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Journal articles on the topic 'Bioanalytical method validation'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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1

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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3

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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5

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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6

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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7

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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9

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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11

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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12

Shah, Vinod P. "The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation." AAPS Journal 9, no. 1 (2007): E43—E47. http://dx.doi.org/10.1208/aapsj0901005.

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13

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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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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15

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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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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17

James, C. A., M. Breda, and E. Frigerio. "Bioanalytical method validation: a risk-based approach?" Journal of Pharmaceutical and Biomedical Analysis 35, no. 4 (2004): 887–93. http://dx.doi.org/10.1016/j.jpba.2004.02.028.

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18

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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19

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

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

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20

Hougton, Richard, Dominique Gouty, John Allinson, et al. "Recommendations on biomarker bioanalytical method validation by GCC." Bioanalysis 4, no. 20 (2012): 2439–46. http://dx.doi.org/10.4155/bio.12.197.

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21

Kelley, Marian, and Binodh DeSilva. "Key elements of bioanalytical method validation for macromolecules." AAPS Journal 9, no. 2 (2007): E156—E163. http://dx.doi.org/10.1208/aapsj0902017.

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22

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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23

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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24

Kaza, M., M. Karaźniewicz-Łada, K. Kosicka, A. Siemiątkowska, and P.J. Rudzki. "Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?" Journal of Pharmaceutical and Biomedical Analysis 165 (December 19, 2018): 381–85. https://doi.org/10.1016/j.jpba.2018.12.030.

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Bioanalysis concerns the identification and quantification of analytes in various biological matrices. Validation of any analytical method helps to achieve reliable results that are necessary for proper decisions on drug dosing and patient safety. In the case of bioanalytical methods, validation additionally covers steps of pharmacokinetic and toxicological studies – such as sample collection, handling, shipment, storage, and preparation. We drew our attention to the difference of both the newest FDA Guidance and the EMA Guideline on bioanalytical method validation. We aimed to point out

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25

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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26

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

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

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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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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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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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Bansal, Surendra, and Anthony DeStefano. "Key elements of bioanalytical method validation for small molecules." AAPS Journal 9, no. 1 (2007): E109—E114. http://dx.doi.org/10.1208/aapsj0901011.

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31

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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32

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

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

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33

Erdoğar, Nazlı, Tuba Reçber, Alper B. İskit, Erem Bilensoy, Sedef Kır, and Emirhan Nemutlu. "Determination and validation of aprepitant in rat plasma using LC−MS/MS." Bioanalysis 13, no. 5 (2021): 363–72. http://dx.doi.org/10.4155/bio-2020-0293.

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Aim: The assessment of efficacy should be paralleled with extensive pharmacokinetic parameters, and a valid bioanalytical method is a pre-condition for accurate plasma concentration. Materials & methods: A simple, specific, rapid and sensitive LC−MS/MS method has been developed for quantitative analysis of aprepitant in rat plasma. A C18 column was used as stationary phase and the mobile phase consisted of a mixture of formic acid in water and formic acid in acetonitrile. Quantification was performed using multiple reaction monitoring mode. Results: The selectivity, linearity, accuracy, pr

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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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Chadha, Renu, Alka Bali, and Gulshan Bansal. "Bioanalytical Method Validation for Dronedarone and Duloxetine in Blood Serum." Journal of AOAC INTERNATIONAL 100, no. 1 (2017): 45–50. http://dx.doi.org/10.5740/jaoacint.16-0204.

