Abstract
Bioanalytical method development is the process of creating a procedure to enable a compound of interest to be identified and quantified in a biological matrix. A compound can often be measured by several methods and the choice of analytical method involves many considerations. Analysis of drugs and their metabolites in a biological matrix is carried out using different extraction techniques like liquid-liquid extraction, solid phase extraction (SPE) and protein precipitation from these extraction methods samples are spiked with calibration (reference) standards and using quality control (QC) samples. These methods and choice of analytical method describes the process of method development and includes sampling, sample preparation, separation, detection and evaluation of the results. The developed process is then validated. These Bioanalytical validations play a significant role in evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic studies. In which different parameters like accuracy, precision, selectivity, sensitivity, reproducibility, and stability are performed.
 Keywords: - LLE, SPE, Quality control samples, Bioequivalence, Bioavailability, Validation.
Highlights
BIO-ANALYTICAL METHOD The methods employed for detection and measurement of drug concentrations in biological fluids are referred to as Bio-Analytical Methods
Bioanalytical method development is the process of creating a procedure to enable a compound of interest to be identified and quantified in a biological matrix
Analysis of drugs and their metabolites in a biological matrix is carried out using different extraction techniques like liquid-liquid extraction, solid phase extraction (SPE) and protein precipitation from these extraction methods samples are spiked with calibration standards and using quality control (QC) samples
Summary
BIO-ANALYTICAL METHOD The methods employed for detection and measurement of drug concentrations in biological fluids are referred to as Bio-Analytical Methods. Bio-analytical methods are widely used to quantitate drugs and their metabolites in physiological matrices. To investigate the pharmacokinetic of new drug candidates. 2. To compare pharmacokinetic profiles of different formulations. 3. To monitor drug levels to establish the appropriate dose or frequency of administration. 4. For fast and reliable measurement of the compounds in biological matrices. 5. A bio-analytical method consists of two main components: - Sample Preparation - Determination of drug and its metabolites. 1. Peak Plasma Concentration (Cmax): In Cmax, maximum concentration of analyte in biological fluid to be determined from literature survey, which is helps in establishment of target sensitivity of the developing method
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