The question is:
For a typical small molecule drug, say mw = 500, which is being developed for the symptomatic treatment of osteoarthrosis:
i. Describe the pharmacological evidence that would be needed to justify clinical development;
ii. Describe the incremental toxicological studies and data that would be needed to support:
– A single ascending dose first-in-human study;
– A multiple ascending dose clinical study;
– A 6-month phase 2 study
– Two one-year phase 3 studies
– Marketing approval
In the case of the single ascending dose study, propose the dose sizes that you would use, given that a NOEL in the most sensitive species was 10 mg/kg.
The question has two parts;
Only the pharmacological evidence to justify clinical development plan that the writer needs to find in some journals about animal model study to demonstrate the efficacy of OA medication.
the good references are Emea 2009,2012…
the second one question purpose just to test you whether you really know the differences between toxicological studies needed in each step
For example if just for phase 1 study, what are needed? Phase 2 study, what else needed? Up until before marketing, what are needed?
So you know what to do in each step so you dont waste energy money to do what dont need to be done for each step.
That means there are a specific toxicological studies in each one phase and fhe question asks to write about them, actually there same but have minor differences.