3 services found
Envigo services
Discovery Services
There are many qualities that differentiate a chemical from a drug. From therapeutic efficacy to it"s first-pass metabolism in man, there are a variety of characteristics that make it more, or less, likely that a chemical will make an effective and safe therapeutic. At Huntingdon Life Sciences, we recognise that it can be vitally important to understand as many of these characteristics as possible before committing to animal and human trials. We have therefore devised a suite of services designed to give you the maximum amount of information about your candidate molecules.
Pharmaceutical Analysis Services
Characterisation of a biopharmaceutical product, determination of physico-chemical properties, biological activity, immunochemical properties, purity and impurities by appropriate techniques is essential for identifying the key characteristics of the product that should be considered when setting specifications for the product. These should be defined prior to conducting early clinical studies since they are essential for demonstrating product and process consistency and quality as well as demonstrating comparability, i.e. that a product used in early studies is the same as that intended for marketing.
Phase I Enabling
A Phase I study is a safety trial in a small number of healthy human volunteers or patients. It is typically the first human exposure to a New Chemical Entity (NCE) and takes place in a controlled clinical setting. To be granted permission by the regulatory bodies to perform such a study, a comprehensive package of toxicology data, demonstrating safety at many times the human dose in animals, must be submitted. Damage at the gene or chromosomal level can be investigated using in vitro tests in dividing cells. Toxicology investigations require data in two animal species, usually one rodent species, and one non-rodent species. Animals must be dosed in a similar way to human volunteers and for a duration that is equal to or exceeds the clinical protocol. In addition, safety pharmacology studies must be performed to evaluate possible effects on the cardiovascular, respiratory and central nervous systems.
