LE1

Question 1

Which type of drug reaction appears irrespective of the dose given and is not predicted from the drug’s known mechanism?

A. Idiosyncratic reaction
B. Dose-dependent reaction
C. Allergic reaction
D. Toxic reaction
E. Side effect

Answer 1

A. Idiosyncratic reaction

Rationale: Idiosyncratic reactions are unusual and unpredictable responses to a drug that occur irrespective of the dose and are not related to the drug’s pharmacological action or mechanism.

Question 2

The Ames test is a method for detecting:

A. Teratogenesis in primates
B. Mutagenesis in bacteria
C. Teratogenesis in any mammalian species
D. Carcinogenesis in primates
E. Carcinogenesis in rodents

Answer 2

B. Mutagenesis in bacteria

Rationale: The Ames test uses bacteria to test whether a given chemical can cause mutations in the DNA, indicating its potential mutagenicity.

Question 3

Biotransformation of drugs is primarily directed to:

A. Convert non-lipid soluble drugs into lipid soluble metabolites
B. Convert lipid soluble drugs into non-lipid soluble metabolites
C. Activate the drug
D. Inactivate the drug

Answer 3

B. Convert lipid soluble drugs into non-lipid soluble metabolites

Rationale: The primary goal of biotransformation (metabolism) is to convert lipid-soluble drugs into more water-soluble (non-lipid soluble) metabolites that can be easily excreted from the body.

Question 4

All these are needed to formulate a research question, EXCEPT:

A. Exposure
B. Sample size
C. Population
D. Outcome

Answer 4

B. Sample size

Rationale: Formulating a research question involves defining the exposure, population, and outcome, but sample size is related to study design and not the formulation of the question itself.

Question 5

Rx means:

A. Refill
B. Diagnosis
C. Received
D. Take thou

Answer 5

D. Take thou

Rationale: “Rx” is an abbreviation of the Latin word “recipe,” meaning “take thou.” It is commonly used to indicate a prescription.

Question 6

Distribution of drugs to specific tissues:

A. Depends on the unbound drug concentration gradient between blood and tissue
B. Is dependent on blood flow to the organ
C. Has no effect on the half-life of the drug
D. Is increased for drugs that are strongly bound to plasma proteins
E. Is independent of the solubility of the drug in that tissue

Answer 6

A. Depends on the unbound drug concentration gradient between blood and tissue

Rationale: Drug distribution to tissues is largely influenced by the concentration gradient of the unbound (free) drug between the blood and the tissues. This gradient drives the passive diffusion of the drug into tissues.

Question 7

True regarding legislation of drugs:

A. Ensures therapeutic efficacy and safety of drug products
B. Regulates prescription of drugs
C. Facilitates production and/or acquisition of an adequate supply of drugs
D. All of the above

Answer 7

D. All of the above

Rationale: Legislation of drugs ensures therapeutic efficacy and safety of drug products, regulates prescription of drugs, and facilitates the production and/or acquisition of an adequate supply of drugs, encompassing all the listed points.

Question 8

Creatinine clearance is used as a measurement of:

A. Passive renal absorption
B. Active renal secretion
C. Renal excretion rate
D. Glomerular filtration rate (GFR)
E. Drug metabolism rate

Answer 8

D. Glomerular filtration rate (GFR)

Rationale: Creatinine clearance is commonly used to estimate the glomerular filtration rate (GFR), which reflects how well the kidneys are filtering blood.

Question 9

This is a drug marketed under the name of another drug for deception:

A. Fake medicine
B. Spurious drug
C. Generic mislabeling
D. Counterfeit drug

Answer 9

D. Counterfeit drug

Rationale: A counterfeit drug is a medication that is fraudulently produced or mislabeled with the intent to deceive and is marketed under the name of another drug.

Question 10

A drug is said to be potent when:

A. It produces maximal response
B. It produces minimal/no side effects
C. It has a rapid onset of action
D. The amount needed to produce a certain response is less

Answer 10

D. The amount needed to produce a certain response is less

Rationale: Potency refers to the amount of a drug required to produce a given effect. A potent drug produces the desired effect at a lower dose compared to less potent drugs.

