The area of development Galenic, offers the following capabilities, both for small molecules and biological products:

• design and formulation studies.

• Characterisation of physical properties.

• Chemical reactivity and forced degradation studies.

• Optimisation of the development process.

• Compatibility studies of excipients.

• Preliminary process identification.

• Commercial formulation development.

The unit offers extensive expertise in nanotechnology and drug delivery systems (mainly in cancer, infectious, cardiovascular and neurodegenerative diseases). The aforementioned expertise is protected by patents and transferred to society through agreements with licence or collaborative projects with companies in the sector.

The Analytical area carries out development, validation, "Tech Transfer" and development tailor-made analytical methods according to the requirements of business.

The Bioanalytical area carries out the development and validation of bioanalytical methods, as well as offering the analysis of animal samples and samples from clinical trials.

The Unit is GLP certified.

• development and Validation of analytical methods.

• Analysis of samples from animal studies or clinical trials. 

• Transfer of Analytical Methods

• Chromatographic analysis: HPLC-UV, HPLC-FLD, HPLC-MS/MS; GC-MS; (EC) DAD; (DSC).

• ICH Stability Studies (controlled temperature and humidity) covering climatic areas I to V.

The Toxicology area has extensive and recognised experience in biosafety studies under GLP certification for the Pharmaceutical Industry, using different dosing regimens, different animal species (from rodents to primates) and a wide variety of routes of administration (parenteral, enteral, topical, subcutaneous, oral, ocular,...).

• General Toxicology: Single Dose Studies, Repeated Dose Studies, Maximum Tolerated Dose Studies and Immunogenicity Studies.

• Specific Toxicology: Local Tolerance, Eye Irritation/Corrosion, Dermal, Mutagenicity and Genotoxicity Studies.

• Pharmacokinetic and toxicokinetic studies.

• Expertise on development of animal models.

• Efficacy studies: in vitro and in vivo models.

The PK/PD Modeling unit develops mechanistic models for the description and prediction of the evolution of diseases, and the action of the drug in each of the stages of the development of a new drug.

• In vitro - in vivo correlation: in vivo pharmacokinetic prediction based on in vitro dilution profiles.

• PBPK modelling: early prediction of human pharmacokinetics.

• Pharmacokinetic/pharmacodynamic modelling: describing the relationship between drug concentration profiles and their effect on biomarkers.

• Population PK/PD analysis: development of clinical outcome descriptor models (e.g. survival) based on data from phase I-III CCTS.

• Optimisation of design: designing the future strategy of development in vitro and in vivo based on statistical considerations and computational simulations.

• Personalised medicine: selection of the right drug (or combination) and the correct dosage for each patient.

Recognition by the Government of Navarra of compliance with the Principles of Good Practice of laboratory (GLP) for the performance of microbiological studies of antibiotic efficacy, fungicidal efficacy, preservative efficacy and stability studies (Resolution 335/2016).

Microbiological tests are performed according to the guidelines of the latest version of the Pharmacopoeias and include among others:

• Bactericidal, fungal and preservative efficacy studies (MIC and MBC determination, antibiograms).

• Validation of microbiological control methods in pharmaceuticals.

• Microbiological testing of pharmaceuticals (stability studies).

• Validation of the productivity of culture media used in the microbiological control of pharmaceutical products.

• Microbiological control of water for injections.

• Sterility testing of pharmaceutical products.

The Clínica Universidad de Navarra (CUN) covers the development of therapeutic or diagnostic products, from basic research and development to clinical practice.

CUN has participated in 250 clinical trials in the last 5 years, in collaboration with a large number of biotechnology and pharmaceutical companies, offering the following capabilities:

• Phase I Unit: the unit offers 6 beds and a bioanalytical unit for the development of drugs in early clinical phases.

• Phase II to Phase IV trials: all areas of Clínica Universidad de Navarra (around 27) are involved in clinical trials.

Most of the clinical trials have been developed in the areas of Medical Oncology, Haematology, Cardiology, Hepatology, Psychiatry, Ophthalmology and other services.