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Abstract The present work relates to the development and validation of reversed-phase HPLC–UV-photodiode array methods for the estimation of two drugs in blood serum: dronedarone hydrochloride (DDN), a class III antiarrhythmic drug, and duloxetine hydrochloride (DLX), an antidepressant. Chromatographic analysis of DLX was carried out on a Nucleodur C18 column (250 × 4.6 mm, 5 μm) using ammonium acetate buffer (32 mM, pH 5.5) and acetonitrile (40 + 60, v/v; flow rate of 1.0 mL/min; detection wavelength of 290 nm) as the mobile phase. A Waters XTerra C18 column (250 × 4.6 mm, 5 μm) was used for

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36

Lowes, Stephen, and Michael Brown. "Bioanalytical method validation guidance language and a decade of progress." Bioanalysis 11, no. 7 (2019): 587–93. http://dx.doi.org/10.4155/bio-2019-0051.

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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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Kadian, Naveen, Kanumuri Siva Rama Raju, Mamunur Rashid, Mohd Yaseen Malik, Isha Taneja, and Muhammad Wahajuddin. "Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry." Journal of Pharmaceutical and Biomedical Analysis 126 (July 2016): 83–97. http://dx.doi.org/10.1016/j.jpba.2016.03.052.

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Arnold, Mark E., Brian Booth, Lindsay King, and Chad Ray. "Workshop Report: Crystal City VI—Bioanalytical Method Validation for Biomarkers." AAPS Journal 18, no. 6 (2016): 1366–72. http://dx.doi.org/10.1208/s12248-016-9946-6.

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40

Smolec, JoMarie, Binodh DeSilva, Wendell Smith, et al. "Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies." Pharmaceutical Research 22, no. 9 (2005): 1425–31. http://dx.doi.org/10.1007/s11095-005-5917-9.

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41

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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42

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

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

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43

Timmerman, Philip, Joanne Goodman, Michaela Golob, et al. "European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period." Bioanalysis 12, no. 6s (2020): 1–11. http://dx.doi.org/10.4155/bio-2020-0065.

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Once released, the ICH M10 Guideline on bioanalytical method validation will become one of the most important milestones in the history of regulated bioanalysis, closing a chapter on intense discussions among the industry and health authorities started in Crystal City in 2001. In this manuscript, the European Bioanalysis Forum community reports back on their feedback on the ICH M10 draft guideline gathered during the public consultation period. The comments given are intended to contribute to a guideline that combines several decades of experience and current scientific vision. They should pro

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Ramanathan, Lakshmi, and Helen Shen. "LC–TOF–MS methods to quantify siRNAs and major metabolite in plasma, urine and tissues." Bioanalysis 11, no. 21 (2019): 1983–92. http://dx.doi.org/10.4155/bio-2019-0134.

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There are a few different bioanalytical approaches that have been used for the quantification of siRNA in biological matrices, such as S1 nuclease protection ‘cutting ELISA’, fluorescent probe hybridization HPLC, HPLC UV, LC–MS/high-resolution accurate-mass (HRAM) and LC–MS/MS. We have developed and validated plasma assays for several oligonucleotides such as GalNAc-conjugated siRNA, using uHPLC and high-resolution mass spectrometer by TOF detection. Although the molecular weights are in the range of 7000–9000, we were able to meet the same assay acceptance criteria as for the small molecules

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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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Boridy, Sebastien, and Kuiyi Xing. "Assessing the long-term stability of anti-drug antibodies in method validation: what is the added value?" Bioanalysis 11, no. 20 (2019): 1899–903. http://dx.doi.org/10.4155/bio-2019-0185.

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The stability of analytes in biological matrices is a critical parameter assessed under bioanalytical method validations. Assessing the stability of anti-drug antibodies (ADA) is, however, not evident given the polyclonal antibody response and the practicality of obtaining reference material from human subjects. Moreover, the same argument that different test articles exhibit different stabilities does not translate to polyclonal antibodies, for which there is a body of literature supporting the stability of human antibodies in undiluted human biological matrix for several years. Herein, the c

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Brodie, R. R., and H. M. Hill. "Validation issues arising from the new FDA guidance for industry on bioanalytical method validation." Chromatographia 55, S1 (2002): S91—S94. http://dx.doi.org/10.1007/bf02493361.

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

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

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

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

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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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