DRUG DISCOVERY The environment constructed around UNAV, has contributed to establish it as a reference in the field of Biomedicine, offering and applying our high experience in the development of drugs from bench to patient.
UNAV possess capabilities focused on discovery of new entities and therapeutic targets. Our objectives:
As a result of the experience in drug development, UNAV owns the Drug Development Unit Universidad de Navarra (DDUNAV). This Unit supports the Preclinical and Clinical Development (Phase I to Phase IV Studies) of Biotech and Pharmaceutical Companies.
Translate basic science into therapeutic opportunities.
The Unit offers a full range of services that include: drug formulation, development and validation of analytical methods, toxicological studies, efficacy studies, PK/PD modelling and Clinical Trials. All competences are covered by quality standards.
Participating in a wide range of drug development projects from bench to clinical phases.
Facilitate innovative discovery.
UNAV Faculties: Pharmacy, Medicine, Biology, Biochemistry and Chemistry.
General Toxicology: Acute Studies & Subchronic Studies (basic safety Tox). Specific Toxicology: Local Tolerance; Skin and Eye irritation/corrosion, Mutagenicity & Genotoxicity. Pharmacokinetics & Toxicokinetics studies in vivo. Animal model development & Efficacy Studies in vitro & in vivo. Experimental models: Rat, Mouse, Guinea pig, Hamster, Rabbit, Dog, Mini Pig, Non-Human primates & Others. Administration routes: Oral, Intravenous (bolus or Infusion), Intraperitoneal, Subcutaneous, Dermal, Vaginal, Intravitreous, Ocular…
CLINICAL FACILITIES
PK/PD MODELLING This Unit builds mechanistic models describing and predicting the time course of disease progression: Physiological and mechanistic models to correlate drug dosage with pharmacological responses.
University Clinic of Navarra is a referential healthcare centre in the field of Biomedicine that covers the whole process of therapeutic and diagnostic product development, from basic R&D to clinical practice. Fields highlighted: Oncology, Haematology, Dermatology, Cardiology, OTR, Neurology. Last five years: 250-300 Clinical Trials: Phase I: 15%, Phase II: 40%, Phase III: 40% and Phase IV: 5% Other CUN facilites: Cell Therapy Laboratory (GMP Production), Radiopharmacy Unit (PET Tech) & Clinical Genetics Unit.
Prediction of Clinical Response.
Each drug development project is designed under highest scientific quality in a cost effective and efficient mode.
MORE... High experience in preclinical development under contract and a flexible structure adaptable to Company´s needs.
TOXICOLOGY_ GLP
Each project is assigned to a project manager, who is the reference in all communications between the client and our scientific team.
UNAV has created two specialized centers which collaborate and complement the research offer: The Center for Applied Medical Research: Oncology, Neurosciences, Cardiovascular Sciences, and Gene Therapy & Hepathology and the Institute of Tropical Health: Brucellosis, Chagas disease, Leishmaniasis and Malaria.
FORMULATION
ANALYTICAL & BIOANALYTICAL_GLP
Desing and Pre-formulation studies.
Development and Validation Analitycal and Bioanalytical methods.
Process development optimization.
Quantification of animal & clinical trials samples.
Excipient compatibility studies.
Stability studies: according ICH guidelines.
Commercial Formulation Development. Technology transfer and scale up.
Equipment available: Capillary electrophoresis; DSC; HPLC (UV, Fluorescence); LC-MS (TOF, Ionic Tramp, QqQ) & GC-MS.
PHASE I UNIT This Unit is focused on drug monitoring in the body. The facilities feature 8 beds to develop the following activites:
Pharmacokinetics & Pharmacodinamics studies. Bioequivalence studies. First-in Human studies. Dose-finding studies. Tolerance studies.
PHASE II-III-IV Our Clinical Units conduct a large number of Clinical Trials in collaboration with Biotech and Pharma Companies. The clinical trials cover a total of 27 different medical areas, in wich 3500 individuals have participated over the last five years.
Using DDUNAV like a One Stop Shop, will provide your organization with a great benefit in the drug development management. DDUNAV offers services in all the stages of Drug Development; this will enable businesses to save on resources, in order to be more competitive in the current market. All these competences are focused on ensuring that the expectations of the customers will be met.
AVDA. PĂ?O XII,53. 31008 PAMPLONA_SPAIN P 0034 948 176 748 M sgi@unav.es W unav.edu