You are a Clinical Research Director of a small pharmaceutical research company. The CEO has asked for a presentation to the Board about the possibility of developing a new anti-inflammatory analgesic. The discovery group has a candidate molecule with positive animal pharmacodynamics in three different animal models of arthritis (carrageenan, silica, hydralazine), and three models of pain (rat tail flick, skin prick guinea pig, and rat paw pressure). The candidate is not an inhibitor of cyclo-oxygenase 2 (COX-2), and is not chemically related to any other currently-approved non-steroidal anti-inflammatory drug (NSAID). This candidate has molecular weight 487 Daltons, and is readily absorbed as an oral formulation in dogs and rats. Gastric erosions were seen in the rat at doses > 200 mg/kg, which was 30-fold higher than the doses effective in the pain and arthritis models. Elevations in blood urea nitrogen (BUN) were seen in both dog and rat at doses > 4-fold higher than those effective in the pain and arthritis models. Overall, in 14-day toxicology, the most sensitive species appears to be the dog, and the NOEL is 10 mg/kg. There have been no QT prolongations observed, and the hERG channel test was negative to beyond 1 mM.
Describe how you would select an indication for clinical trial development and provide a target product profile in tabular form. Put together an outline clinical development plan using a cartoon to describe the chronology of the clinical phase 1, phase 2, and phase 3 studies. Presuming safe passage in clinical phase 1 (stating any reasonable assumptions that you would make), provide a detailed study design for the phase 2a study, including how you chose dose size / frequency / interval, study endpoints, statistical plan and a power calculation.
It will be submitted through turnitin so please avoid plagiarism.
Maximum words 1500 ( words in tables are not included ).
I have an answered example for it.
I need it before 13/12/2017
December 31, 2017
I am willing to pay higher rates for the most experienced freelancers