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“The maternal cardiovascular system is different, as well as the hemodynamics, the immunology and the pharmacodynamics.”

Luther and colleagues’ chimaeras are at a more advanced stage of development, because, as the authors show, they have potent in vivo activity as well as favourable toxicity, pharmacokinetics and pharmacodynamics in animal models.

Healing of pathology may also be compromised in this adverse environment given the immune dysregulation, increased steroid stress hormones, heightened microbial virulence and altered drug pharmacodynamics in space.

Such studies are becoming more and more common, EMA writes; for instance, the trial in Rennes included subtrials using single and multiple dose administration, as well as trials on drug interactions with food and on pharmacodynamics, the study of a drug’s biochemical and physiologic effects on the body.

Many of the actionable pharmacogenes that have been identified to date exert a strong effect on the pharmacokinetics or pharmacodynamics of their associated drug, which make them easy to identify.