Select the incorrect statement below?
- a) Phase 1 trial determines whether the treatment is dangerous, usually for healthy participants
- b) Phase 2 determines whether the treatment’s efficacy, usually in patients who have the disease being treated
- c) Phase 3 is usually a very large trial to determine whether the treatment has greater efficacy then other treatments on the market
- d) Phase 4 determines whether the treatment is able to treat other diseases or monitoring in larger sample, but is after the drug has been approved
Preclinical studies often involve:
- a) determination of a drugs PK properties, PD properties, clearance rate and safe dosage
- b) In vitro but not in vivo testing
- c) Single-dose toxicity but not repeat dose toxicity
- d) Efficacy studies but only in extremely sick animals
When conducting a clinical study, which of the following ethical considerations are not always required.
- a) Human consent where applicable according to the declaration of Helensinki
- b) Animal ethics approval from AEC
- c) TGA approval for the study
- d) HREC approval for the study
Which of the following did cause a medical emergency due to shortfalls in drug approval?
- a) Sulfanilamide
- b) Thalidomide
- c) Aspirin
- d) Benzodiazepams
One of the four studies are not necessary for a genotoxicity study, which one of the following is it?
- a) Rate haemopoietic in vivo genoticity studies
- b) Repeat dose for rat mutations
- c) Chromosomal cytogenetic test
- d) Ames test
A study has 33 participants who all have cancer, different dosages of the anticancer drug are given to the patients. What phase of the drug testing pipeline is this?
- a) Phase I
- b) Phase II
- c) Phase III
- d) Preclinical
Select the false statement below
- a) Drug discovery involves finding lead compounds
- b) Development of a new drug involves clinical trials
- c) Preclinical pharmacology and toxicology are apart of the development phase
- d) Regulatory bodies are only involved in the final stage of drug development
Anti-sense Oligonucleotide Studies
- a) Can not be approved
- b) Denature the DNA which contains the coding strand for defective protein
- c) Is a type of precision medicine so has no off target effects
- d) Has potential off target hybridisation effects
Which of the following isn’t one of the three r’s of animal ethics.
- a) Reduce
- b) Refine
- c) Replace
- d) Reuse
Multiple drug candidates appear to be promising for treating a novel disease, which candidate would you select
- a) The drug has a small IC50 for it’s kinase, but it also has a large IC50 for many other minor kinase molecules.
- b) The drug has a large IC50 for it’s kinase, but it also has a small IC50 for many other major kinase molecules.
- c) The drug has a small IC50 for it’s kinase, but it also has a large IC50 for many other major kinase molecules.
- d) The drug has a large IC50 for it’s kinase, but it also has a small IC50 for many other major kinase molecules.
- C – can be to determine if it is safer or few side effects then existing treatment
- C, TGA approval is required once the drug is about to go out to the market during the clinical phase researches get HREC’s approval and are required to report to the TGA throughout study
- B – Thalidomide resulted in many birth defects when taken whilst pregnant. The sulfanilamide disaster was a result of the solvent, diethylene glycol