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Onko (Subject) / 2. Steurer (Lesson)
- What is the main goal of a phase I clinical trial? understanding of the biological characteristicas of a new molecule/proteinfirst introduction of new drugs into human(small group)done in healthy subjectsdetermining of absorbtion, distribution, metabolism and excretiontoxicity check, preelminary safety screeningduration 6-months
- What is the main goal of a phase II clinical trial? Dose, Schedule, and Clinical Proof of Concept:Preliminary efficacy finding in patients with targeted disease. Assess short term safety, side effects, therapeutic dose-range finding Determine short-term side effects & risks associated with the investigational product 6 months - 2 years duration Support/justify registration of the new product study population and control mirrors, preperation for phase 3
- What is the main goal of a phase III clinical trial? - comparison against established therapies to demonstrate short/long term and safety and efficacy. Moreover forming the core of marketing license application- provide basis for product labeling ( which disease, side effects)- 500-5000 patients
- What is the main goal of a phase IV clinical trial? Post approval Goals: gain additional experience within labelled indications to better understand drug/disease obtaining more information on safety, pharmacoeconomics, quality of life, market support
- What does the declaration of Helsinki regulate? - establishe ethical principles for medical research- informed consent must be documented- the patients right for safety, wellbeing and privacy comes first
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