Dogs and monkeys in preclinical drug development: the challenge of reducing and replacing.

Introduction: Animal experimentation is a very contentious issue affecting reputation of drug industry. There are several reasons to forecast an increase in the number of dogs and monkeys used in safety and pharmacokinetic studies. This increase may trigger a strong reaction of the public opinion. There have been many proposals and initiatives to change the present approach to safety and metabolic studies. Tests based on new technologies, in vitro cell assays, stem cells, imaging, and computational systems, have the potential to anticipate effects in humans. Unfortunately, all these efforts and ideas have not changed standard approaches and regulatory expectations.

Areas Covered: This review looks at opportunities to reduce the number of dogs and monkeys currently used in pharmaceutical research. It also discusses present efforts and approaches, their strengths and potentials and the reasons why they may not fulfill expectations.

Expert Opinion: Unless the pharmaceutical industry gets more involved, an alternative paradigm of preclinical drug development is unlikely to be established in the foreseeable future. One can imagine a scenario where the political pressure against the use of dogs and monkeys in biomedical research becomes irresistible while alternative methods are not yet established. To avoid this situation, the pharmaceutical industry should take the lead and preclinical scientists at all levels need to influence decision makers and help develop new innovative approaches in drug safety evaluation.