European Journal of Biomedical and Pharmaceutical Sciences

A COMPARISON AND DISCUSSION OF INTERNATIONAL GUIDELINES FOR BIOANALYTICAL METHOD VALIDATION

Namrata Gulab Goswami*, Bhumika J. Gohil, Divyangini H. Tandel, Mr. Ajay N. Talele, Dr. Sachin B. Narkhede

ABSTRACT

US FDA guideline comes into effect in 2001 for Bioanalytical Method Validation that Provide Guidance for Industry. This guidance is adopted universally by all over Pharma Industries and contract research industries as standard approach for conducting validation and for implementing bio-analytical methods that are used to obtain data to support medical applications. ANVISA and EMA get developed on the basis of US FDA. General agreement is there between this guideline to evaluate the different validation parameters based on which methodology is employed. This review compares regulatory guidelines by US FDA, ANVISA and EMA and summarizes it for bioanalytical method validation. Present review include discussion on evaluation of several validation parameters those are specificity, calibration curve/linearity, sensitivity, accuracy, precision, recovery various stability analysis.

Keywords: Bioanalysis, Validation, US FDA, ANVISA, EMA, Regulatory guidance.