Clinical Drug Development and Rationale Quiz

What does the NPRA in Malaysia regulate?

Approval of medicines, medical devices, food, and cosmetics

What is the purpose of an Investigational New Drug (IND) application?

To be filed prior to beginning clinical trials

What is the function of the Investigational New Drug (IND) application according to the FDA?

It contains extensive data on the investigational drug and results of clinical trials

What is the role of the internal review board (IRB) in clinical trials?

Determine whether the study is ethical Signup and view all the answers

What is the purpose of randomisation in clinical trials?

Prevents selection bias and minimizes confounding Signup and view all the answers

What is the purpose of a placebo in a clinical trial?

Acts as an inert substitute for a treatment or intervention Signup and view all the answers

What does blinding refer to in a clinical trial?

Masking the patient and investigator from information about the treatment Signup and view all the answers

What type of blinding involves masking only the patient?

Single blind Signup and view all the answers

What effect does a placebo have on study participants?

Psychosomatic effects brought about by relief of fears, anxiety, or stress because of study participation Signup and view all the answers

Double blind in a clinical trial refers to which level of masking?

The patient and investigator are blind to the treatment information Signup and view all the answers

What is the primary purpose of pre-clinical testing in drug development?

To develop adequate data to support a decision for human trials Signup and view all the answers

Which phase of drug discovery involves the initial synthesis and analysis of a promising pharmaceutical or the development and analysis of a biopharmaceutical produced in living cells?

Lead optimisation Signup and view all the answers

What is one advantage of conducting in vivo experiments in pre-clinical testing?

Monitor the drug side effects on many organs in the body in one experiment Signup and view all the answers

What is a disadvantage of conducting in vitro experiments in pre-clinical testing?

Environment is not exactly same as in the body Signup and view all the answers

What type of data is collected during pre-clinical testing to support a decision for human trials?

Genetic toxicity and pharmacological effects Signup and view all the answers

What issue makes dissecting mechanisms of action difficult in in vivo experiments?

The drug remains in the system for a long period after administration Signup and view all the answers

Which advantage is associated with conducting in vitro experiments in pre-clinical testing?

Ability to control or modify experimental conditions Signup and view all the answers

What type of information can be obtained from conducting in vivo experiments?

Monitoring drug side effects on many organs in the body and determining drug selectivity for different organ systems Signup and view all the answers

What is a challenge associated with in vitro experiments due to the environment not being exactly the same as the human body?

Metabolite could produce a different or not effect/enhanced effect Signup and view all the answers

During which phase of drug discovery is it possible to use several different tissues in isolated tissue bath experiments?

Pharmacological profiling Signup and view all the answers