Preceptor

Ed Gunn
Product Manager

Description

In the schedule II narcotic market place, pharmaceutical companies often utilize pharmakokinetic (PK) studies to support clinical study results. Single and multi-dose PK studies supporting chronic administration of opiate analgesics for the treatment of moderate to severe pain associated with cancer and non-malignant conditions have been used to gain a competitive advantage. Physicians who specialize in pain medicine are constantly detailed on the potential correlation between clinical study results and PK study results.

Roxane Laboratories is currently in the launch phase of a novel sustained release oxycodone product. It is imperative that the RLI field sales force be well versed in the interpretation of PK studies, both single and multi-dose, and the potential correlation between blood levels and potential clinical effects from both an efficacy and safety stand point.

Objectives

1. Develop a basic training module that discusses the basics in pain physiology and key receptors for oxycodone.

2. Included in the module would be definitions of key terms of a PK study, e.g., Cmax, Cmin, Tmax, AUC, etc.

3. Critically analyze and evaluate literature on the mechanism of action and pharmacokinetic characteristics of the novel compound under development and other competitive products.

4. Analyze and evaluate potential correlation of blood levels in patients who experience opioid-induced adverse events.

5. Interpret and combine literature sources into a concise written training presentation.

Requirements and Activities

During the rotation, the resident will be expected to do the following activities:

1. To be present at the site for a minimum of 40 hours per week, or at off-site location as dictated by the nature of the work being completed and agreed upon by the preceptor and the resident.

2. Perform medline and other searches, obtain references and provide drug information/medical support for the compound under development.

3. Interact with internal and external consultants in the pharmaceutical industry to establish a basic understanding of how clinical development of a new drug product is implemented.

4. A weekly review meeting will be held with the preceptor to review the status of the project.

Required Readings

Readings will be supplied to the resident prior to discussions.