Summary
Samenvatting preklinische toxicologie
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Dit is een samenvatting van het gastcollege over preklinische toxicologie
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Nessie81
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Early non-clinical safety testing(Feyen)
Toxicity safety profile
o Rodent en non-rodent (softenon)
o Minstens even lang doseren als in klinische trial
o Klinische administratieroute gebruiken indien mogelijk
o Dieren (farmacologie/toxicologie/kinetiek) gezonde vrijwilligers (tolerantie/AEs)
patiënten (efficaciteit/dosis/veiligheid)
o Fase 2: patiënten
Proof of concept (POC)
Optimale dosis
Veiligheidsprofiel
o Fase 3: grote patiëntenstudies
Verschillende groepen binnen populatie
Meerdere indicaties
Reproduceerbaarheid van resultaten
Veiligheidsprofiel na kort en langdurig gebruik
GM specificiteit, AEs en veiligheidsmarge > andere GM
Studies tijdens alle fasen
o Tolerantiestudies (DD)
Niet verplicht
Rodent en non-rodent
Repeated dose
Doel
MTD (max tolerated dose) of MFD (max feasible dose, beperkt door
oplosbaarheid/formulatie/max toegediende volume)
Target organen of algemene toxiciteit
Toxicokinetiek
Dosissen voor GLP studies bepalen
o Fase 1: FIH (ED)
Verplicht
GLP studies GO (FIH)/NO GO (stop project)
1m + 1m repeated dose studies (rodent en non-rodent)
Safety pharmacology studies
Genotoxicity studies
o Fase 2A: POC (ED)
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