Wide Spread use of LC-MS in Bioequivalence Studies

Abstract

Submit Manuscript | http://medcraveonline.com FDA guidance on analytical method validation, in one form or another, has been adopted universally as a standard procedure for validating bioanalytical assays used for pharmcokinetic, bioavailability, and bioequivalence studies intended for regulatory submission [2]. Before the first bioanalytical method validation workshop, there was lack of uniformity in conducting validation of bioanalytical methods and submission of data to regulatory agencies. The bioanalytical validation workshop in 1990 was the first major workshop dedicated to investigating and harmonizing procedures in method validation. The workshop was cosponsored by the American Association of Pharmaceutical Scientists (AAPS), the US FDA, the International Pharmaceutical Federation (FIP), the Health Protection Branch (HPB), and the Association of Analytical Chemists (AOAC). The conference focused on the requirements for bioanalytical method validation procedures to establish reliability of the analytical method, parameters to ensure acceptability of analytical method performance, method development (prestudy validation), and method application (instudy validation). The workshop defined important parameters for method validation e.g. accuracy, precision, selectivity, sensitivity, reproducibility, limit of quantification as well as addressing “how to” evaluate and determine these parameters. It was also clarified that it is not essential to have 100% recovery, but it is important that the recovery be reproducible. One of the most important outcomes of the first workshop was that it defined “the acceptance criteria for a run”. The recommendations of the first workshop were well received within the scientific community. These recommendations did not become did not become official until the draft guidance on bioanalytical method validation was published in January 1999 by the US FDA with the intention of seeking public opinion prior to finalizing the guidance. The second bioanalytical method validation workshop was cosponsored by the AAPS and the US FDA in January 2000 a year after the draft guidance went into effect and ten years after the first workshop took place. The main advances occurred in the field of mass spectrometry. Two issues were addressed in relation to LC-MS;