safety testing of new drugs Flashcards
What is a clinical trial and what does it test for?
An experiment conducted on humans
Test for safety and efficacy as well as quality for pharmaceutical companies
What are some of the reasons for failure in clinical trials?
- poor safety
- poor efficacy
Clinical trial application - risks are anticipated with safety study of drug in animal. TRUE OR FALSE?
TRUE
What are basic safety tests designed to do?
- Relate toxicity to exposure
- Gain understanding of organs that may be target of toxicity
- Estimate therapeutic window
- assess reversibility of toxicity
- Predict pharmacokinetics and pharmacodynamics effects in humans
What are the outcomes for basic safety testing?
- develope a dose for clinical trials
- Watch out for certain ADRs and monitor them
What does ICH stand for and what do they do?
International conference of harmonization
they approve non-clinical safety testing
What does toxicokinetics data provide?
-provides context (exposure) for toxicity data and bridges between animal data and human data
what are some of the aims of GLP?
- QA
- SOP
- test systems
- equipments are calibrated correctly
- reporting of study results
What is safety testing of pharmacology and which systems are investigated?
-investigations of undesirable pharmacodynamic effects
CNS, cardiovascular system and respiratory system
What is assesed in reproductive toxicity?
-fertility, embryonic and fetal development, teratogenicity
Genotoxicity are usually in vitro studies. TRUE OR FALSE?
TRUE
What does the ames test rely on?
on mutant salmonella strains
if mutant salmonella strains are grown in the absence of histidine, then no bactrial growth is observed but in the presence of histidine bacterial growth is observed. TRUE OR FALSE?
TRUE
How are chromosomal abberations and aneuploidy tested?
- chromosome abberation assays
- micronucleus assay
What are carcinogenetic test tell us?
carcinogenetic effects tells us about mutagenic effects in animal which is also similar to humans
what are the four phases of clinical trials and describe what occurs in ecah stage
Phase 1: 25-50 patients in healthy volunteers (safety, tolerance/PK/PD
Phase 2: 25-200 patients (efficacy and safety, identifies doses for phase 3, explores on PD effects
Phase 3: 250-3000 patients (safety, efficacy compare to competitors/ common ADRs
-MARKETING APPROVAL
Phase 4: less commmon ADRs
Pharmacovigilance
what are single and multiple ascending dose phase in phase 1 clinical trials?
Single ascending dose - small cohort takes single dose of drug
Multiple ascending dose - small cohort takes multiple doses of drug
Rare ADRs are only picked up once drug has been approved and is on the market. TRUE OR FALSE?
TRUE
For new diabetes drug, they need to prove that they have do not cause C.V harm. TRUE OR FALSE?
TRUE
Why aren’t teratogenicity effects discovered in clinical trials?
-pregnant women are excluded in trials, much reliance on animal data
