Safety Portfolio of Rosiglitazone Drug

Safety Portfolio of Rosiglitazone Drug Preparing a portfolio of studies (involving summary paragraphs and tables) evaluating the efficacy/safety of a marketed drug NAME OF DRUG IS ROSIGLITAZONE at different stages (- In vitro testing cell lines & ex vivo preparations -? Testing in animals -? Clinical trials & Post marketing safety data.) of its development. requirements -Section 1 - Introduction to ROSIGLITAZONE drug (focusing on background, Mod of action of ROSIGLITAZONE what is used for, etc.) (500 words max) -?Section 2 – In vitro toxicity -? A summary table of the in vitro toxicity literature (max 5-10 references) -? A 500 word (max) summary of the in vitro toxicity literature -?Section 3 – Toxicity in Animal Models -? A summary table of the animal toxicity literature (max 5-10 references) -? A 500 word (max) summary of the animal toxicity literature –Section 4 – Clinical Safety Testing -? A summary table of the clinical safety literature including (study Details (design – patients- duration) -Criteria – interventions – assessment - toxicity (adverse effect) -Reference) (max 5-10 references) -? A 500 word (max) summary of the clinical safety literature -Section 5 – Overall Summary - An overall 1000 word (max) summary on the safety of your drug and expressing your opinion. You have to take this points in to consideration -Define ‘toxicity’ – what are you actually measuring? ?- Measurable System - What can you measure? - Qualitative assessment - Mood/Feelings/Personality - Quality of life/improvement of symptoms -Trial Design (• Most trials involve “between-patient” comparisons – each patient receives only one treatment. •? Cross-over trial uses “within-patient” comparisons – each patient receives more than one treatment. •? Multicentre: Trial run in more than one location/country/continent. •? Single Blinding, Double Blinding & Triple Blinding – neither the patient, clinician nor the statistician knows what treatment the patient is receiving.)