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Optimizing Safety Pharmacology Programs to Promote Efficiency and Animal Welfare

The primary objective of safety pharmacology studies is to identify potential adverse functional effects of a compound on the central nervous, respiratory, or cardiovascular systems. Like many areas of drug development, safety pharmacology is a [...]

By | October 7th, 2016|Categories: Blog|

To BDC or Not to BDC – That Is the Question

Andrew Augustine, MS, Senior Study Director, DMPK One of the primary functions of the liver is to manufacture bile, which is necessary for the digestion of fat and elimination of drugs and their metabolites. Metabolism [...]

By | September 1st, 2016|Categories: Blog|

Lessons Learned in Preparing Nonclinical Programs Part I:

Test Article Considerations Effects: Sharing as much information as you can with your contract research organization (CRO) about your test article and its known or potential effects is a critical component of the study [...]

By | July 10th, 2016|Categories: Lessons Learned: Nonclinical Programs|

Lessons Learned in Preparing Nonclinical Programs Part II:

Species Selection The basic question that helps to address this is “what is your test article type?”.  For small molecules, invariably there will be two species needed; a rodent and a non-rodent, while for [...]

By | July 9th, 2016|Categories: Homepage Featured, Lessons Learned: Nonclinical Programs|

Lessons Learned in Preparing Nonclinical Programs Part III:

Analytical/Bioanalytical Methods Validated analytical/bioanalytical methods will be required to determine the amount of drug administered to the animals, the amount of circulating drug in the serum/plasma, and the presence of antibodies against the drug [...]

By | July 8th, 2016|Categories: Lessons Learned: Nonclinical Programs|

Lessons Learned in Preparing Nonclinical Programs Part IV:

Administrative Issues Contracts: When outsourcing your work to a CRO, you need to ensure that you are protected from a legal standpoint.  There are two basic contracts that you will need.  The first is [...]

By | July 7th, 2016|Categories: Lessons Learned: Nonclinical Programs|