drug discovery and clinical trials Flashcards
drug discovery initial identification
published research disease knowledge pharmaceutical analysis generating hypotheses traditional or herbal luck metabolites of existing drugs
cellular drug targets
g protein coupled receptor
drugs as selective ligand
cellular drug targets
ion channels
challenging due to pore forming homology
cellular drug targets
transport proteins and enzymes
protein kinases, targets for oncology
genetic associations
GWAS sequencing of whole genomes allows for identification of subgroups requirements for new personalised medicines
high throughput screening target validation
large no. modulators against drug candidate to rapidly exclude those with poor response
bioinformatics
analyse data sets to show targets and understand disease processes to identify drug targets
Pre
pharmacodynamics PD
what drug does to the body
Pre
pharmacokinetics PK
what body does to the drug
Pre
basics of PRECLINICAL study
animal models no humans PK PD safety and toxicological investigations pharmaceutical development-large scale feasibility
Pre
pharmacodynamics research
site/mechanism of action
influence of age sex and other factors
dose-response
Pre
pharmacokinetics research
absorption- rate and bioavailability
distribution in tissues
metabolisms - accumulation and interactions
excretion- clearance and organ
Pre
safety and toxicological
adverse effects non toxic dose therapeutic range post mortem for tissue damage intra and inter species variability
Pre
pharmaceutical development
formation and administration
large scale synthesis/purification feasibility
compound stability under different conditions
when can Pre go to clinical
once thorough and comprehensive preclinical satisfied a regulatory body for safety and efficacy can move on to human testing