Question 11

Clinical development represents the shift from _____ to ______:

A. Laboratory science to patented research technology
B. Lead compound to patented therapeutic research
C. Project management responsibilities needed to manage human trials
D. Laboratory science to project management responsibilities needed to manage human trials

Answer 11

D. Laboratory science to project management responsibilities needed to manage human trials

Rationale: Clinical development involves moving from the basic laboratory science stage to the management of human clinical trials, requiring project management skills to oversee these trials.

Question 12

This is the integration of the best available research evidence with clinical expertise and patient values:

A. Evidence-based Medicine
B. Evidence-based guidelines
C. Evidence-Based Decision-making
D. Evidence-Based Research

Answer 12

A. Evidence-based Medicine

Rationale: Evidence-based Medicine (EBM) involves integrating clinical expertise, patient values, and the best available research evidence in making decisions about patient care.

Question 13

The first step in producing a literature review:

A. Write the question
B. Manage your references
C. Write the review
D. Search the literature

Answer 13

A. Write the question

Rationale: The first step in producing a literature review is to define a clear and focused research question that will guide the literature search and review process.

Question 14

In PICO, C is compared to:

A. Placebo
B. Gold standard
C. Both Placebo and gold standard are acceptable
D. Option 4

Answer 14

C. Both Placebo and gold standard are acceptable

Rationale: In the PICO framework, C stands for Comparison, which can be either a placebo or the current gold standard treatment.

Question 15

A known standard of therapy that is used to fully evaluate the safety and efficacy of a new drug:

A. Negative control
B. Orphan drug
C. Positive control
D. Testing control

Answer 15

C. Positive control

Rationale: A positive control is a treatment that is known to be effective and is used in clinical trials to compare and evaluate the safety and efficacy of a new drug.

Question 16

Indicate the phase of clinical trial in the development of a new drug being described: Goal is to identify major side effects, metabolism, and routes of excretion:

A. Phase II
B. Phase IV
C. Phase III
D. Phase I
E. Pre-clinical

Answer 16

D. Phase I

Rationale: Phase I clinical trials are conducted to determine the safety, dosage range, and side effects of a new drug, as well as its metabolism and routes of excretion.

Question 17

Drug reactions caused by metabolites, which are non-active therapeutic ingredients, are not reportable.

A. True
B. False

Answer 17

B. False

Rationale: Drug reactions caused by metabolites, whether active or inactive, are reportable as they can contribute to adverse drug reactions.

Question 18

Which is the highest level of evidence?

A. Case control
B. Expert opinion
C. Cohort
D. RCT (Randomized Controlled Trial)

Answer 18

D. RCT (Randomized Controlled Trial)

Rationale: Randomized Controlled Trials (RCTs) are considered the highest level of evidence due to their ability to minimize bias and establish causality.

Question 19

This law aims to promote, require and ensure production and adequate supply, distribution, and acceptance of medications identified by their generic names:

A. EO 851
B. EO 94
C. RA 6675
D. RA 3720, 1963

Answer 19

C. RA 6675

Rationale: RA 6675, also known as the Generic Act of 1988, aims to promote the use of generic drug names for the purpose of ensuring the availability and affordability of essential medicines.

Question 20

The law/s that created and rectified the Food, Drug & Cosmetic Act:

A. RA 6675
B. BC 8 s. 2001
C. RA 3720; 1963 & EO 175; 1987
D. AO 67 s. 1989; BC 5 s. 1997

Answer 20

C. RA 3720; 1963 & EO 175; 1987

Rationale: RA 3720 established the Food, Drug, and Cosmetic Act in 1963, and EO 175 in 1987 rectified it.

Question 21

Monitoring plasma drug concentration is useful while using:

A. Levodopa
B. Antihypertensive drugs
C. Lithium carbonate
D. MAO inhibitors

Answer 21

C. Lithium carbonate

Rationale: Monitoring plasma drug concentration is especially important for drugs like lithium carbonate, which has a narrow therapeutic window and requires careful dosing to avoid toxicity.

