Do you guys still remember how to develop new drugs in I/GCSE Biology?

• In I/GCSE Biology, Disease treating drugs = safe, effective, chemically stable, successfully taken in and removed from body
• All clinical trials are double-blind trials
• Some patients give placebo (dummy medicine), some given actual drug
• Not doctor or patients know what they have received until trail complete
• Drug put through tests before use – trails are:
• Laboratory – Animals or tissues used in lab. Find out level of toxicity + if drug works
• Phase 1 clinical – Low doses tested on small group (health people) to evaluate safety + identify side effects
• Phase 2 clinical – Larger group of people tested to see if effective + further evaluate safety + determine optimum dose
• Phase 3 clinical – Large groups of people tested to confirm effectiveness + monitor side effects
• T – tissues for toxicity
• H – healthy people for side effects
• P – Patient for effectiveness
• D – patients for dose

• 1957 – thalidomide given to women to help them sleep + overcome effects of morning sickness
• In I/GCSE Biology, women gave birth to babies whose limbs weren’t properly formed
• Testing of thalidomide was incomplete – not tested on pregnant animals
• Thalidomide effectively treats leprosy

In I/GCSE Biology,

That's all~

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