Search

At the request of French Regulatory Authorities, a new formulation of Levothyrox® was licensed in France in 2017, with the objective of avoiding the stability deficiencies of an existing licensed formulation. Before launching the new formulation, an average bioequivalence (ABE) trial was conducted, having enrolled 204 subjects and selected for interpretation a narrow a priori bioequivalence range of 0.90-1.11. Bioequivalence was concluded. In a previous publication, we questioned the ability of an ABE trial to guarantee the switchability within patients of the new and old levothyroxine formulations. It was suggested that the two formulations should be compared using the conceptual framework of individual bioequivalence. The present paper is a response to those claiming that, despite the fact that ABE analysis does not formally address the switchability of the two formulations, future patients will nevertheless be fully protected. The basis for this claim is that the ABE study was established in a large trial and analyzed using a stringent a priori acceptance interval of equivalence. These claims are questionable, because the use of a very large number of subjects nullifies the implicit precautionary intention of the European guideline when, for a Narrow Therapeutic Index drug, it recommends shortening the a priori acceptance interval from 0.80-1.25 to 0.90-1.11. [ABSTRACT FROM AUTHOR]

While cognitive sociology is a relatively new area in U.S. sociology, the subfield has a lengthy history in French sociology. Developing a typology based upon the existing literature, we identify three branches of cognitive sociology in France. The first was initiated by Raymond Boudon, one of the scholars most responsible for popularizing the area, who envisioned cognitive sociology as helping delineate the role of beliefs in rational action. Second, another group of researchers seeks to found sociology upon a naturalistic basis, thus drawing upon the disciplines constitutive of cognitive science (e.g., psychology, cognitive neuroscience, and cognitive anthropology). Finally, the third approach to cognitive sociology in France takes inspiration from linguistics as a foundation for sociological investigations. We conclude the paper by discussing the relationship between these three sub-fields and by examining the relationship between French and American cognitive sociologies in order to identify fruitful directions for future research. [ABSTRACT FROM AUTHOR]