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Flashcards in Animals in drug development Deck (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)