Question 22

Which of the following must be present in a valid spontaneous individual case report? (Choose ALL CORRECT RESPONSES)

A. Suspect product
B. Identifiable reporter
C. Dosage
D. Excipient substances
E. Location of event
F. Patient
G. Event

Answer 22

A. Suspect product, B. Identifiable reporter, F. Patient, G. Event

Rationale: A valid spontaneous individual case report must include a suspect product, an identifiable reporter, a patient, and an event to ensure all necessary information is available for proper evaluation.

Question 23

27. A graph of the therapeutic index of warfarin is shown in the following figure. Which of the following statements is true?

A. Unwanted adverse events are unlikely with this agent
B. The therapeutic window is large
C. Unwanted adverse events are unlikely dose-related
D. There is a small window of desired effect of this medication

Answer 23

D. There is a small window of desired effect of this medication

Rationale: The graph shows a narrow therapeutic window for warfarin, indicating that the range between the effective dose and the dose that causes adverse effects is small. This means there is a small margin of safety, and careful monitoring of the drug levels is required to avoid toxicity while ensuring therapeutic efficacy.

Question 24

A serious adverse event (SAE) is which of the following? (Check ALL correct responses, all or nothing)

A. Congenital Anomaly
B. Results in temporary incapacity
C. Life-threatening
D. Requires hospitalization

Answer 24

A. Congenital Anomaly
C. Life-threatening
D. Requires hospitalization
Rationale: Serious adverse events (SAEs) include congenital anomalies, life-threatening conditions, and events requiring hospitalization. Temporary incapacity is not typically classified as an SAE unless it leads to significant disability or incapacity.

Question 25

High plasma protein binding:

A. Generally makes the drug long acting
B. Increases the volume of distribution of the drug
C. Minimizes drug interactions
D. Facilitates glomerular filtration of the drug

Answer 25

A. Generally makes the drug long acting

Rationale: High plasma protein binding typically results in a longer duration of action for the drug because the bound drug is not readily available for metabolism and excretion.

Question 26

For “as needed” medications, it is important to write down:

A. The common adverse reactions to the drug
B. The indication for use and when to take it
C. The brand name of the drug
D. The color of the tablet

Answer 26

B. The indication for use and when to take it

Rationale: For “as needed” medications, the indication for use and the specific circumstances or symptoms for when to take the medication should be clearly written to ensure proper usage and effectiveness.

Question 27

A novel medication designed to treat lymphoma can be administered via injection or orally. If the drug is given orally, an estimation of the area under the curve for this dose may be represented by which of the following letters in the following figure?

A. Letter B
B. Letter A
C. Letter C
D. Letter E
E. Letter D

Answer 27

A. Letter B

Rationale: The area under the curve (AUC) for a drug administered orally typically represents the bioavailability of the drug, which is usually less than that of an intravenous (IV) administration due to factors such as first-pass metabolism and incomplete absorption. In the figure, Letter B represents a smaller AUC compared to the IV administration (likely represented by Letter D), indicating a lower bioavailability, which is consistent with oral administration.

Question 28

What is the primary focus of Phase III clinical testing?

A. How to manage costs
B. Optimal range of effective dosage
C. Analysis of data results from subset target population
D. Collection and analysis of highly specific efficacy endpoint data

Answer 28

D. Collection and analysis of highly specific efficacy endpoint data

Rationale: Phase III clinical trials are primarily focused on gathering more detailed information on efficacy and safety by analyzing highly specific endpoints in a larger patient population.

Question 29

Pharmacodynamics include:

A. The biological effects produced by chemicals
B. The site/s and mechanism by which the biological effects are produced
C. All of the above
D. The factors that affect the safety and effectiveness of the agent

Answer 29

C. All of the above

Rationale: Pharmacodynamics encompasses the biological effects produced by chemicals, the sites and mechanisms of these effects, and factors affecting the safety and effectiveness of the agent.

Question 30

Which phase of the clinical drug trial is ongoing?

