Phase I

PHARMALOG has extensive experience of planning, coordinating, evaluating and reporting pharmacokinetic and bioavailability studies.

Clinical Phase I competence includes:

• Study design
• Cooperation in preparing and reviewing the clinical study protocol
• Selection of a suitable partner phase I unit (Inpatient) or appropriate study centre (Outpatient)
• Study coordination
• Study monitoring
• Pharmacokinetic & pharmacodynamic evaluation with WinNonLin software
• Non-compartmental and compartmental analysis
• Bioavailability / bioequivalence assessment evaluation of clinical data with SAS software
• Preparation of integrated clinical/pharmacokinetic reports, observing relevant ICH guidelines