Samplex 2017 Flashcards
Based on 1966 WHO definition of a drug, which is not a drug?
A. BCG vaccination given to prevent TB B. Penicillin given to eradicate streptococcal infection in a patient with rheumatic fever C. Synthetic adrenocorticotropic hormones given to detect the presence of Addison’s disease D. Methamphetamine inhalation to achieve euphoria but frequently leads to something, heart disease, psychosis
D
Apothecaries in the history of pharmacology refers to:
A. Collection of folkloric tales about herbal remedies B. Pharmacies or drugstores where medicines are sold C. Laboratories where natural products are purified and active drugs are isolated D. Clinics where doctors prescribe herbal medicine
B
Patient with asthma presents with bronchoconstriction. Which drug casues delayed but prolonged bronchodilation?
A. Glucocorticoid through GCPR B. b-adrenergic through GCPR C. Glucocorticoid through enzyme-linked receptor D. Glucocorticoid inside cytoplasmic/nuclear receptor
D
The action of mannitol of decreasing intracranial pressure is mediated by this type of receptor:
A. Ionotropic B. Metabotropic C. GPCK D. NOTA
D
Use of an allosteric activatior with another drug will result in:
A. Decreased efficacy of drug B. Increased efficacy of drug C. Decreased potency of drug D. Increased potency of drug
NA
When acetylcholine binds to nicotine receptors:
A. Open Na+ channels B. Generate CAMP C. Gene expression D. Activate tyrosine kinase
NA
Allosteric activator cause effects:
A. Greater than agonist alone B. Less than agonist alone C. Equal to agonist alone D. Opposite the action of agonist
A
Glucocorticoid hydrocotisone binds to the following receptor:
A. Ionotropic B. GPCR C. Tyrosine kinase D. Cytoplasmic/nuclear receptor
D
Benzodiazepine, after binding to its target receptor, causes what changes?
A. Separation of the Gsa subunit from Gb and Gγ protein subunits B. Autophosphorylation of the beta subunit of the receptor C. Direct opening of ionophore channel causing exit of sodium D. Conformational change of GABA receptor causing improved GABA binding
D
The ff. contribute to the development of desensitization/tachyphylaxis:
A. Endocytosis of receptors B. Phosphorylation C. Compensation D. Exocytosis of receptors
D
Tamoxifen is said to be a partial agonist. It would have the ff. properties:
A. It would be antagonistic at very high dose. B. It functions as an antagonist in breast tissue but is agonistic in bone. C. Change the configuration of estrogen receptor which causes it to fail.
B
Bevacuzimab (Avastin) is a newly discovered chemotherapeutic drug released and marketed since
2011. Dr. Bernardo wanted to determine the effects of the drug to his ovarian cancer patients. Roche, a pharmaceutical company, gave him a grant to determine the adverse effects of the drug.
A. Phase I B. Phase II C. Phase III D. Phase IV
D
A group of scientists want to discover the effects of the makahiya plant on insulin resistance. A clinical trial was conducted using rat models, and monitored the concentration of the plant in the kidneys using western blot analysis. Also measured blood sugar, serum insulin, and HBA1C levels
A. Phase I B. Phase II C. Pre-clinical D. Phase IV
D
RCT, open-labelled, humans, 600+ DM Type 2, 69 worldwide sites
A. Phase I B. Phase II C. Phase III D. Phase IV
C
Efficacy of drug with Dry Eye Syndrome. Trial involving 200 patients
A. Phase I B. Phase II C. Phase III D. Phase IV
B
While receptors regulate biochemical and physiological activity, they are also subject to regulatory mechanisms, such as:
A. Upregulation due to synthesis of new receptors B. Upregulation due to continued stimulation C. Downregulation due to covalent bonding and destruction of receptors. D. A & C E. AOTA
NA
Dose-response curve:
A. Hyperbola B. Sigmoid C. 4 parameters: efficacy, potency, slope, variability D. AOTA E. B & C only
E
A quantal-dose response:
A. Defined as the population frequency in response to varying doses B. All or none C. Gaussian D. A & C E. AOTA
NA
Potency is:
A. Effectiveness of drug relative to dose B. Importance is considered where ease of administration ends C. Sigmoid on the horizontal axis D. B & C E. All of the above
NA
Pharmacokinetics:
A. Deals with what body does to the drug B. Consists of disposition and elimination C. Consists of absorption, distribution, metabolism and excretion D. A & C E. AOTA