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

Answer 30

C. Phase IV

Rationale: Phase IV clinical trials are ongoing studies conducted after a drug has been approved for market, focusing on long-term safety, effectiveness, and other aspects of the drug in a larger population.

Question 31

The loading dose (DL) of a drug is usually based on the:

A. Area under the plasma drug concentration versus time curve (AUC)
B. Total body clearance (ClT) of the drug
C. Apparent volume of distribution (VD) and desired drug concentration in plasma
D. Percentage of drug bound to plasma proteins
E. Fraction of drug excreted unchanged in the urine

Answer 31

C. Apparent volume of distribution (VD) and desired drug concentration in plasma

Rationale: The loading dose is calculated to rapidly achieve the desired plasma concentration of the drug and is based on the volume of distribution (VD) and the target concentration.

Question 32

True of Special Prescription Form for Dangerous Drugs (SPFDD):

A. Used for over-the-counter medications
B. Filled in triplicate
C. Does not require an S2 license
D. Refillable

Answer 32

B. Filled in triplicate

Rationale: SPFDDs are filled in triplicate to ensure proper documentation and control of the prescription of dangerous drugs.

Question 33

A drug contains too much of an active ingredient. It is defined as a drug that is:

A. Overdosed
B. Underwritten
C. Over prescribed
D. Substandard

Answer 33

D. Substandard

Rationale: A substandard drug is one that does not meet quality specifications, including having too much or too little of an active ingredient.

Question 34

Indicate the phase of clinical trial in the development of a new drug being described: Typically involves 20-80 healthy volunteers (no women of childbearing potential):

A. Phase IV
B. Phase I
C. Pre-clinical
D. Phase III
E. Phase II

Answer 34

B. Phase I

Rationale: Phase I trials are the first stage of clinical testing in humans, typically involving 20-80 healthy volunteers to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug.

Question 35

The prescription is a medico-legal document:

A. False
B. True

Answer 35

B. True

Rationale: A prescription is indeed a medico-legal document that serves as an authoritative instruction from a healthcare provider to a pharmacist.

Question 36

Fixed dose drug combinations are outlawed by the FDA

A. True
B. False

Answer 36

B. False

Rationale: Fixed dose drug combinations are not outlawed by the FDA. They are regulated and must meet certain criteria for approval, but they are not prohibited.

Question 37

On what does Phase III trial test?

A. Healthy human volunteers
B. Large scale tests in people with the target disease
C. Widespread differentiated population
D. People with target disease

Answer 37

B. Large scale tests in people with the target disease

Rationale: Phase III trials involve large-scale testing in people with the target disease to confirm the drug’s effectiveness, monitor side effects, and collect data to ensure the drug can be used safely.

Question 38

The meat of the Rx includes all of the following, EXCEPT:

A. Registration number
B. Amount
C. Dose frequency
D. Route

Answer 38

A. Registration number

Rationale: The main components of a prescription (the “meat” of the Rx) include the drug name, amount, dose frequency, and route of administration. The registration number is not part of this section.

Question 39

Irrational use of drugs may lead to:

A. Decrease cost of treatment
B. Exacerbation of illness
C. Discovery of new drug
D. Effective and safe treatment

Answer 39

B. Exacerbation of illness

Rationale: Irrational use of drugs can lead to worsening of the illness, as well as other negative outcomes like resistance, increased side effects, and ineffective treatment.

Question 40

Berlin, a medical student, is doing a summer research project studying five antibiotics to determine potency using the EC50. Antibiotics are placed in plated culture wells with 100,000 CFU of Escherichia coli. The EC50 results for the five antibiotics are shown in the following choices. Based on the results, the most potent antibiotic is:

A. Antibiotic C EC50 = 80
B. Antibiotic A EC50 = 100
C. Antibiotic B EC50 = 2
D. Antibiotic D EC50 = 20
E. Antibiotic E EC50 = 50

Answer 40

C. Antibiotic B EC50 = 2

Rationale: The EC50 (effective concentration for 50% of the population) is a measure of drug potency. The lower the EC50, the more potent the drug. Antibiotic B with an EC50 of 2 is the most potent.

