Current regulatory guidances do not address specific study designs for in vitro and in vivo
drug‐drug interaction studies. There is a common desire by regulatory authorities and by …

Current regulatory guidances do not address specific study designs for in vitro and in vivo
drug-drug interaction studies. There is a common desire by regulatory authorities and by …

Purpose. Highly variable drugs pose a problem in bioequivalence assessment because
they often fail to meet current regulatory acceptance criteria for average bioequivalence (80–125…

Various approaches are compared for the design and analysis of studies to assess the transfer
of an analytical method from a research and development site to one or more other sites: …

Bioequivalence data arising from a two-period crossover trial are routinely analyzed to
establish equivalence of the population means of a characteristic of the blood level curve, for …

Purpose The aim of this study was to evaluate a human meibomian gland epithelial cell line
(HMGEC) as a model for meibomian gland (patho)physiology in vitro. Methods HMGEC …

Thyroid hormone mimetics are alluring potential therapies for diseases like dyslipidemia,
nonalcoholic fatty liver disease (NAFLD), and insulin resistance. Though diiodothyronines are …

… 4.3 and 81.2 f 7.1, respectively. Corresponding values for the second … f 4.3 and 77.2 f 4.9;
the third (n= 15) were 59.1 f 4.2 and 69.1 f 4.6; and the fourth(n= 15) were 63.9 f 7.0 and 73.6 f …

… Extracellular GABA (A & B), glutamate (C & D), and glycine (E & F) levels are expressed
as a percentage of the respective mean baseline value ± standard error of the mean for each …