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.)
