Pre-clinical studies are preliminary tests and are an important part of ensuring that a human clinical trial is necessary. They are designed to test the efficacy, safety and toxicity of the product and are generally performed using cells, tissue samples, or animals. NovoBliss expert team of regulatory and toxicology specialists can help you build the best pre-clinical tests to ensure your clinical trials are successful.
Animal models have been proven to be not perfect for dermocosmetics testing, since animal models do not accurately represent the structure of human skin. In-vitro, ex-vivo techniques can aid skin research which can be adapted to study a range of conditions in order to more accurately study human skin diseases and aid drug development.
Compared with in-vitro skin models, ex-vivo models can be more accurate on representing the human skin in some case, such as the effect of the extracellular matrix (ECM) in terms of structure, cell signaling mechanisms and the processes of metabolism, the incorporation of skin appendages such as hair follicles and sweat glands, and the effects of dermal absorption. Ex-vivo human skin is more appropriate for certain types of research, use of whole skin biopsies in culture allows the effect of individual ingredients and formulations, transdermal delivery, topical penetration and percutaneous absorption to be tested in an environment more closely mimicking normal skin.
NovoBliss provides highly predictive & cost-effective ex-vivo human skin model & various ingredients & formulation screening services in laboratory conditions prior to in-vivo clinical evaluations for your cosmetics and dermatology products.
Fig.1 Histological examination of H&E-stained skin cryosections showing the morphology of the stratum corneum, epidermis, and dermis.