Haemodynamics assessment

Most safety pharmacology studies with haemodynamic assessments may include a control treatment group tested under the same conditions of the dmg being considered for development. The presence of a control group is particularly important for statistical analysis. However, it remains that some designs may not require a dedicated control group. Early safety screening studies in anaesthetized rodents or... 

Logistical and Technical Considerations in the Conduct of Haemodynamic Assessments... 

Walmsiey, B.H., Fleming, J.S., Ackery, D.M., Karran, S.J. Non-invasive assessment of absolute values of hepatic haemodynamics using radiocolloid scintigraphy. Nucl. Med. Com. 1987 8 613-621... 

At the same time, the elevated sinusoidal pressure values transmit biochemical signals for a compensatory retention of sodium in the renal tubules. Likewise, functional hyperaldosteronism occurs at an early stage and the sympathoadrenergic system is activated with its impact on the splanchnic and renal haemodynamics both events serve to counter volume deficiency and hypotension. The physiological effects of the various biochemical factors may vary under pathological conditions, depending on the respective ascitic phase for this reason, they can be difficult to assess. Reciprocal interactions also render it more difficult to evaluate the individual factors. 

It is standard practice in safety pharmacology to conduct a power analysis (i.e. establishes the sensitivity of the statistical test or the ability of a test to detect an effect, if the effect exists) by using data derived from each nonclinical model in order to assess the minimum detectable difference (MDD) for the parameter to be investigated. With regard to blood pressure changes, an effect size of 14-16 % (Ewart et al. 2013) was calculated as the MDD for haemodynamic measurements... 

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