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(3) Pharmacology > S1L1: General Principles of Pharmacology > Flashcards

S1L1: General Principles of Pharmacology Flashcards

1
Q

The science that is involved in the formulation of drugs. They are also the only ones who are required to release/dispense the drug

A. Pharmacology
B. Pharmacy

A

B. Pharmacy

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2
Q

The study of drugs
A. Pharmacology
B. Pharmacy

A

A. Pharmacology

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3
Q

____ are any substances, molecules, biological mechanisms that can alter the physiologic mechanisms of the body.

A

Drugs

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4
Q

What the body does to the drugs?

A. Pharmacokinetics
B. Pharmacodynamics

A

A. Pharmacokinetics

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5
Q

What the drug does to the body?

A. Pharmacokinetics
B. Pharmacodynamics

A

B. Pharmacodynamics

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6
Q

PHARMACOKINETICS: What do you call the amount of drug that would be in the systemic circulation?

A

Bioavailability

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7
Q

What do you call the distribution of the drug to the other organs?

A

Drug Distribution

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8
Q

True or False: The drug intended for the lungs may also reach the liver, heart, skin, kidneys, etc.

A

True

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9
Q

True or False: While the drug is in the systemic circulation, a part of it is already being cleared slowly.

A

True
(this is known as drug clearance)

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10
Q

Once the drug is at the site of action or the targeted site, what happens now?

A

The drug will exerts its pharmacologic effect.

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11
Q

What are the four (4) components under pharmacologic effect?

A
  1. Clinical Response
  2. Efficacy
  3. Utility
  4. Toxicity
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12
Q

Drug Nomenclature

Determined by the chemical composition/structure

Sometimes too long, too difficult to pronounce, or difficult to remember

A. Chemical Name
B. Generic/Non-proprietary or official name
C. Trade/proprietary or brand name

A

A. Chemical Name

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13
Q

Drug Nomenclature

Derived from the US Adopted Names Council

A. Chemical Name
B. Generic/Non-proprietary or official name
C. Trade/proprietary or brand name

A

B. Generic/Non-proprietary or official name

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14
Q

Drug Nomenclature

Once the drug is owned by a pharmaceutical
company, they will give their own brand name.

A. Chemical Name
B. Generic/Non-proprietary or official name
C. Trade/proprietary or brand name

A

C. Trade/proprietary or brand name

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15
Q

True or False: Pharmaceutical company can give their own brand name and have the rights for 5 years and it is renewable.

A

False. Pharmaceutical company can give their own brand name and have the rights for 10 years and it is renewable. When the drug is marketed, it may have different brand names according to the company.

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16
Q

T/F: It is possible that a known molecule would go under chemical modification

A

True. An example of this is minoxidil wherein it was initially used as an anti-hypertensive but it turned out to have a side effect of hair growth so it was reformulated for baldness (hair growth drug)

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17
Q

What are examples of drugs that are rationally designed based on biologic mechanisms? Give three

A

Rational Drug Design Based on Biologic Mechanisms:
1. Antihistamines - Allergies are caused by histamine release. They looked into it — what are the receptors involved? — and they got into the chemical
2. Antacid - Medicine for patients with hypersecretion to neutralize the pH of gastric juices
3. Chemotherapy - able to understand the process of cancer as it differs among the types of cancer

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18
Q

T/F: Natural Products cannot be used as Drugs/Medications

A

False. Examples of natural products that can be used as drugs/medications are ginger, garlic, lagundi

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19
Q

Who is the final authority in approving drugs in the PH?

A

Food and Drug Administration Philippines

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20
Q

Give at least five (5) examples of brand names of N-ACETYL-P-AMINOPHENOL (CHEMICAL) or PARACETAMOL/ACETAMINOPHEN (GENERIC)

A

● Tempra (Mead Johnson)
● Medicol (United laboratories)
● Opigesic (Roche)
● Biogesic (United Laboratories)
● Gifaril (Zuellig)
● Afebrin (Westmont)
● Alvedon (Astra)
● Pyregesic (Primera)

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21
Q

Give at least five (5) examples of brand names of PHENYLISOPROPYLAMINE (CHEMICAL) or
PHENYLPROPANOLAMINE (GENERIC)

A

● Neozep (United Laboratories)
● Dimetapp (Wyeth)
● Ornex (SKB)
● Sinutab (Warner Lambert)
● Nafarin (UAP)
● Triaminic (Zuellig)
● Rhinopront (Zuellig)
● Nasatapp (Prohealth)

22
Q

T/F: Food Supplements do not need FDA approval

A

True. However, food supplements need FDA registration. FDA will require the following tag to its product and advertisements that it’s not FDA approved: “The supplement has no therapeutic approval/effect. “

Only drugs need BOTH FDA APPROVAL AND REGISTRATION

23
Q

FDA PRECLINICAL SAFETY AND TOXICITY TESTING
Pharmacologic Profile Tests
1. What happens to the cells in the alveoli when this antibiotic is given?
2. Look at the effect of the substance at the this level and look where the substance will go in terms of receptors
3. Test the substance to the disease model

A. Systems/Disease Models
B. Molecular
C. Cellular

A
  1. C
  2. B
  3. A
24
Q

What are the eight (8) elements do you test toxicity (under FDA preclinical safety and toxicity testing)?

