Lessons Learned: Nonclinical Programs

//Lessons Learned: Nonclinical Programs

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 design process. Have in-depth discussions about the structure, class, intended use, mechanism of action, previous findings, and anything else that may affect […]

By | 2017-07-04T10:26:21+00:00 July 10th, 2016|Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part I:

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 a biopharmaceutical it could be either one species or two species. While there is public pressure to minimize the use of species […]

By | 2017-07-04T10:26:25+00:00 July 9th, 2016|Homepage Featured, Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part II:

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 (applies only to biopharmaceuticals) in the serum.  Depending on your project, you may also need analytical methods for other matrices such as […]

By | 2017-07-04T10:26:27+00:00 July 8th, 2016|Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part III:

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 a confidentiality contract (also called a CDA or NDA), which will protect any conversations you have with the CRO as being privileged […]

By | 2017-07-04T10:26:32+00:00 July 7th, 2016|Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part IV: