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Pharmacodynamics Model

Source: ICON

Translational Medicine

With over 15 years of experience in clinical pharmacodynamics, ICON's skilled team of scientists can give you the cutting edge you need.

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In recent years there has been increasing interest in the application of biomarkers and surrogate endpoints in healthy volunteer studies to provide pivotal information on efficacy, dose-response and time-effects of drugs.

With over 15 years of experience in clinical pharmacodynamics, ICON's skilled team of scientists can give you the cutting edge you need.

The main focus in Phase I clinical trials has traditionally been in assessment of safety and tolerability. However, in recent years there has been increasing interest in the application of biomarkers and surrogate end points in healthy volunteer studies to provide pivotal information on efficacy, dose-response and time-effects of drugs.

There is a growing pressure within the pharmaceutical industry to develop medicines as quickly and costeffectively as possible. Early read-outs on putative efficacy or potential obstacles can be hugely beneficial in achieving this. Our cutting edge pharmacodynamic models can provide this for you. 

ICON has worked extensively in this area, developing and validating models for investigating a range of therapeutic targets, as part of its own research and development efforts and in partnership with Sponsors. These techniques fall broadly into two categories:

1. Pharmacodynamic Models of Disease State
Use of healthy volunteer models has proven to be fast and reliable for determining if a drug has the necessary characteristics to be taken forward into more expensive patient trials. The dedicated Clinical Pharmacodynamics group at ICON has developed and validated a variety of pharmacodynamic models in a broad range of therapeutic areas including:

  •  Pain (acute and chronic)
  •  Inflammation
  •  Appetite/Obesity
  •  Anxiety
  •  Cognitive Function
  •  Metabolic Function/Diabetes
  •  Sexual Dysfunction

2. Techniques Designed to Initiate Specific PD Responses
When a protocol requires the inclusion of a specific technique that is out of the normal scope of a CPU, the PD group is responsible for identifying, validating and testing the equipment. A wide list of techniques is offered by ICON covering tests for sedation, CNS imaging, physiological assessments and mood assessments.

Validated pharmacodynamic models allow the effect of an investigational compound to be determined on symptoms induced under controlled conditions. In healthy subjects they offer a rapid and cost-effective method of assessing the effects of a molecule and in determining its future potential. They can also provide an additional means of ensuring that the best candidate is selected for development in situations where multiple compounds exist in a pipeline.