Promotion of Non-Clinical Studies Business

Support of Non-Clinical Studies with large animals

  • Study coordination based on related organizations network in japan.
  • To be entrusted with animal management before, during and after, animal experimentation.
  • Priority supply of “MicrominiPig ”, one of world's smallest micro pig made in japan.

The need for large animal experimentation

Requires experimentation in a environment close human more.
In clinical trials for pharmaceuticals and medical devices, “no effectiveness” in P2 and P3 studies is the biggest cause of test failure. On the other hand, pharmaceutical approval system of japan, since 2017, conditional early approval system has started operation about drugs and medical devices for serious diseases become possible to approve without P3 testing on condition that reconfirm safety and efficacy after launch. By this system, increases the speed of drug discovery and medical device development, and the development of more innovative treatments is expected. But if judged approved drugs and medicaldevices “no effectiveness” after start of treatment, the patient who received the treatment will be forced a great and unnecessary financial and physical burden.
 
Therefore, it is important to verify the effectiveness carefully in non clinical studies. Many non-clinical studies use small animals such as rats and mice. The non clinical studies use small animals are easy to perform because the procedure is easy and the cost can be kept low. However, in the development of human medicine and medical devices, even if effectiveness is recognized in small animals different from humans in various respects, it is not necessarily effective for humans. In addition, the drafted by FDA in 2015, "General Considerations for Animal Studies for Medical Devices" recomending that the test environment be as close to the clinical environment as possible because in animal studies requires not onlyevalutation of safety but also evaluation of performance and operability.

For these reasons, it is necessary to non clinical studies use large animals that can be tested in conditions and environments that are closer to humans.

Difficulties animal studies used large animal

Obstacles of tangible factors

  Animal studies using large animals require facilities specially designed for testing and breeding management, unlike animal studies using small animals such as mice and rats.

Obstacles of intangible factors

  Animal studies used large amimals require personnel with veterinary expertise for animal studies and subsequent rearing management.

Obstacles of cost factors

  Compared to the animal studies used small animals, just the price of the large animal is about 100 times higher, and in addition to this, when it comes to aligned the tangible factors(facility etc.) and intangible factors(personnel etc.), the cost will increase further.
We support for conducting 
more effective animal studies beyond these obstacles.