Bioanalytical Method Validation and Its Pharmaceutical Application- AReview (original) (raw)
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journal of applied pharmaceutical science, 2023
The bioanalytical method certifications (validation) are very essential for therapeutic drug monitoring. It is critical to use well-defined and completely validated procedures to provide reliable results which can be properly interpreted. This review provides practical steps and procedures with bioanalytical methods validation and highlights chromatographic method validations that have been used in the bioanalysis. It also attempts to clarify the nomenclature of certain stages of bioanalytical validation and to describe the overall process used for the drugs measurement and their metabolites in biological matrices and fluids. The stages of this procedure are discussed and correlated with data of scientific literature. A consistent description of key bioanalytical parameters is discussed and investigated with a view to improve scientific standards of bioanalytical methods used in clinical studies.
Bioanalytical method validation: An updated review
Pharmaceutical Methods, 2010
The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development, culminating in a marketing approval. The objective of this paper is to review the sample preparation of drug in biological matrix and to provide practical approaches for determining selectivity, specifi city, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness of liquid chromatographic methods to support pharmacokinetic (PK), toxicokinetic, bioavailability, and bioequivalence studies. Bioanalysis, employed for the quantitative determination of drugs and their metabolites in biological fl uids, plays a signifi cant role in the evaluation and interpretation of bioequivalence, PK, and toxicokinetic studies. Selective and sensitive analytical methods for quantitative evaluation of drugs and their metabolites are critical for the successful conduct of pre-clinical and/or biopharmaceutics and clinical pharmacology studies.
A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION
In this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should be applied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and their metabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigated to decide the extent to which environment, matrix, or procedural variables can interfere the estimation of analyte in the matrix from the time of set up to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double mass spectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographic methods are HPLC and gas chromatography have been mainly used for the bioanlysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy, precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposed to add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug, concentration and its metabolite.
Bio-Analytical Method Validation-A Review
Austin Journal of Analytical and Pharmaceutical Chemistry, 2015
Validation is a basic requirement to ensure quality and reliability of method development in analytical and bio-analytical process. Bio-analytical method development is very important during the process of drug discovery and development for marketing approval. The purpose of this review is to discuss about the step involved in validation and provide a practical approach for determining the different parameters like selectivity, specifity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness to help the perfect studies of pharmacokinetic, toxic kinetic, bioavailability and bioequivalence. Bio-analysis study is for the quantitative determination of drug and their metabolites in biological fluids. Accurate and robust methods for quantitative analysis of drug and their metabolites are important for the successful conduct of pre-clinical, bio-pharmaceutics and clinical pharmacology.
A Comprehensive Review on Bioanalytical Method Development and Validation for Pharmaceuticals
International Journal of Pharmaceutical Sciences Review and Research, 2022
Bioanalysis is most widely used for drug discovery and development. Bioanalytical methods have been working for the quantitative estimation of drugs, or its metabolites and biomarkers in its biological samples. The steps involved in bioanalysis comprise of many steps that are from sample collection to sample analysis and then data reporting. The first step involves sample collection from clinical or preclinical studies. After that, the analysis of the sample is done in the laboratory. The second step involves the sample cleanup the cleanup process should be carried out carefully to eliminate the interferences present in the sample matrix. And it increases the performance of the analytical system. The last step involves sample analysis and detection of a separated compound and detection techniques used are HPLC and Liquid chromatography coupled with double mass spectrometry (LCMS-MS) and are used in the bioanalysis of drugs in the body. Each one of these has its advantage and disadvantage. For bioanalysis of small or large molecules, the Chromatographic methods used are HPLC, and Gas Chromatography with LC/MS/MS. The review focuses on an overview of the bioanalytical method, development, validation, and the quality of sample preparations.
Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry
Journal of Pharmaceutical and Biomedical Analysis, 2016
Various bioanalytical method validation guidelines have been issued worldwide by different regulatory agencies. This review provides summary to evaluate the different guidelines during bioanalytical method development and validation. Different evaluation parameters such as matrix effect, incurred sample reanalysis and various stability aspects with an easy way for designing the bioanalytical method validation have been discussed.
Bioanalytical Method Validation—A Revisit with a Decade of Progress
Pharmaceutical Research, 2000
January 12-14, 2000), sponsored by the American Association of Pharmaceutical Scientists and the U. S. Food and Drug Administration. The bioanalytical method validation workshop of January 12-14, 2000 was directed towards small molecules. A separate workshop was held in March 1-3, 2000 to discuss validation principles for macromolecules. The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop. The report is also intended to provide guiding principles for validation of bioanalytical methods employed in support of bioavailability, bioequivalence, and pharmacokinetic studies in man and in animals.
Bioanalytical Method Development and Validation: A Review
Recent Advances in Analytical Chemistry, 2019
For various types of drug approval processes like INDs, NDAs, ANDAs, veterinary drug approval, the data related to bioanalytical method development and validation is needed to sponsors. Various agencies namely US FDA, American association of pharmaceutical scientists (AAPS), Health protection Branch (HPB), Association of analytical chemists (AOAC), Center for Veterinary Medicine (CVM), U.S. Department of Health and Human Services Food and drug Administration, Center for Drug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug administration(CFDA), European Bioanalytical Forum (EBF), Global CRO council (GCC), ANVISA (Brazil), Japan Bioanalytical Forum (JBF) had done collective efforts at different timings to regulate and harmonize bioanalytical method development and validation. Regulatory guidance documents are available as a result of the involvement of various official agencies. Bioanalytical method development and validation can be performed with v...
A Comparative Review on Bioanalytical Method Validation as Per Various Regulatory Guidelines
2019
1. Assistant Professor, Department of Quality Assurance, Smt. S. M. Shah Pharmacy College, Mahemdavad, Gujarat, India 2. Student of M.Pharm, Department of Quality Assurance, Smt. S. M. Shah Pharmacy College, Mahemdavad, Gujarat, India 3. Head of Department, Department of Quality Assurance, Smt. S. M. Shah Pharmacy College, Mahemdavad, Gujarat, India 4. Assistant Professor, Department of Pharmaceutics, Smt. S. M. Shah Pharmacy College, Mahemdavad, Gujarat, India
Journal of Pharmaceutical and Biomedical Analysis, 2003
The Société Française des Sciences et Techniques Pharmaceutiques (SFSTP) published in 1997 a guide on the validation of chromatographic bio-analytical methods, which introduces new concepts in three different areas: stages of the validation, test of acceptability of a method and design of experiments to perform. In 'stages of validation', the SFSTP guide requires two phases to validate a method. The first phase, called 'prevalidation', is intended to (1) identify the model to use for the calibration curve; (2) evaluate the limits of quantitation; and (3) provide good estimates of the precision and bias of the method before designing the 'validation' phase per se. In the 'test of acceptability', the use of the interval hypotheses is envisaged by the SFSTP guide, not on the parameters of bias and precision, but on individual results by mixing mean bias and intermediate precision in a single test. The SFSTP guide also avoids the use of Satterthwaite's df for testing the acceptability. The reasons for those choices are discussed extensively. In 'design of experiments', much effort has been devoted to improving the quality of results by optimally designing and sizing the experiments to perform in validation. The rationale for using near D-optimal designs for the calibration curve is demonstrated and sample sizes are proposed to correctly size the validation experiments. #