Safety Portfolio of Rosiglitazone DrugPreparing a portfolio of studies (involving summary paragraphs and tables) evaluating the efficacy/safety of a marketed drug NAME OF DRUG IS ROSIGLITAZONEat 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.)