column using mixture of 5 mM ammonium acetate (pH 4.0) and acetonitrile (40 : 60, v/v) at a flow rate of 1.0 mL/min with UV detection at 290 nm. The retention time of acyclovir was 4.12 minutes. The method was validated and found to be linear in the range of 25.0–150.0 ng/mL. Validation studies were achieved by using the fundamental parameters, including accura

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40

More, Shravani S., Sandhya P. Kadam, and Dr Vivekkumar K.Redasani. "A Review on Analytical Method Development And Validation." International Journal of Pharmaceutical Research and Applications 10, no. 1 (2025): 1177–95. https://doi.org/10.35629/4494-100111771195.

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Analytical method development and validation are essential components in pharmaceutical, chemical, and biological research, ensuring accurate, reliable, and reproducible data for quality assessment and regulatory compliance. Method development involves selecting and optimizing analytical techniques to achieve accurate detection and quantification of target compounds under specific conditions. Validation establishes that the method meets critical parameters such as accuracy, precision, specificity, linearity, sensitivity, robustness, and reproducibility. These processes ensure compliance with i

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41

Karan, Wadhwa, and Rana A.C. "Development and validation of HPLC-UV based bioanalytical method for the quantification of atorvastatin in rat plasma." World Journal of Advanced Research and Reviews 7, no. 3 (2020): 121–32. https://doi.org/10.5281/zenodo.4317628.

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A highly selective, sensitive, and fast HPLC based bioanalytical method was developed and validated for the estimation of atorvastatin in rat plasma which can be further employed in pharmacokinetic studies. The developed analytical procedure utilized protein precipitation approach to extract atorvastatin from rat plasma using ice-cold acetonitrile as an extraction solvent and diclofenac as IS. The chromatographic separation of atorvastatin was achieved on a LiChrospher RP C-18 column (250 × 4.6 mm, 5 μm) using isocratic elution of  Methanol: water (containing 0.05 % glacial aceti

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42

Ashutosh, Badola, Joshi Preeti, and Kothiyal Preeti. "A General Review on Bioanalytical Method Development and Validation for LC MS MS." International Journal of Trend in Scientific Research and Development 2, no. 4 (2018): 1340–47. https://doi.org/10.31142/ijtsrd14203.

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Rapid growth in the use of LC MS MS for the analysis of drugs in biological matrices has been compelled by the need for timely and high quality data at every stages in drug discovery and development process from throughput screening of drug candidates and rapid data generation for pre clinical studies to almost real time analysis of clinical samples. A well developed bioanalytical development and its validation plays a pivotal role in achieving the goals. . The aim behind this review is to enlighten the need of validation which provide a practical approach for determining the different paramet

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43

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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44

Koster, Remco A. "Have we got ‘patient-centric sampling’ right?" Bioanalysis 12, no. 13 (2020): 869–72. http://dx.doi.org/10.4155/bio-2020-0146.

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RA Koster currently works as Associate Director of Bioanalytical Science at the LC–MS/MS department at PRA Health Sciences in the Laboratory in Assen, The Netherlands. He is responsible for the LC–MS/MS analytical method development and leads a team of method development analysts and scientists. As global microsampling specialist within PRA he is interested in all developments regarding microsampling and aims to continuously improve microsampling techniques. He has been working in the field of bioanalysis for 19 years, in which he performed and supervised numerous analytical method development

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45

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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Petrov, V. I., I. S. Anikeev, T. E. Zayachnikova, A. V. Strygin, A. M. Dotsenko, and A. O. Strygina. "DEVELOPMENT AND VALIDATION OF A QUANTITATIVE HPLC/MS/MS METHOD FOR THE DETERMINATION OF VANCOMYCIN IN BLOOD PLASMA." Journal of Volgograd State Medical University 19, no. 4 (2022): 128–34. http://dx.doi.org/10.19163/1994-9480-2022-19-4-128-134.

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Within the framework of this study, a quantitative HPLC-MS/MS (high-performance liquid chromatography with mass spectrometric detection) method for the determination of vancomycin was developed. The method for the quantitative determination of vancomycin in human plasma was validated using the chromato-mass spectrometric method. The method was validated in accordance with the requirements of the EAEU for bioanalytical methods. The validated analytical range of the technique was 1-100 pg/mL in plasma.

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Farooq, Jagirdar Sikandar Zoolquernain, and Furquan Nazimuddin Khan. "QbD-Driven Development and Validation of a Bioanalytical LC–MS Method for Quantification of Paliperidone in Human Plasma." International Journal of Experimental Research and Review 36 (December 30, 2023): 47–57. http://dx.doi.org/10.52756/ijerr.2023.v36.004.

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This paper discusses how a Quality by Design (QbD) strategy was used to develop and test an HPLC-MS bioanalytical method for detecting plasma Paliperidone concentration. A C18 column and an isocratic mobile phase of organic solvents and water were improved for chromatographic separation. To optimise method performance, Box-Behnken design was used to study column temperature, mobile phase composition, and flow rate. The research used a logical QbD methodology to build an optimised HPLC-MS technology that meets US-FDA standards. Validation studies evaluated selectivity, sensitivity, carryover ef

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Patel, Bhavesh D., Ritika Uppal, Nageswararao Pulakundam, et al. "Development and validation of LC–MS/MS method for determination of DNDI-VL-2098 in mouse, rat, dog and hamster blood." Bioanalysis 11, no. 15 (2019): 1419–35. http://dx.doi.org/10.4155/bio-2019-0128.

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Aim: To develop a bioanalytical method to support pharmacokinetic evaluation of DNDI-VL-2098 in mouse, rat, dog and hamster following oral administration. Results & methodology: A robust LC–MS/MS bioanalytical method was developed to quantify DNDI-VL-2098. DNDI-VL-2098 showed time-dependent recovery loss in acetonitrile precipitated plasma in all species. Acid-lysed whole blood was identified as a matrix in which recovery was stable over time. A two-step extraction procedure was used, with protein precipitation followed by liquid–liquid extraction with methyl tert-butyl ether. The assay wa

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Prajapati, Malesh, Dilip Bhagwan Yamgar, Mayur Narayan Desale, and Bharti Fegade. "A Review on Various Analytical Methodologies for Etoricoxib." Advanced Journal of Graduate Research 11, no. 1 (2021): 61–70. http://dx.doi.org/10.21467/ajgr.11.1.61-70.

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Etoricoxib belongs to the class of highly selective COX-2 inhibitor NSAIDs. It is mostly used for the treatment of pain, arthritic conditions including rheumatoid arthritis and osteoarthritis. The current study focuses primarily on analytical and bioanalytical method development methodologies, as well as numerous methods established for the estimation of etoricoxib, whether in pharmaceutical dose form or in bulk. Analytical procedures are critical for determining compositions, as they allow us to obtain both qualitative and quantitative results utilising advanced analytical tools. The analytic

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L. Pithiya, Gaurang, Nilesh K. Patel, Ashok B. Patel, Amit J. Vyas, and Ajay Patel. "A Review on Bioanalytical Method Development and Validation by LC-MS/MS." Journal of Pharmaceutical and Medicinal Chemistry 2, no. 1 (2016): 95–101. http://dx.doi.org/10.21088/jpmc.2395.6615.2116.9.

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