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WorksheetsTopic 1 ECH4204
Total questions: 50
Worksheet time: 25mins
GMP (Goods Manufacturing Practices) outlines a quality approach to the following:
Select all that apply
a) Labelling
b) Packaging
c) Manufacturing
d) Storage and Distribution (Shipping of Drugs)
All of the above
a, b and c
b,c and d
a and c
The Quality Mindset involves Accountability, and as a Roche employee that means:
Select all that apply
a) Always checking my work
b) Never make a mistake
c) Following valid processes
All of the above
a and b
a and c
b and c
Several tragedies in the early 20th century lead to which change(s) in how drugs are made available to the public?
Select all that apply
a) Requirement to provide expiry dates
b) Requirement for proof of effectiveness
c) Requirement for regulatory approval / authorization
d) Requirement for safety studies
All of the above
a, b and c
b,c and d
a and c
Good Manufacturing Practices were first formalized in the…
1890s
1920s
1960s
1990s
In a GMP organization, production and quality assurance functions are headed by the same manager.
True
False
sometimes
Which of the below does not require halal certificate?
Cosmetics
Pharmaceutical
Water filter
Machine
What is guaranteed about the quality of medicines?
The prescription of medical products for cancer treatment
The promotion of advertising campaign for the development of herbal medicines
The enhancement and promotion of the standards of the development, production, and distribution of medicines
The enhancement and fostering of pharmaceutical image in medicine production
Research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention
Pharmacogenetics
Nanomedicine
Precision medicine
Clinical Trial
After the trial ends, the drug company submits all of its data this this organization so that the drug can move to market.
IRB
FDA
IRS
NIH
Treatment that uses certain parts of a person's immune system to fight diseases such as cancer
Nanomedicine
SNP
Immunotherapy
Precision medicine
This phase of a clinical trial is tested on fewer than 100 people, and is used to determine safety and dosage.
Phase I
Phase II
Phase III
Phase VI
Monoclonal antibodies, interferons, and interleukins are types of these:
Clinical trials
Placebos
Drugs
Immunotherapies
A drug that slows down body functioning.
Stimulant
Depresssant
None of the choices
A drug that speeds up the activity of the body and the brain.
Stimulant
Depressant
none of the choices
Alcohol is a depressant that slows down body functions such as movement, speech, reaction time and thinking ability.
True
False
What is pharmacokinetics?
The study of how the body reacts to the presence of a drug
The study of how drugs interact with each other
The study of how drugs affect the environment
The study of how drugs are synthesized in the laboratory
Parenteral route of drug administration is via
skin
oral
subcutaneous
lungs
Most medicines are made up of the active pharmaceutical ingredient (API) and various excipients. Which one of the following is NOT a possible justification for formulating medicines in this way?
The excipients stabilise the API so that it does not degrade appreciably before administration
The excipients reduce the possibility of the API irritating the body
The API and the excipients each exert a pharmacological effect
The API is too potent to use undiluted
Which of the following provides the best definition of pharmaceutics?
It is the study of the effect that drugs have on the body
It is the study of the effect that the body has on drugs
It is the study of dosage form design, including associated manufacturing techniques
It is the study of how drugs can be chemically synthesised
What does the D in ADME stand for?
Destruction
Distribution
depression
dissolution
Which one of the following is not a route of administration?
IV
Topical
Dissolution
oral
A rectal suppository is used to treat a fever. This would represent what type of drug delivery?
Parenteral and local
Parenteral and systemic
Enteral and local
Enteral and systemic
Which one of the following medicines does not rely on topical drug delivery?
nasal spray
anti-dandruff shampoo
insulin pen
nicotine patch
Which one of the following is not a common dosage form for fentanyl?
vaporizer
Lollipop
transdermal patch
IV infusion
Which one of the following is an example of the chemical modification of an active pharmaceutical ingredient?
Combining a basic API with citric acid to produce the citrate salt of the API
Mixing a poorly soluble API with water to produce a suspension
Converting a crystalline API into an amorphous form
Mixing a soluble API with water to produce a solutio
Express 50 mg in kg.
5 x 10-3 kg
5 x 10-4 kg
5 x 10-5 kg
5 x 10-6 kg
A volume of 10 dm3 may also be expressed as which one of the following?
1 x 10-3 L
10 L
0.1 m3
0.001 m3
Which department starts the investigation upon receiving Complaints?
Production
Quality Control
Quality Assurance
Marketing and Promotion
__________________ is the period of time over which a product is developed, brought to market and, finally, removed from the market.
life cycle
product cycle
product life cycle
Product cycle
_______________ is an investigative activity that a business choose to conduct, with the intention of making a discovery that can lead to either the development of new products or process, or the improvement of existing products or process.
Research and Development
Research and Survey
Marketing Survey
Survey and Investigate
In order to avoid confusion over the various names given to drugs, many hospitals are now using which of the following drug names, which is the most common name and is recognized all over the world?
trade name
chemical name
proprietary name
generic name
Ethyl 1-methyl-4-phenyl isonipecotate hydrochloride is an example of which of the following drug names?
trade name
generic name
proprietary name
chemical name
After giving the drug, you notice the patient’s condition has improved. What is this effect named?
Expected side effect
placebo effect
favorable effect
therapeutic effect
What does the black box warning on the inset of the drug packaging indicate?
The drug is highly addictive, and most patients will be at a higher risk for dependency
The drug has a higher-than-normal risk for causing serious and even life-threatening problems
The drug is experimental, and unusual reactions may occur in many patients
The drug has been packaged in another country and may be contaminated
Which of the following drugs has the quicker onset of action?
sublingual
buccal
Beta Blockers (such metoprolol) is an example of __________.
Cardiovascular / Antiarrhythmics Agents
Anti-diabetic Agents
Anti-inflammatory Agent
Agent for depression / sedation
Which drug route is administered by injection?
oral
instillation
subligual
parenteral
