Why and when it is important to use imaging systems in pre-clinical trials The whole purpose of pre-clinical trials is to test a medical intervention for its safety and efficacy before clinical testing on humans. Using imaging systems before, during and after a pre-clinical trial provides essential data on the effects of the device, procedure or drug being tested. While it is easy to understand the value of imaging during and after the trial, some might question the need for using imagery on an animal before beginning the trial. In addition to giving a precise view of the organ or

Pre-clinical, in-vivo studies are performed to evaluate newly developed pharmaceuticals and medical devices, in terms of safety, efficacy, toxicity, functionality and so on, prior to application in clinical use. Ethical conduct in pre-clinical, in-vivo studies is intended to ensure that animals will not be unduly harmed and to ensure that the Best Clinical Practices (BCP) are employed when engaging in animal experimentation. The concept of ethics in animal experimentation is not new. The book, The Principles of Humane Experimental Technique1, by Russell and Burch, first published in 1959, had an unprecedented impact on what has become the norm for today’s

Pre-clinical Studies require a great deal of equipment, professional know-how, experienced researchers, and clinicians. They also require animal models. While the Biotech or Medtech companies are the experts in their niche, matching the most suitable animal model to the specific device and specialty is not an easy task.  When choosing an animal model there are many factors that need to be considered, including regulatory standards and ethics, the suitability of specific species to match the product specialty, anatomical differences between humans and animals, the age of the animal, as well as trial length, and the availability of that species. Lahav

How to choose a large animal model for preclinical studies – Sheep models In our previous blog we discussed Swine models and the many factors involved in choosing the most suitable animal model including regulatory standards and ethics, the suitability of specific species to match the product specialty, anatomical differences between humans and animals, etc. Lahav CRO specializes in pre-clinical testing with large animal models including swine and sheep. Here we will discuss the characteristics of various sheep models and briefly explain their suitability for various pre-clinical studies.   Sheep as animal models – advantages There are many reasons for

Sheep as an animal model for orthopedic studies – The suitability of sheep for orthopedic models. In our previous blog, we discussed how to choose a large animal for preclinical studies and focused on Sheep models. Here we will delve in deeper and discuss ‘why’ and ‘what’ makes sheep models suitable for preclinical studies, especially in the field of orthopedics.  Comparative anatomy – spine While it might not seem obvious, the anatomical bone structure of sheep is indeed similar to human bone structure, especially the spine. Given that sheep do not stand in an upright position (vertical posture), the visual

When developing a medical device or pharmaceutical, we often jump to thoughts of getting approval from a regulatory authority (e.g., FDA or CE). However, in order to get that approval and be able to sell your product, everything leading up to the request for approval has to be objectively defined complying with the most strict reliability standards. This is where Good Laboratory Practice Comes in. Without GLP-compliance, receiving approval based on your pre-clinical trials, will be very hard to achieve.   If this sounds intimidating, it should. That is why we are writing this discussion and that is also why it