E
Proactive drugs are used for the ff.:
A. For easier oral absorption B. Improve safety C. To test the liver D. A & B E. AOTA
D
The Cyp450 microsomal enzyme that is responsible for most (greater part of) metabolism of drugs:
A. Cyp1A (Another one said Cyp2A1) B. Cyp3A4 C. Cyp2C1 D. Cyp2D1 E. Cyp2E1
B
For 99% of the drug to be eliminated from the body, the minimum number of half-lives that should have been completed is:
A. 3 B. 4 C. 5 D. 6 E. 7
E
RA 9711 of FDA of 2009 defined drugs as:
A. Articles that cure, mitigate, prevent, treat, and diagnose disease states in humans and animals B. Processed food that alter physiological states of humans and animals C. Processed herbal products D. AOTA
A
In AO 172 S2004, Herbal Medicine is defined as:
A. Finished labeled products B. Containing active ingredients whether in crude state or as plant preparation C. Contain plant material including juices, gums, fatty oils D. AOTA
D
Requirement of Philippine FDA for herbal medicines except:
A. Standard limits (e.g. Aflatoxin limits, microbial limits) B. Organoleptic characterictics and macroscopic appearance C. Mutagenicity and toxicity studies
C
The International Committee on Harmonization (ICH) Tripartite Guidelines on Non-clinical Safety Studies for the Conduct of Human clinical Trials state the ff. except:
A. Any substance or combination of substances which has a therapeutic, prophylactic, or diagnostic purpose, or is intended to modify physiological functions and presented in a dosage form suitable for administration in humans. B. To promote safe, ethical development and availability of new pharmaceuticals C. For situations encountered during the conventional development of pharmaceuticals D. For biotechnology-derived products pharmaceuticals for life-threatening or serious diseases without effective current therapy.
D
True of Acute Toxicity Non-clinical Studies:
A. 2 mammalian species using both clinical and parenteral routes; 1 dose; observed for 14 days B. Lethality is intended end point. C. Cannot be obtained from dose-escalation studies D. Cannot be used to predict consequences of human overdose
A
The ff. duration of Repeated Dose Toxicity studies are required of Pediatric population clinical trials:
A. Repeated dose-toxicity studies in animals B. All reproduction toxicity studies in animals C. Adult human safety data D. AOTA
NA
[T/F] Absorption of IV is 100%.
T
[T/F] Among the CYP450 enzymes, CYP3A4 is the most important because it metabolizes 33% of all drugs.
T
[T/F] Agonist binding has both efficacy and affinity.
T
[T/F] For a drug that behaves in a linear fashion, doubling the dose would mean doubling the Cmax but not AUC.
F
[T/F] For a drug that behaves in a linear fashion, doubling the dose would mean doubling the Cmax but not AUC.
An increase in Ki would mean an increase CL (faster) therefore Cmax is reached earlier.
T
Clearance of a drug is:
A. Volume of the drug cleared per unit of time B. Dependent on the blood flow to the clearing organ C. Equal to the elimination constant D. AOTA E. A & B only
NA
Given a drug in the body with initial concentration of 100 mg/L and half-life of 12 hours, what is the
concentration of the drug 24 hours later?
A. 50 mg/L B. 25 mg/L C. 15 mg/L D. 5 mg/L
B
What happens to the half-life of a drug if clearance is decreased by 75%?
A. T1/2 will be 4x as long B. T1/2 will be 32X as long C. T1/2 will be decreased by 75% D. There will be no effect.
NA
What is the best parameter in assessment of bioavailability in a particular route?
A. Half-life B. Cmax C. Tmax D. AUC E. Clearance rate
NA
Which of the ff. is incorrect?
A. Relative bioavailability is measured by obtaining the AUC of a drug’s IV form and extravascular form B. An orally administered drug, such as Propanolol, with an extensive 1st pass effect in the liver is absorbed less that its IV form C. The absorption of a drug starts in the stomach and small intestine and is dependent on dosage form and drug’s physicochemical properties D. An excessively hydrophobic drug such as Acyclovir is poorly absorbed
A
FDA bioavailability in vivo except:
A. Parenteral B. Capsules and tablets C. Oral solution D. Powder
B
Tablet 100 ng 95.6
Solution 100 ng 93.3
IV 50 ng 38.2
Which of the following is true?
