International Guidelines for Bioanalytical Method Validation: A Comparison and Discussion on Current Scenario |
| |
Authors: | Sivacharan Kollipara Girish Bende Nitin Agarwal Brijesh Varshney Jyoti Paliwal |
| |
Institution: | 1. Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, Gurgaon, Haryana, 122015, India 2. Formulation Development and Pharmacokinetics Laboratory, Pharmacy Group, Birla Institute of Technology and Science, Pilani, Rajasthan, 333031, India
|
| |
Abstract: | US FDA released guidelines for bioanalytical method validation in 2001 and it became the basis for guidelines such as ANVISA and EMA. Even though there is a general agreement between these guidelines in terms of evaluation of validation parameters, significant diversity exists with respect to methodology employed. Present review compares and summarizes the regulatory guidelines issued by US FDA, ANVISA and EMA for bioanalytical method validation. This review also discusses evaluation of certain validation parameters such as matrix effect, incurred sample reanalysis, various stability aspects, effect of anticoagulant counter ions, specificity in the presence of concomitant medications, and identification of pharmacokinetic repeats wherein specific guidance and general consensus amongst scientific community does not exist. |
| |
Keywords: | |
本文献已被 SpringerLink 等数据库收录! |
|