Question 41

What source is used in pre-clinical testing?

A. Plants
B. Various lab specimens
C. Humans
D. Animals

Answer 41

D. Animals

Rationale: Pre-clinical testing involves studies in animals to gather preliminary efficacy, toxicity, and pharmacokinetic information before human trials.

Question 42

Which phase of the clinical drug trial is considered as pharmacovigilance?

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

Answer 42

B. Phase IV

Rationale: Phase IV trials, also known as post-marketing surveillance, involve pharmacovigilance to monitor the long-term safety and effectiveness of a drug after it has been approved for market use.

Question 43

Bioavailability of a drug is:

A. The dose of a drug by which 50% animals show signs of toxicity
B. The percentage of drug released from a formulation that becomes available for biological effect
C. The net amount of actual therapeutic agent present in the formulation
D. The percentage of drug that is ionized from a formulation

Answer 43

B. The percentage of drug released from a formulation that becomes available for biological effect

Rationale: Bioavailability refers to the proportion of the administered drug that reaches the systemic circulation and is available to have an active effect.

Question 44

If a drug is eliminated by first-order kinetics:

A. Its elimination half-life will increase with dose
B. A constant amount of the drug will be eliminated per unit time
C. Its clearance value will remain constant
D. It will be completely eliminated from the body in 2 x half-life period

Answer 44

C. Its clearance value will remain constant

Rationale: In first-order kinetics, the rate of drug elimination is proportional to the drug concentration, and the clearance rate remains constant regardless of the dose.

Question 45

A drug that binds to a receptor and produces a biological response that mimics the response to the endogenous ligand is known as:

A. Partial antagonist
B. Agonist
C. Functional antagonist
D. Antagonist
E. Partial agonist

Answer 45

B. Agonist

Rationale: An agonist is a substance that binds to a receptor and activates it, mimicking the action of an endogenous ligand.

Question 46

If the plasma concentration of a drug declines with “first-order kinetics”, this means that:

A. The drug is not distributed outside the vascular system
B. The half-life is the same regardless of the plasma concentration
C. The rate of elimination is proportionate to the rate of administration at all times
D. The drug is largely metabolized in the liver after oral administration and has low bioavailability
E. There is only one metabolic path for drug disposition

Answer 46

B. The half-life is the same regardless of the plasma concentration

Rationale: In first-order kinetics, the rate of drug elimination is proportional to the drug concentration, and the half-life remains constant regardless of the plasma concentration.

Question 47

Identify the correct EBM sequence:

A. Ask Assess Apply Appraise Acquire
B. Apply Assess Assimilate Appraise Ask
C. Acquire Appraise Apply Assess Ask
D. Assess Appraise Ask Acquire Apply
E. Ask Acquire Apply Appraise Assess
F. Ask Acquire Appraise Apply Assess
G. Ask Appraise Assess Apply Assimilate
H. Acquire Ask Appraise Apply Assess
I. Analyze Ask Acquire Assess Apply

Answer 47

F. Ask Acquire Appraise Apply Assess

Rationale: The correct sequence in Evidence-Based Medicine (EBM) is to first formulate a question (Ask), then gather information (Acquire), critically evaluate the evidence (Appraise), apply the findings to clinical practice (Apply), and finally assess the outcomes (Assess).

Question 48

Two drugs are shown in the following figure. Both are antibiotics used to treat bacterial pneumonia. Which of the following statements is correct about the figure shown next?

A. Drug B has a lower EC50
B. Drug B should be given intramuscularly
C. Drug A is less potent than Drug B
D. Drug A has a lower EC50
E. Drug A should be given intravenously

Answer 48

D. Drug A has a lower EC50

Rationale: The figure shows dose-response curves for two drugs. The EC50 is the concentration of the drug that produces 50% of its maximal effect. Drug A reaches 50% of its maximal effect at a lower concentration than Drug B, indicating that Drug A has a lower EC50 and is therefore more potent.

