PHYSCI 121 Lecture Notes - Lecture 18: Drug Discovery, Clostridium, Human Subject Research
Document Summary
A new drug compound, bruinite sulfate, is identified as a potential therapeutic for dmd. Negative trials are not squelched by pharmaceutical companies. Everything must follow the rules: manufacturing costs (drugs can be made abroad and cost differently based on manufacturing practices. If not, fda can shut down manufacturing plants) The lowest published cost is million for an optimer antibiotic to treat the bacteria, Pre-clinical (lab and animal studies, multiple species or one species might be required before human trials) Clinical trials (phase 1, phase 2 (look at dosing and whether it will work. Fda review (can finally submit to the fda after phases, takes a few years) Screening/early detection: diagnostic, genetic, quality of life/supportive care, observational. Study design: definition: formulation of experimental approach. Safety: dose escalation (1 dose better than the other) Usually in incraments: observational, medical records review (gives ideas about creating new clinical trials) Protocol: definition: clearly written description of the study, components, background, objectives.