A

Acute Toxicity
Subacute Toxicity
Chronic Toxicity
Effect in Reproductive Performance
Teratogenicity
Carcinogenicity
Mutagenicity
Investigative Toxicology

25
Q

T/F: Preclinical Safety and Toxicity testing should not be done in live animals

A

False. “Preclinical” and toxicity testing are both done in live animals.

26
Q

TOXICITY TESTING

  1. 1 dose, 1-2 routes, 2 weeks, 2 species of rats; Compares Routes
  2. Repeated doses, route (that was identified as the ‘best one’), 2 weeks - 2 months, 2 species.
  3. Repeated doses, same rout, 90 days, 2 species
  4. Looks at the next generation offsprings

A. Acute Toxicity
B. Subacute Tocixity
C. Chronic Tocixity
D. Effect in Reproductive Performance
E. Teratogenecity
F. Carcinogenicity
G. Mutagenicity
H. Investigative Toxicology

A
  1. A
  2. B
  3. C
  4. G.
27
Q
  1. Looks at other rare ways that drugs can be toxic
  2. You want to see if the males are no longer interested in the female rats or vice versa, or if the feamle rats stopped ovulating/no sucessful pregnancy, low sperm count for male rats
  3. Allow the lab rats to get pregnant and look at the offsprings in terms of their normalcy
  4. Look at the cells of the surviving rats and identify any cancerous cells

A. Acute Toxicity
B. Subacute Tocixity
C. Chronic Tocixity
D. Effect in Reproductive Performance
E. Teratogenecity
F. Carcinogenicity
G. Mutagenicity
H. Investigative Toxicology

A
  1. H.
  2. D.
  3. E
  4. F
28
Q

Women who took this drug resulted to children with limb defects such as amelia and phocomelia

A

THALIDOMIDE

29
Q

T/F: Thalidomide is both teratogenic & mutagenic

A

True. Immediate offsprings and some next gen offsprings acquired abnormalites or congenital malformations

30
Q
  1. Smallest dose observed to kill any animal
  2. Maximum dose at which the specified toxic effect is not seen
  3. Dose that kills approx 50% of the animals

A. Median Lethal Dose (LD50)
B. Minimum Lethal Dose
C. No Effect Dose

A
  1. B.
  2. C.
  3. A.
31
Q

Drug X tested on 20 rats:

1 mg: 5 rats no spasm
5 mg: 10 rats no spasm
10 mg: 15 rats no spasm, but saw a toxic effect (5 rats are drowsy)
20 mg: 10 rats no spasm; 5 rats drowsy, 5 rats dead
30 mg: 5 rats no spasm; 5 rats drowsy, 10 rats dead

What is the no effect dose?

A

5 mg

32
Q

Drug X tested on 20 rats:

1 mg: 5 rats no spasm
5 mg: 10 rats no spasm
10 mg: 15 rats no spasm, but saw a toxic effect (5 rats are drowsy)
20 mg: 10 rats no spasm; 5 rats drowsy, 5 rats dead
30 mg: 5 rats no spasm; 5 rats drowsy, 10 rats dead

What is the minimum lethal dose?

A

20 mg

33
Q

Drug X tested on 20 rats:

1 mg: 5 rats no spasm
5 mg: 10 rats no spasm
10 mg: 15 rats no spasm, but saw a toxic effect (5 rats are drowsy)
20 mg: 10 rats no spasm; 5 rats drowsy, 5 rats dead
30 mg: 5 rats no spasm; 5 rats drowsy, 10 rats dead

What is the median lethal dose?

A

30 mg

34
Q

T/F: Drug/toxicity testing is not time consuming and is cheap

A

False. One of the limitations of toxicity testing is that it is time consuming and expensive. Drug testing can take up to 3 years and millions of dollars.

35
Q

T/F: Large number of animals needed to obtain preclinical data.

A

True. Usually needs to kill several rats or rabbits

36
Q

T/F: Extrapolation of toxicity from animals to human is completely reliable

A

False. Extrapolation of toxicity from animals to human is not completely reliable. Even if we saw that the drug is not toxic to the animals, once it is used in humans, are we sure that it will not have toxic effects?

37
Q

T/F: Rare adverse effects can be detected in toxicity testing

A

False. Rare adverse effects are unlikely to be detected in toxicity testing

38
Q

Give three (3) reasons why we need to do a clinical/human testing for new drugs?

