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Drug development unit. Services for companies. Research. University of Navarra

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Drug Development Unit

The development of the University of Navarra in the biomedical area has contributed to establish itself as a reference in this field, offering our extensive experience in the complete development of drugs.

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What is?

The University of Navarra has created the Drug Development Unit. The unit ranges from preclinical development to clinical development (Phase I to Phase IV) with the purpose of serving the pharmaceutical and biotechnology industry.

We offer a full range of services including, drug formulation, analytical method development and validation, toxicology studies, efficacy studies, PK / PD modeling, and clinical trials. All these services are covered by the highest quality standards.

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Preclinical development

The Galenic Development area offers the following capacities, both for "small molecules" and for biological products:

  • Design and formulation studies.

  • Characterization of physical properties.

  • Chemical reactivity and forced degradation studies.

  • Optimization of the development process.

  • Excipient compatibility studies.

  • 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 license agreements or collaborative projects with companies in the sector.

The Analytical area carries out development, validation, "Tech Transfer" and custom development of analytical methods according to the requirements of the company.

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

  • The Unit is certified under GLP.

  • 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; (CE) DAD; (DSC).

  • ICH Stability Studies (Temperature and Controlled Humidity) covering climatic areas I to V.

The Toxicology area has extensive and recognized experience in biosafety studies under GLP certification for the Pharmaceutical Industry, using different dosage regimens, different animal species (from rodents to primates) and a wide variety of administration routes (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 and Dermal Irritation / Corrosion Studies, Mutagenicity and Genotoxicity.

  • Pharmacokinetic and toxicokinetic studies.

  • Expertise in the 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 dissolution profiles.

  • PBPK modeling: early prediction of human pharmacokinetics.

  • Pharmacokinetic / pharmacodynamic modeling: description of the relationship between drug concentration profiles and their effect on biological markers.

  • Population PK / PD analysis: development of descriptive models of clinical outcomes (eg survival) based on information from ECCE phase I-III.

  • Design optimization: designing future in vitro and in vivo development strategy based on statistical considerations and computational simulations.

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


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

The microbiological tests are carried out following the guidelines of the latest version of the Pharmacopoeias and include, among others:

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

  • Validation of microbiological control methods in pharmaceutical products.

  • Microbiological tests on pharmaceutical products (stability studies).

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

  • Microbiological control of water for injections.

  • Sterility test of pharmaceutical products.

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Clinical development

The University of Navarra Clinic (CUN) covers the development of therapeutic or diagnostic products, from basic R&D to clinical practice.

The 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 the Clínica Universidad de Navarra (around 27) participate in clinical trials.

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

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Contact

Xavier Tapias Mateu

Deputy Director of Valuation and Transfer

Edificio Muga Avda. Pío XII, 53

31008 Pamplona, Spain

+34 948 176 748

Ext. 832149

"contactar con Xavier Tapias Mateu"

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