Question

A middle aged patient arrives to your clinic and complains about pain in the abdomen, nausea and having dark stools. You prescribe, Nexium*, thinking this patient is simply suffering from heartburn, but the patient's symptoms remain. You reanalyze the situation, received biopsy results and concluded that this patient is actually suffering from esophageal cancer**. This patient adamantly refuses to undergo of chemotherapy, but is willing to participate in any clinical trials that arise. You have recently read a paper discussing an oral proteasome inhibitor that has presented strong signs in inhibiting the growth for multiple myeloma in vitro models. However, this paper outlines that there are many safety and efficacy issues in targeting the proteasome. While you think the overall mechanism seen in this paper is great and could theoretically treat esophageal cancer, you think targeting the malignant cell’s mitochondria would be safer than targeting the proteasome. Outline a series of steps, from in vivo to clinical trials, to test your proposed theory.

Answer 1

pre clinical phase- testing of drug on non human subjects, to gather efficiency, toxicity and, pharmacokinetic information.

phase zero- pharmacokinetic particularly oral bio availability, and half-life of the drug.

Phase 1- testing of drugs on healthy volunteers for dose ranging.

Phase 2- testing of drugs on patients to assess efficacy and side effects.

Phase 3- testing of drugs on patience to assess effectiveness, efficacy and safety.

phase 4- post marketing surveillance.