Influence of Different Populations on Pharmacokinetic Bioequivalence Results: Can We Extrapolate Bioequivalence Results from One Population to Another?

Unlabelled: Purpose: Over the last 15 years, an ever-increasing proportion of pharmacokinetic bioequivalence studies for European/North American generic submissions appeared to have been conducted in geographical/ethnic populations other than those for which the drug is marketed for. The results of pharmacokinetic bioequivalence studies have traditionally been considered to be insensitive to the population studied. However, several recent studies have suggested that this may not necessarily be true.

Levothyroxine soft capsules demonstrate bioequivalent pharmacokinetic exposure with the European reference tablets in healthy volunteers under fasting conditions.

Objective: To assess the bioequivalence (BE) potential under fasting conditions between levothyroxine soft capsules and the European reference tablet formulation.

Methods: Two studies were conducted to assess the BE potential as per European regulations. Study 1 was a two-way crossover BE study comparing a high strength of levothyroxine soft capsules versus levothyroxine tablets (200 μg), while study 2 was a three-way crossover dosage form proportionality study between low, medium, and high strengths of soft capsules.

Proinflammatory cytokine and chemokine modulation by Streptococcus suis in a whole-blood culture system.

Streptococcus suis is an important swine and human pathogen. Inflammation, a hallmark of S. suis infection, is thought to be responsible for most clinical signs of meningitis, septicaemia and sudden death.

Pro-inflammatory cytokine and chemokine release by human brain microvascular endothelial cells stimulated by Streptococcus suis serotype 2.

Streptococcus suis serotype 2 is a world-wide agent of diseases among pigs including meningitis, septicemia and arthritis. This microorganism is also recognized as an important zoonotic agent. The pathogenesis of the meningitis caused by S.