Question 49

Disadvantage of Fixed dose combination:

A. Increased pill burden
B. Option 5
C. Limited availability
D. Impractical
E. Decreased patient adherence

Answer 49

D. Impractical

Rationale: Fixed-dose combinations can be impractical if doses need to be adjusted individually for the drugs involved, as it can limit flexibility in dosing.

Question 50

An adverse event requires the establishment of a causal relationship with the suspect drug.

A. True
B. False

Answer 50

B. False

Rationale: An adverse event does not necessarily require a proven causal relationship with the suspect drug; it simply refers to any undesirable experience associated with the use of a medical product.

Question 51

This is a mislabeled drug made to appear as a true medication for therapy:

A. Generic mislabeling
B. Bioequivalent medicine
C. Brand imitation
D. Fake medicine

Answer 51

D. Fake medicine

Rationale: A fake medicine is a mislabeled drug intended to deceive and appear as a legitimate medication, often lacking the proper active ingredients or containing incorrect ingredients.

Question 52

The first description of therapeutic drug monitoring that we have on record using bromides and establishing of therapeutic concentrations of bromide as a sedative was conducted in 1927 by:

A. Dr. Harry Gold
B. Dr. Paul Martini
C. Dr. McKeen Cattell
D. Dr. O Wuth

Answer 52

B. Dr. Paul Martini

Rationale: Dr. Paul Martini is credited with the first recorded use of therapeutic drug monitoring with bromides in 1927.

Question 53

The burden of reporting a serious adverse reaction is a responsibility of the patient because without patient consent, the report is invalid.

A. True
B. False

Answer 53

B. False

Rationale: The responsibility of reporting a serious adverse reaction typically falls on healthcare providers, not the patient. Consent is not a requirement for reporting adverse reactions to regulatory authorities.

Question 54

The quantity of the drug to be taken is written in the:

A. Description
B. Inscription
C. Subscription
D. Superscription

Answer 54

C. Subscription

Rationale: The subscription section of a prescription includes instructions to the pharmacist on the quantity of the drug to be dispensed.

Question 55

This requires animal data:

A. New Drug Application
B. Orphan Drug
C. Treatment IND
D. IND

Answer 55

D. IND (Investigational New Drug)

Rationale: An Investigational New Drug (IND) application requires animal data to support the initial testing of a new drug in humans.

Question 56

A drug which does not produce any action by itself but decreases the slope of the log dose-response curve and suppresses the maximal response to another drug is a:

A. Noncompetitive antagonist
B. Competitive antagonist
C. Physiological antagonist
D. Partial agonist

Answer 56

A. Noncompetitive antagonist

Rationale: A noncompetitive antagonist binds to a different site than the agonist and decreases the maximal response of the agonist without competing for the same binding site.

Question 57

Which of the following is not a primary/fundamental, but a derived pharmacokinetic parameter?

A. Clearance
B. Plasma half-life
C. Bioavailability
D. Volume of distribution

Answer 57

B. Plasma half-life

Rationale: Plasma half-life is a derived pharmacokinetic parameter, dependent on primary parameters like clearance and volume of distribution.

Question 58

Involves drug metabolism and safety assessment:

A. Phase I, II, and III
B. Phase I and II
C. Phase II and III
D. Phase IV

Answer 58

B. Phase I and II

Rationale: Phase I and II trials involve drug metabolism and safety assessment, with Phase I focusing on safety and pharmacokinetics, and Phase II focusing on efficacy and side effects.

Question 59

Indicate the phase of clinical trial in the development of a new drug being described: Clinical studies on limited scale:

A. Phase II
B. Phase I
C. Phase III
D. Phase IV
E. Pre-clinical

Answer 59

A. Phase II

Rationale: Phase II clinical trials are conducted on a limited scale to assess the efficacy and side effects of a drug in a small group of patients.

Question 60

Which is a known side effect of atropine?

A. Dry mouth
B. Diuresis
C. Sedation
D. Diarrhea

Answer 60

A. Dry mouth

Rationale: Atropine is known to cause dry mouth as a side effect due to its anticholinergic properties.

