Incorporating basic information on disease incidence and prevalence, unmet medical need and present treatment guidelines (highlighting regional variations where appropriate).
Overview of the market: What are the unmet needs of currently available therapies?
Which competitor compounds/classes of compounds are in the clinic/late development?
Introduction to the drug:
Pharmacokinetics and metabolism
(Phase I studies)
Phase II studies
Summary table of Phase I and II trial results
Phase III studies
Summary table of Phase III trial results
Safety and tolerability, including a table summarizing safety outcomes in clinical trials, and a table comparing the characteristics of the drug with its competitors.
Include information on the status of the drug, i.e., where it is currently approved, in which countries it is approved and for what indications. This should cover Europe, US and rest of the world where appropriate.
An analysis of the data presented in the review.