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BI training > Intro. to Pharma. > Flashcards

Intro. to Pharma. Flashcards

1
Q

What is the top selling drug in the world right now?

A

Lipitor: anti cholesterol by Pfizer

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2
Q

What is BI ranked globally among others in the pharmaceutical industry?

A

15th

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3
Q

How much does the Australian pharmaceutical industry represent in the global market?

A

1%

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4
Q

Which company in Australia is the top supplier to PBS?

A

Pfizer -> Astra Zeneca -> Novartis

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5
Q

In what year did BI begin?

A

1885

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6
Q

What anniversary did BI celebrate in 2010?

A

125

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7
Q

List 3 main business areas for BI in Australia?

A

Prescription medicine, Consumer health, Animal health

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8
Q

How many potential compounds need to be screened to have 1 pharmaceutical successfully reach market?

A

5,000-10,000 potential compounds will result in 5 tested in clinical trials, and 1 of these will make it to market

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9
Q

How long does new research and development of new medicine take?

A

10-15 years

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10
Q

What is the standard patent for new pharmaceuticals in Australia?

A

20 years

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11
Q

What is a generic drug?

A

When a drug patent expires, other company can produce the same drug compound under other brand names.

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12
Q

Why are product patents so important?

A

It allows the company that discover the molecule to have exclusive right to produce the compound during its time of patent. Therefore allow it to re-coup the R&D cost for discovering the molecule.

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13
Q

Which body is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products?

A

TGA: the therapeutical goods administration

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14
Q

What are the schedules common for pharmaceutical industry?

A

S2: pharmacy medication
S3: over the counter medication
S4: prescription medication

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15
Q

What is the PBS? What does the existence of the PBS mean for patients?

A

PBS: pharmaceutical benefit scheme
PBS ensures all australian residents as well as eligible temporary residents to have access to necessary and live saving medicine and at an affordable price.

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16
Q

What is dispensing price consists of?

A
  • The manufacturers price (as negotiated by the government and the supplier)
  • The whole sale mark up
  • The pharmacy mark up
  • Dispensing fees
  • Any other fees to which the pharmacist is entitled to under the Pharmaceutical Benefits Remuneration Tribunal determination
17
Q

What is Generic Substitution?

A

In 1994, national health act allow the pharmacists to substitute a brand name medication to its generic medication equivalent.

18
Q

What is Brand Price Premium?

A

When there’s more than 1 brand of the same drug, PBS will subsidize to the lowest price, the difference between the brand name medication to that of the PBS subsidize is the brand price premium.

19
Q

What is Therapeutic Group Price Premium?

A

It applies to a group of drugs that have similar safety profile and treatment outcome.
All drugs in this group is deemed to be interchangeable.
Government will subsidize to the lowest price drug in this group.
TGP is the difference between brand drug price to that of the lowest government subsidized price.

20
Q

Outline how drugs produce an effect within the body?

A

Drugs product an effect in the body through its interactions with enzymes and receptors.
This is achieved through either stimulating or inhibiting functions of various cells.

21
Q

List four targets of the drug actions:

A
  • Enzyme
  • Receptors
  • Ion Channels
  • Carriers
22
Q

What is a reception antagonist ?

A

Receptor antagonist block receptors and effects of endogenous compounds

23
Q

What is an enzyme ?

A

Type of protein that catalyze the chemical reaction of other substances without altering its own state.

24
Q

What are side effects and how may they be caused?

A

Side effects are the undesired effect from medication.

This may or may not result from the mechanist of the medication.

25
Q

What is the difference between Pharmacodynamics and Pharmacokinetics?

A

Pharmacodynamics: what the drug does to the body. Through medication acting on: enzymes, ion channels, receptors, carriers.

Pharmacokinetics: what the body does to the drug. Absorption, distribution, metabolism, excretion.

26
Q

What are the main components of pharmacokinetics?

A

Absorption
Distribution
Metabolism
Excretion

27
Q

What are the different routes of drug administration?

A
  • Oral
  • Parenteral
  • Transdermal
  • Inhalation
28
Q

Where does majority of the drug metabolism occur?

A

Liver

29
Q

List two most important pathway for drug excretion in the body:

A

Kidney-> Urine

Bile duct -> small intestine -> Faeces

30
Q

What is the definition of half life of a drug?

A

The time takes for the concentration of the drug in the blood to reduce by half.

31
Q

What are some general components in a clinical trial?

A
  • Introduction
  • Method
  • Result
  • Analysis
  • Discussion
32
Q

Clinical I trial

A

First administration to humans, usually a small number of healthy volunteers
Established the safety of the medicine, how it works and how well it is tolerated.
Identify preferred routes of administration (tablet, liquid, injection) and help determine doses.
Usually in centre with specialized monitoring and surveillance.

33
Q

Clinical II trial

A

First trial of medicine in patients suffering from the condition for which the medicine is intended.
Determine effectiveness and safety.
Small number of patients and conducted by researchers regarded as specialists in the particular disease or condition.

34
Q

Clinical III trial

A

Involve greater number of patients.
Determine whether the medicine confers clinical benefit in the disease for which effectiveness was demonstrated in Phase II clinical trials.
Determine the nature and likelihood of side effects.
Phase III is undertaken when Phase II determines the benefits outweighs the hazards.

35
Q

Clinical IV trial

A

Undertaken after the medicine has been approved for the treatment of a particular disease.
Compare new medication to a wider range of existing medicines/therapies.
Best to establish where the new medicine is best used.
Further investigate of use of medicine in clinical setting including post market surveillance studies.

36
Q

Double blind trial

A

When neither the patient nor the doctor administering the drug knows which treatment is being given.

37
Q

What type of study is considered to be the best method for providing evidence of efficacy?

A

Randomized controlled trials (RCTs)

38
Q

What P-value is considered statistically significant?

A

P<=0.05

39
Q

What does 95% CI mean?

A

95% certain that similar result will occur if the experiment to be repeated.

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