Question 61

True regarding treatment IND except:

A. Under investigation in clinical trial (usually Phase II)
B. Intended to treat serious life-threatening conditions
C. No comparable satisfactory alternative treatment
D. Sponsor actively pursuing marketing approval

Answer 61

A. Under investigation in clinical trial (usually Phase II)

Rationale: Treatment INDs are for patients with serious or life-threatening conditions who cannot participate in ongoing clinical trials, and the drug is typically in Phase III or beyond, not usually Phase II.

Question 62

The following statements are true regarding Phase II of clinical trial EXCEPT:

A. The effects are compared with similar patients receiving different treatment
B. None of the above
C. Emphasis is on efficacy
D. Usually involves 100-300 volunteers

Answer 62

A. The effects are compared with similar patients receiving different treatment

Rationale: Phase II trials focus on the efficacy of the drug and involve 100-300 patients, but the effects are typically compared with a placebo or standard treatment in Phase III trials.

Question 63

Which of the following is not mandatorily seen in a prescription?

A. Doctor’s Address
B. Doctor’s Professional Tax Receipt Number for private practitioners
C. Doctor’s organizational affiliations
D. Doctor’s License number

Answer 63

C. Doctor’s organizational affiliations

Rationale: A doctor’s organizational affiliations are not typically required on a prescription, whereas the address, professional tax receipt number (for private practitioners), and license number are mandatory.

Question 64

Indicate the phase of clinical trial in the development of a new drug being described: Lasts about 3 years, approximately 25-30% will pass this phase:

A. Phase I
B. Phase IV
C. Pre-clinical
D. Phase III
E. Phase II

Answer 64

E. Phase II

Rationale: Phase II clinical trials generally last about 3 years, and approximately 25-30% of drugs pass this phase to proceed to Phase III trials.

Question 65

A pharmacist with a known address reports a case of a 56-year-old female who took Pregabalin and was hospitalized due to hypertension.

A. Invalid and non-serious
B. Valid and non-serious
C. Invalid and serious
D. Valid and serious

Answer 65

D. Valid and serious

Rationale: This report is valid because it includes a known reporter, a patient, and a serious adverse event (hospitalization due to hypertension).

Question 66

Which of the following is true of placebos?

A. Placebo is the inert material added to the drug for making tablets
B. All patients respond to placebos
C. Placebos do not produce any effect
D. Placebo is a dummy medication

Answer 66

D. Placebo is a dummy medication

Rationale: A placebo is an inert or dummy medication given to some participants in clinical trials to compare the effects of the actual drug.

Question 67

In target concentration strategy determining the maintenance dose, the concept/s being applied is/are:

A. Elimination half-life and clearance
B. Volume of distribution
C. All of the above
D. First-order kinetics

Answer 67

C. All of the above

Rationale: Determining the maintenance dose involves considering the elimination half-life, clearance, volume of distribution, and the principles of first-order kinetics.

Question 68

Bio-transformation of the drugs is to render them:

A. Less protein-bound
B. Less lipid soluble
C. More protein-bound
D. Less ionized

Answer 68

B. Less lipid soluble

Rationale: The primary goal of biotransformation is to make drugs less lipid-soluble (more water-soluble) to facilitate their excretion from the body.

Question 69

Which of the following is included in a yellow prescription which is not needed in an ordinary prescription?

A. S2 license
B. Diagnosis
C. Number of tablets written in word form
D. All of the above

Answer 69

D. All of the above

Rationale: A yellow prescription for dangerous drugs includes the S2 license number, diagnosis, and the number of tablets written in word form, unlike an ordinary prescription.

Question 70

This drug enables patients not qualified for participation in ongoing studies to be treated:

A. Orphan Drug
B. New Drug Application
C. Treatment IND
D. IND

Answer 70

C. Treatment IND

Rationale: A Treatment IND allows patients who do not qualify for ongoing clinical trials to receive investigational drugs for serious or life-threatening conditions.

Question 71

An allergic reaction occurs after an antibiotic treatment has been stopped. What type of reaction is this?

