In 2018 the FDA and several other regulatory bodies are expected to enact and enforce more laws related to the requirements for nonclinical drug-drug interaction (DDI) studies prior to an IND. A key component of developing a drug for market-use is to test for how it might interact with other drugs or substances in the body.
Here’s an overview of what a DDI is and how it effects the drug development process.
Implementing population modeling, commonly called Pop PK/PD, for your pharmacokinetic (PK) or pharmacokinetic/pharmacodynamics (PK/PD) analysis is an essential tool of the drug development process and, in some demographics (like infants), a necessity.
The immune system is the body’s main defense against foreign materials and biologic agents such as bacteria, viruses, chemicals, and foreign cells and tissues. The immune response includes specific action of lymphocytes (one type of white blood cell) and is facilitated by other white blood cells, including neutrophils, monocytes, macrophages, eosinophils and basophils. The immune system can be viewed as a system controlled by negative feedback, meaning that normally it must reduce the effects of disturbance or invaders through self-regulation. Continue reading
Covance is proud to announce that Xcellerate® Trial Design has been selected as the winner of the Fierce Innovation Awards: Life Sciences Edition in the Data Analytics/Business Intelligence category. The Fierce Innovation Awards: Life Sciences Edition recognizes outstanding innovations that are driving improvements and transforming the life sciences industry. Xcellerate Trial Design was recognized for its innovative approach to improving site selection, forecasting resource demand and optimizing of clinical trial design. Continue reading