Bioanalysis of antitubercular drugs using liquid chromatography.

Tuberculosis is a life threatening disease and second to HIV in terms of deaths due to infectious diseases. Drug resistance development of the first-line drugs is a major concern in the treatment of this disease. There is no comprehensive and critical review in the literature of the bioanalytical methods for the determination of anti-tubercular agents from last two decades.

Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry.

The concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. United States Food and Drug Administration (USFDA) guidelines issued in 2001 have been referred for every guideline released ever since; may it be European Medical Agency (EMA) Europe, National Health Surveillance Agency (ANVISA) Brazil, Ministry of Health and Labour Welfare (MHLW) Japan or any other guideline in reference to bioanalytical method validation. After 12 years, USFDA released its new draft guideline for comments in 2013, which covers the latest parameters or topics encountered in bioanalytical method validation and approached towards the harmonization of bioanalytical method validation across the globe.