maliqun61 schreef op 11 maart 2021 13:33:
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Bedankt Bassie
Dit heb ik na vluchtige lezing eruit gepikt:
PreclinicalBasic research Drug discovery Preclinical research Average duration: 1-6 years
Phase 1Typically enrolling 20-100 volunteers or mildly affected patients Measures safety and investigates possible side effects of treatment Average duration: Typically up to 1 year
Phase 2Approximately 70% of all new drug research reaches Phase 2 Typically involves several hundred patients with varying levels of disease severity. Measures the effectiveness of the drug and checks for side effects Average Duration: Several Months to 2 years
Phase 3Approximately 33% of new drug research reaches Phase 3 Tests the largest number of patients possible (in relation to the disease size) Average Duration: 1 – 4 years
Approval & commercialisationOnly 25 to 30% of treatments are approved. After completing Phase 3 a pharmaceutical company can move forward with a New Drug Application (NDA) or a BLA in the US and a marketing authorisation approval (MAA) in the EU Total Average Duration: 6 – 7 years
Variation in this trajectory:
• Orphan/rare disease
• Product availability
• New drug or a new indication for an existing drug