Publication / Source: Bioanalysis 3(10)
Authors: Barrientos-Astigarraga ER
“Regulatory agencies in Latin America are trying to amend their guidelines to the international standard. In the near future, most of the countries will adopt specific requirements for generic medicines and this fact will allow the bioanalysis community in this region to expand.”
Bioanalysis (BA) has experienced very fast growth in Latin America (LATAM). The first BA guidelines were implemented in the region in 1998, starting in Mexico and Brazil. More than 12 years later, Brazil is leading the BA market, both in number of assays and regarding the technology used. Market size as well as governmental policies for generic drugs can explain this. Most of the BA laboratories in Brazil currently use LC–MS/MS as the most common analytical technique. Mexico has decided to close its BA market to foreign bioanalytical CROs before such ‘restraint of trade’ occurs. Other countries such as Argentina, Chile and Uruguay are also trying to establish bioanalytical laboratories. In most LATAM countries, BA is mostly related to the analysis of small molecules in biological samples for bioequivalence studies.