Drug unit

The University of Navarra has a unit that offers the possibility of conducting, in one location, the pre-clinical and clinical development of drugs (whether small molecule or biological) that can lead to the marketing stages.

The following are the different studies that can be undertaken with the University of Navarra:

Formulation studies:

  • Pre-formulation studies and design

  • Physical and chemical characterization

  • Solubility profile (in aqueous and non-aqueous solvents)

  • Forced degradation and chemical reactivity studies

  • Optimization of the development process

  • Compatibility of excipients

  • Development of formulations for safety trials

  • Development of commercial formulations

  • Optimization and development of lyophilization

  • Particle size analysis

  • Technology transfer and scale-up

Development of pharmaceutical forms:

  • Solids: oral, topical, granules, hard-shelled capsules, tablets

  • Liquids: oral and topical

  • Injectables

  • Ophthalmic preparations: eye drops, ointments

  • Semisolids: ointments, pastes, emulsions, gels

  • Forms of rectal administration: suppositories, enemas

  • Freeze-dried products

  • Micro- and nanoparticles

Analytical/bioanalytical and stability studies

  • Development of analytical methods

  • Validation of analytical methods

  • Sample quantification center

  • Stability studies Temp/RH controlled conditions             

  • ICH guidelines (climatic zones I - IV)

  • In-use stability studies

  • Ongoing stability studies

Toxicological studies

  • General toxicology: single dose, repeated doses and maximum tolerated doses

  • Specific toxicology: local tolerance, irritation and genotoxicity studies

  • Different animal models with different routes of administration

In silico PK/PD studies

Using data from primary studies and through biopharmaceutical and pharmacokinetic/pharmacodynamic PK/PD modeling, a population analysis is conducted to predict the clinical response in early stages. This type of study enables us to reduce the development cost and time, as well as carry out an appropriate redesign at an early stage.

 

Research Management Service

Xavier Tapias Mateu
BD & Project Management in Biotech/Pharma Development
xtapias@unav.es

General contact:
Pío XII, 53
31008 Pamplona
Spain

+34 948 17 67 48
Ext. 83 2149
xtapias@unav.es