**5. Bioanalytical method development and validation**

There were various regulatory agencies had done serious efforts to regulate bioanalytical method development and validation. Almost from last three decades there were large progresses in this area. The various regulatory agencies that were worked can be listed as US FDA, American association of pharmaceutical scientists (AAPS), Health protection Branch HPB, Association of analytical chemists (AOAC), Center for Veterinary medicine (CVM), U. S. Department of Health and Human Services Food and drug Administration, Center for Drug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug Administration (CFDA), European Bioanalytical forum (EBF), Global CRO Council (GCC), The Brazilian health regulatory agency (ANVISA, Brazil). To regulate and harmonize bioanalytical method development and validation first workshop was held in 3–5 December 1990, report of which was published in pharmaceutical research and in other journals. On basis of the reports of this workshop, the FDA was issued draft guidance on bioanalytical method development and validation in January 1999.The second FDA guidance was published in May 2001 on the basis of workshop which was held in January 2000.The recommendations for bioanalytical method development and validation for macromolecules was published in 2006. The recommendations for regulation and harmonization of bioanalytical methods were again refreshed in 2006. In 2010, a draft guidance was published by EMA for development and validation of bioanalytical methods. As per above discussion this can be concluded that there were serious efforts carried out to regulate bioanalytical method development and validation by the various abovementioned regulatory agencies.