A. Immediate hypersensitivity reaction
B. Delayed hypersensitivity reaction
C. Idiosyncratic reaction
D. Dose-dependent reaction

Answer 71

B. Delayed hypersensitivity reaction

Rationale: A delayed hypersensitivity reaction occurs some time after the initial exposure to the allergen, often after the treatment has been stopped.

Question 72

What is the synonym/description for the Phase 4 trials?

A. Post Marketing Surveillance
B. Pre FDA Approval
C. Post FDA Approval
D. Pre Marketing Surveillance

Answer 72

A. Post Marketing Surveillance

Rationale: Phase 4 trials, also known as post-marketing surveillance, involve monitoring the drug’s safety and efficacy after it has been approved for marketing.

Question 73

Which of the following drug equations exemplifies the concepts of potentiation?

A. Drug AB < Drug A < Drug B
B. Drug AB = Drug B > Drug A
C. Drug AB > Drug A + Drug B
D. Drug AB = Drug A = Drug B

Answer 73

C. Drug AB > Drug A + Drug B

Rationale: Potentiation occurs when the combined effect of two drugs is greater than the sum of their individual effects, as exemplified by Drug AB > Drug A + Drug B.

Question 74

FDA approval to market a new drug for clinical use:

A. IND
B. Treatment IND
C. New Drug Application
D. Orphan Drug

Answer 74

C. New Drug Application

Rationale: A New Drug Application (NDA) is submitted to the FDA to obtain approval to market a new drug for clinical use.

Question 75

SPFDD allows drug refills:

A. False
B. True

Answer 75

A. False

Rationale: Special Prescription Forms for Dangerous Drugs (SPFDD) do not allow for drug refills to ensure controlled dispensing.

Question 76

Reportable drug reactions can have either negative or positive effects.

A. True
B. False

Answer 76

A. True

Rationale: Reportable drug reactions can include both adverse (negative) and unexpected beneficial (positive) effects.

Question 77

Control of biases refers to all of the following, EXCEPT:

A. Ethics
B. Internal Validity
C. Sampling methods
D. Sample

Answer 77

A. Ethics

Rationale: Controlling biases in research primarily involves internal validity, sampling methods, and sample, while ethics is a broader concept related to the conduct of research.

Question 78

Published literature reports are not reported to authorities in Pharmacovigilance because they are already documented.

A. True
B. False

Answer 78

B. False

Rationale: Published literature reports are still reported to pharmacovigilance authorities to ensure all data is monitored and assessed for drug safety.

Question 79

This defines the way drugs must be prescribed in the Philippines:

A. Philippine Pharmaceutical Directory
B. RA 9165
C. Generics Act of 1988
D. Philippine National Drug Formulary

Answer 79

C. Generics Act of 1988

Rationale: The Generics Act of 1988 defines how drugs must be prescribed in the Philippines, promoting the use of generic names.

Question 80

Bestow certain advantages on companies that develop drugs for unusual diseases:

A. New Drug Application
B. IND
C. Treatment IND
D. Orphan Drug

Answer 80

D. Orphan Drug

Rationale: The Orphan Drug designation provides incentives to companies that develop drugs for rare or unusual diseases.

Question 81

Which phase of testing is followed by presenting to the FDA for approval?

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

Answer 81

C. Phase III

Rationale: After successful completion of Phase III trials, the data is presented to the FDA for approval to market the drug.

Question 82

Pharmacokinetics is:

A. The study of absorption, distribution, metabolism, and excretion of drugs
B. The study of biological and therapeutic effects of the drugs
C. The method of development of new pharmacological agents
D. The study of carcinogenic activity of a new drug

Answer 82

A. The study of absorption, distribution, metabolism, and excretion of drugs

Rationale: Pharmacokinetics involves studying how the body absorbs, distributes, metabolizes, and excretes drugs.

Question 83

Indicate the phase of clinical trial in the development of a new drug being described: Investigate through well-controlled studies with different populations and different dosages:

A. Phase IV
B. Phase I
C. Pre-clinical
D. Phase III
E. Phase II

Answer 83

D. Phase III

Rationale: Phase III trials are large-scale studies that investigate the drug’s efficacy and safety in different populations and dosages through well-controlled studies.