A
  1. To check if it is really the effect of the drug or just the variable natural history of the diseases
  2. To check for any presence of other diseases and risk factors
  3. To check for any presence of subject and observer bias
39
Q

What is the next step after clinical testing?

A

Investigational New Drug (IND)

40
Q

What are the (5) components that should be seen in IND?

A
  1. Drug Information
  2. Manufacturing Information
  3. Data from animal studies
  4. Clinical plans and protocols
  5. Names and credentials of doctors who will conduct the trials
41
Q

What is the true written informed consent signed before a participation in a drug trial?

A

WORLD MEDICAL ASSOCIATION’S DECLARATION OF
HELSINKI (7TH REVISION, 2013)

True meaning the participant understood what’s going to happen & understood what are the side effects.

42
Q

How many phases are there in clinical/human testing?

A

Five (5) phases

43
Q

PHASES OF CLINICAL/HUMAN TESTING

  1. New addition, some FDA do not require it, some pharmaceuticals, research doctor added it
  2. Exploratory
  3. Drug is already released in the market and is sold in drugstores, being given now in the patients in the hospital
  4. Large number of patients (>1000) with disease or condition
  5. One week; 10 - 20 normal (human) participants

A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. Phase IV

A
  1. A
  2. A
  3. E
  4. D
  5. A
44
Q

PHASES OF CLINICAL/HUMAN TESTING

  1. Subtherapeutic dose and still need to submit results to FDA
  2. Non-blind (meaning that MD knows what pt is receiving and pt knows what the MD is administering)
  3. Double blind, cross over technique
  4. Obligation to report low-incidence side effects seen in patient (especially rare side effects)
  5. Uses insert placebo or older active drug vs. investigated agent

A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. Phase IV

A
  1. A
  2. B
  3. D
  4. E
  5. C
45
Q

PHASES OF CLINICAL/HUMAN TESTING

  1. Usual duration of this phase is 1 - 2 years
  2. Subjects are medium in number (100-1,000) with matched demographics for intended use of drug
  3. Usual duration is several months to 2 years
  4. Performed in settings similar to those anticipated for the ultimate use of the drugs; Often difficult to design, expensive
  5. Usual duration is usually 2 - 3 years
  6. There is no fixed duration

A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. Phase IV

A
  1. B
  2. C
  3. C
  4. D
  5. D
  6. E
46
Q

What are the five (5) objectives of phase 1 of CLINICAL/HUMAN TESTING?

A
  1. Safety
  2. Determine differences between animals and humans
  3. Establish probable limits of clinical dose range (how animals and humans will behave?)
  4. Determine routes - is it best for a certain route? IV, oral, topical?
  5. Determine food effects - reabsorption properties may be affected. Empty stomach for maximum absorption? Full stomach? Will it cause gastritis anddevelop ulcers?
47
Q

T/F: For humans, start with 1/10 to 1/100 of the no effect dose from pre-clinical trials.

A

True

48
Q

PHASES OF CLINICAL/HUMAN TESTING

  1. Results of this phase include safe dose ranges, predicted toxicities, absorption, half life, metabolism of the drug.
  2. Investigators of this phase are research centers and specially trained clinical pharmacologists, MD
  3. Results of this phase include safety, efficacy, routes, dose, schedules
  4. Investigators of this phase are doctors in special clinical centers and multicenters
  5. Investigators of this phase include specialist in the disease to be treated and multi-centers

A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. Phase IV

A
  1. B
  2. B
  3. C
  4. C
  5. D
49
Q

T/F: The objective of phase 2 of clinical/human testing is to determine safety and efficacy

A

True

50
Q

What are the three (3) objectives of phase III of clinical/human testing?

A
  1. Minimize errors caused by placebo effect and variable courses of diseases
  2. Confirmatory for safety and efficacy
  3. Pharmacoeconomics – determine
    cost-effectiveness. What is the best way to
    administer the drug on the patient with less financial burden?
51
Q

TYPES OF DRUGS
1. Another special prescription pad different from the original pad is required
2. Examples of such drug is opioid
3. Require a prescription pad from a doctor which contains the name and license number of the doctor and the name of the patient
4. Example of this type of drug is pain, headache, and flu
5. Does not need a prescription
6. Example of this type of drug is antibiotics and pain medications

A. Prescription/Legend Drugs
B. Non-prescription/Over-the-coutner drugs
C. Regulated drugs/Drugs with abuse potential

A
  1. C
  2. C
  3. A
  4. B
  5. B
  6. A
52
Q

What is the license that is needed for prescribing drugs with abuse potential?

A

S2
■ From the Dangerous Drugs Board
■ Anesthesiologists, Pediatrics (dealing with
seizure disorders), Neuropsychiatrists
■ Drug tests are also required

(3) Pharmacology (12 decks)

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