BIOANALYTICAL METHOD VALIDATION- A REVIEW

BIOANALYTICAL METHOD VALIDATION- A REVIEW
Author(s):
Dr Vamseekrishna G, Salman Khan, Paidipamula Tarun kumar, Podila Sai Teja, Sarnala Mahendra, Vankayala Vasu, S V Kali Dinesh, Dr I V Rama Rao
Keywords:
Bioanalytical method validation , Biological matrix, Bioavailability, Bioequivalence
Abstract
Bioanalytical method development is the process of preparing a procedure to know a compound of interest to be identified and quantified in a biological matrix. A compound can be examined 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. 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 pivotal role in evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic studies and different parameters like accuracy, precision, selectivity, sensitivity, reproducibility, and stability are performed.
Article Details
Unique Paper ID: 161339 Publication Volume & Issue: Volume 10, Issue 3 Page(s): 445 - 455
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