The Clinical Department of UNIFARM provides an extensive pharmacokinetic (PK) and pharmacodynamic (PD) support in pre-clinical and Phase I-III clinical studies in accordance with international regulatory standards (FDA, EMEA, ICH).
Services:
-preclinical development;
-pre-clinical PK;
-study design;
-bioequivalence and comparative bioavailability;
-modified release formulations;
-PK/PD Modeling and simulation;
-PD profiling of pharmacological effects;
-statistical analysis of PK and PD outcomes.
Therapeutic areas:
Over the years, UNIFARM has developed a considerable experience in many therapeutic areas such as:
-Neurology;
-Oncology;
-Gynaecology;
Metabolism;
-Ophthalmology;
-Transplant pharmacology.