safety testing of new drugs

Question 1

What is a clinical trial and what does it test for?

Answer 1

An experiment conducted on humans

Test for safety and efficacy as well as quality for pharmaceutical companies

Question 2

What are some of the reasons for failure in clinical trials?

Answer 2

• poor safety

- poor efficacy

Question 3

Clinical trial application - risks are anticipated with safety study of drug in animal. TRUE OR FALSE?

Answer 3

TRUE

Question 4

What are basic safety tests designed to do?

Answer 4

• 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

Question 5

What are the outcomes for basic safety testing?

Answer 5

• develope a dose for clinical trials

- Watch out for certain ADRs and monitor them

Question 6

What does ICH stand for and what do they do?

Answer 6

International conference of harmonization

they approve non-clinical safety testing

Question 7

What does toxicokinetics data provide?

Answer 7

-provides context (exposure) for toxicity data and bridges between animal data and human data

Question 8

what are some of the aims of GLP?

Answer 8

• QA
• SOP
• test systems
• equipments are calibrated correctly
• reporting of study results

Question 9

What is safety testing of pharmacology and which systems are investigated?

Answer 9

-investigations of undesirable pharmacodynamic effects

CNS, cardiovascular system and respiratory system

Question 10

What is assesed in reproductive toxicity?

Answer 10

-fertility, embryonic and fetal development, teratogenicity

Question 11

Genotoxicity are usually in vitro studies. TRUE OR FALSE?

Answer 11

TRUE

Question 12

What does the ames test rely on?

Answer 12

on mutant salmonella strains

Question 13

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?

Answer 13

TRUE

Question 14

How are chromosomal abberations and aneuploidy tested?

Answer 14

• chromosome abberation assays

- micronucleus assay

Question 15

What are carcinogenetic test tell us?

Answer 15

carcinogenetic effects tells us about mutagenic effects in animal which is also similar to humans

Question 16

what are the four phases of clinical trials and describe what occurs in ecah stage

Answer 16

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

Question 17

what are single and multiple ascending dose phase in phase 1 clinical trials?

Answer 17

Single ascending dose - small cohort takes single dose of drug
Multiple ascending dose - small cohort takes multiple doses of drug

Question 18

Rare ADRs are only picked up once drug has been approved and is on the market. TRUE OR FALSE?

Answer 18

TRUE

Question 19

For new diabetes drug, they need to prove that they have do not cause C.V harm. TRUE OR FALSE?

Answer 19

TRUE

Question 20

Why aren’t teratogenicity effects discovered in clinical trials?

Answer 20

-pregnant women are excluded in trials, much reliance on animal data