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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Clinical safety (clinical pharmacology studies)

Clinical safety and dose level selection is initially explored through clinical pharmacology studies.

BioVentures Consulting Limited is able to write the clinical study reports including an interpretation of t½, Cmax, AUC data for subsequent dose level selection

BioVentures Consulting Limited can help design, run report any aspect of the clinical pharmacology package in order to support drug development; and has the experience and expertise to project manage the clinical pharmacology programme. These studies may include a first-in-man clinical trial such as single ascending dose studies and multiple ascending dose studies in healthy volunteers. BioVentures Consulting Limited is able to write the clinical study reports including an interpretation of t½, Cmax, AUC data for subsequent dose level selection.

BioVentures Consulting Limited can also support additional clinical pharmacology studies which are conducted throughout the development and product life-cycle including studies in special populations, such as elderly patients and renally impaired patients, and phase IV studies in selected patient populations (ethnic groups).

A complete clinical pharmacology package is also likely to contain an analysis of population pharmacokinetics as a subpopulation from the large phase III clinical studies. BioVentures Consulting Limited is able to interpret these data in the context of the broader clinical pharmacology programme.

Interpretation of clinical pharmacology data (pharmacokinetics and pharmacodynamics) is also applied to bioequivalence studies and bioavailability studies. These studies may be needed in comparator studies such as those needed in the development of generics. BioVentures Consulting Limited has helped design, run and report such studies for its clients.

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