SocraTec R&D Clinical Investigations - Phase-I-Studies: Bioavailability, interaction studies and more

Bioavailability, interaction studies and more

Phase-I projects form the main part of the work carried out in our Clinical Pharmacology Unit in Erfurt. Every healthy volunteer or patient, sometimes up to 60 subjects in parallel, receives the same high standard of management and care. An optimum study protocol, standardised to the last detail and carefully matched to the aims of the investigation, helps to reduce study variation as far as possible and provides for reliable results.

Every year hundreds of volunteers and patients are involved here in studies dealing with a variety of scientific questions e.g.

	Pharmacokinetics (LADME, dose linearity and proportionality, gender or age dependence, tissue distribution etc.)
	Bioavailability and bioequivalence after single doses and at steady state
	Interaction studies (drug-drug and drug-food)
	Investigations with controlled substances (e.g. opioids)
	Impact of genetic factors and impaired organ function on bioavailability and pharmacokinetics
	In-vitro-/in-vivo correlations (IVIVC)
	PK/PD modelling
	Dose-escalation studies (including estimation of maximum tolerated dose)
	Skin irritation and skin sensitization studies (according to FDA Guidelines), photosafety and phototoxicity studies (estimation of MED and MTD)

We provide all service and would appreciate being involved in the planning, organization und the carrying out of your clinical projects. Suitably trained and experienced personnel are available to ensure that the studies are completed on time and in accordance with your requirements.