Evaluation of drugs without animals.

REMA (The Spanish Network of Alternative Methods).




Domingo Gargallo (Ferrer International. Toxicology and Safety  Pharmacology Barcelona)

Joan Albert Vericat (Noscira. Madrid. Spain)



Review the different possibilities today available to reduce the attrition rate during regulatory non-clinical and clinical development. Is there enough information available in early screening to conduct a limited safety assessment? Until which degree animals can be removed from non-clinical development?


Lecture 1:

Introduction I: The Regulatory Frame in Non-Clinical Drug:

Genetic Toxicology Early Screening


Esperanza Herreros and Santiago Ferrer (In vitro Toxicity and Toxicity, GSK, Madrid)


Lecture 2:

Introduction II: The concept of the 3Rs+R2 (= Replacement, Refinement, Reduction + Responsibility in Research); attrition rates and overview of existing non-animal approaches


Joan Albert Vericat (Noscira. Madrid. Spain)


Lecture 3:

Genetic Toxicology Early Screening (30+10 minutes)


Domingo Gargallo (Ferrer International, Barcelona)


Lecture 4:

Metabolism & ADE; (1) Metabolism. (2) ADE & Modeling.


Lourdes Gombau (Avancell, Barcelona)

José Vicente Castell (Centro Investigación, Hospital LaFe, Valencia)


Lecture 5:

Need for complexity: Integration in vitro and in vivo activities


Joan Albert Vericat (Noscira. Madrid. Spain)


Lecture 6:

Points of view of Regulatory Authorities


Federico Goodsaid (US-FDA)


Final Discussion:

Open discussion and take home messages.