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.
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