A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION AND STEPS FOR BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION
Gohil Bhumika Jayeshsinh*, Namrata G. Goswami, Divyangini H. Tandel, Dr. Chirag Desai and Dr. Sachin B. Narkhede
ABSTRACT
A Bioanalytical method meansthe quantitative and qualitative analysis of drugs in biological matrices. Bioanalytical method should be useful to studies in area of human clinical and non-clinical study. Bioanalytical method plays an important role in estimation and analysis of bioavailability-bioequivalence, pharmacokinetic and toxicokinetic studies. A Bioanalytical method has three essential Component method development, method validation and sample analysis. Every step in the method must be studied to decide which Environment, matrix or procedural variable can interfere with the estimation of analyte in the matrix from the time of set up to time of analysis. various steps for development of bioanalytical method. Linearity, accuracy, precision, selectivity, sensitivity, reproducibility, Matrix effect, dilution integrity and stability are some of the Validation parameters. In this present review article includes some points regarding Introduction on bioanalytical method development and method validation, steps for how to method develop, Beneficial to Quality assurance to determine safety and efficacy of drug and its metabolites.
Keywords: Step for bioanalysis, How to method develop, Bioanalyticaltechniques (PPT, LLE, SPE), Estimation of drug in biological matrix.
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