Animals in drug development
No description yet. This curated deck is ready for daily study.
Card preview (8)
What preclinical studies are needed to support the development of a drug?
Studies that address. • rationale (the theory of the cure) • safety (toxicology studies)
What do you look at in rationale studies?
• fundamentals • target binding (in vitro) • pharmacodynamic models • disease models • in vivo markers • quantitative aspects • at what concentration is full effect reached? • activity in relation to reference substances
What should preclinical safety studies do to support early clinical trials?
• identifiy an initial safe dose • identify potential target organs for tox • identifiy safety parameters for clinical monitoring
What should preclinical safety studies address to support late clinical trials/marketing approval?
• effect of prolonged (chronic) exposure • genotoxicity/carcinogenicity • reproductive toxicity
Types of safety studies
• safety pharmacology • general tox • genotox • reprotox • phototox • local tolerance • immunotox • carcinogenicity studies
Which are the organs tested in high single dose toxicity studies?
• CNS • cardiovascular • respiratory
Which kinds of immunotoxicity findings may trigger designated studies?
• hematological changes • alterations in immune system organs • changes in serum globulins • infections • tumours
What are exploratory clincal trials?
• limited clinical studies • microdoses • limited single dose in pharmacologic range • limited repeated exposure (max 14 days) • limited preclinical needs • limited genetic toxciology (always Ames) • limited preclinical dosing (dose and duration)