Animals in drug development Flashcards
1
Q
What preclinical studies are needed to support the development of a drug?
A
Studies that address.
- rationale (the theory of the cure)
- safety (toxicology studies)
2
Q
What do you look at in rationale studies?
A
- 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
3
Q
What should preclinical safety studies do to support early clinical trials?
A
- identifiy an initial safe dose
- identify potential target organs for tox
- identifiy safety parameters for clinical monitoring
4
Q
What should preclinical safety studies address to support late clinical trials/marketing approval?
A
- effect of prolonged (chronic) exposure
- genotoxicity/carcinogenicity
- reproductive toxicity
5
Q
Types of safety studies
A
- safety pharmacology
- general tox
- genotox
- reprotox
- phototox
- local tolerance
- immunotox
- carcinogenicity studies
6
Q
Which are the organs tested in high single dose toxicity studies?
A
- CNS
- cardiovascular
- respiratory
7
Q
Which kinds of immunotoxicity findings may trigger designated studies?
A
- hematological changes
- alterations in immune system organs
- changes in serum globulins
- infections
- tumours
8
Q
What are exploratory clincal trials?
A
- 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)
