For those who may not yet know it: humans are in the Kingdom Animalia, just like mice, monkeys, chimps and other "animal models," which, by the way, are used in research because of their close resemblance to the human immune (and other body) systems...True, preclinical trials on OTHER animals is not identical to trials on humans; but, don't be led astray on the science by the scientifically illiterate on this board trying to pretend that successful OTHER animal trials have no relevance to portending successful human trials...INO is looking exceptionally strong with their vaccines/vaccination technology that is revolutionizing the medical field...imho, we see a big rise in pps during the next 6-12 months...When it will happen, not certain (though a triple recently does count for a "big rise" in pps)...I am talking about hitting $5-10 in the next 6-12 months...Again, my opinion, but the science here is very strong and provides valid evidence that we will be moving upward significantly...I for one, am anxiously awaiting the malaria HUMAN animal trials in early 2014...Should those trials show efficaciousness of the vaccine, look out!$ Best wishes to all from the greatest animal viewing destination on the planet--Kenya!$
The specific terms that characterize this concept are "translational research" based on "comparative medicine." Laboratory animals which have systemic physiology and responses similar to humans are used to produce preclinical safety and efficacy data. These data are used to estimate "potential risk to benefit" for use in humans. Factors like dose response curves, frequency of dosing, route of dosing, impact on immune system, target organs, etc. (toxicity), reproduction, carcinogenicity potential, etc. are all assessed to provide data for planning a human clinical trial. There are some general thumb rules that have evolved across 50 plus years of evolution of testing drugs, biologicals and medical devices - synthesized drugs are not necessarily natural compounds and can have more side effects if not used according to the specific label copy. Biologicals are generally natural compounds which have less side effects but can also cause problems if given in doses which exceed prescribed limits. Devices just need to be made from biocompatible materials and need to mimic some medical need (artificial kidney), deliver a drug, moderate failing function (pacemaker), or substitute for a body part (artificial hip).
But the important point is that we use preclinical animal studies to really pin down safety. I use to have a great veterinarian come in every year and teach my veterinary students. She would walk back and forth during her introduction and ask two questions. "How many of you, if you had a debilitating disease (not one that would kill you tomorrow) would allow a drug to be used on you which had never been tested for its safety in animals?" 10-15 hands among 65 students would go up. She would then look the students right in the eyes and say, "How many of you would allow that same drug to be used on your child?" All the hands came down. EOS