A. Absorbed in IV bolus if 50 ng B. Absolute bioavailability of oral tablet is 0.73. C. Relative bioavailability of oral tablet is 1.02. D. There is no need to conduct bioequivalence study for oral tablet to establish bioequivalence. E. AOTA
NA
Clinical pharmacokinetic testing is done to:
A. Determine Drug response to the body B. Establish dosing regiment C. Determine if drug regimen is appropriate to patients. D. AOTA E. B & C
E
With continued infusion, steady state is achieved:
A. Dosing rate = rate of elimination B. Length of dosing is twice the biological half-life C. Total amount = required loading dose D. AOTA e. A & C only
A
Analysis of compartment models
A. Applicable to extravascular routes B. Direct relationship between concentration and effect C. Used with drugs with narrow therapeutic window D. AOTA
D
Biologic half-life of theophylline in this patient is?
A. 2 hours B. 3 hours C. 4 hours D. 5 hours
NA
Parenchymal liver disease affects what most?
A. Absorption B. Distribution C. Excretion D. Metabolism
D
The extent to which a drug is cleared in a single pass through the liver is:
A. Extraction ratio B. pKa C. Liberation D. NOTA
A
Which drug will have a prolonged half-life in parenchymal liver disease?
A. Ampicillin B. Phenytoin C. Acetaminophen D. Tolbutamide
C
Antibiotic that induces its own metabolism:
A. PAS B. INH C. Rifampicin D. Tolbutamide
NA
An anti-infective drug excreted 75% or unchanged in the kidney:
A. Methotrexate B. Atenolol C. Imipanem D. Methicillin
D
Methotrexate and Atenolol excrete 75% or more but are classified as “Others”. Methicillin is classified under beta-lactam antibiotics. Not sure about Imipanem.
Therapeutically equivalent drugs should have the ff. characteristics except:
A. Safe and effective B. Pharmaceutically equivalent and bioequivalent C. Same configuration, packaging, preservatives and expiration date D. Adequately labeled and manufactured in compliance with current GMP E. NOTA
NA
Cmax 88.7 98.7
AUC 0 - t 89.1 95.1
AUCt-∞ 98.1 121.1
Which of the following is true?
A. Pharmaceutical equivalent, bioequivalent B. Pharmaceutical equivalent, not bioequivalent C. Pharmaceutical alternative, bioequivalent D. Pharmaceutical alternative, not bioequivalent E. Pharmaceutical equivalent, therapeutic equivalent
NA
Cmax 88.7 98.7
AUC 0 - t 89.1 95.1
AUCt-∞ 98.1 121.1
Which of the following is true?
A. Pharmaceutical equivalent, bioequivalent B. Pharmaceutical equivalent, not bioequivalent C. Pharmaceutical alternative, bioequivalent D. Pharmaceutical alternative, not bioequivalent E. Pharmaceutical equivalent, therapeutic equivalent
NA
Adverse drug effects
A. ADR are unexpected and full reaction to drug at any dose
B. ADR are usually immunologic-related
C. ADR are unexpected and noxious at recommended dose
D. ADE are unexpected and noxious response with known causality
C
Adverse Drug Reaction (ADR) - is a response to a drug that is noxious and unintended in doses normally used in acceptable medical practice
The most common cause from ADR’s in the last decade is due to:
A. Drug-drug interaction
B. Anaphylaxis
C. Pharmacokinetic variation
A
Teratogenic effects are observed should women get pregnant within 2 years of taking this drug for acne A. Acetazolamide B. Azithromycin C. Thalidomide D. Accutane
D
Accutane is a brand name of Isotretinoin. Isotretinoin’s best-known and most dangerous side effect is birth defects. This is because of the molecule’s close resemblance to retinoic acid, a natural vitamin A derivative which controls normal embryonic development. Because of this, it is one of the most difficult pharmaceuticals to obtain in the United States
An example of side effect:
A. Anti-thrombotic caused by aspirin
B. GI bleeding caused by aspirin
B
Drug that should be avoided by patients with Brugada syndrome
A. Azithromycin
B. Amiodarone
C. Terfenadine
D. AOTA
D
Drug interactions with the antihistamines astemizole (recalled from US market) and terfenadine (recalled from US market) can precipitate torsade; these drugs should never be used with class IA, IC, or III agents. Astemizole and terfenadine, in high dosages or when used in combination with the azole antifungal drugs or the macrolide antibiotics, have been reported to precipitate torsade and sudden death.
Drugs that cause vasculitis or drug fever
a) Vitamins
b) allopurinol
c) carbamezepine
d) All of the above
D
Drugs that can cause vasculitis: Allopurinol, Carbamazepine, Cephalosporins, Ciprofloxacin, Clarithromycin, Hydralazine, Naproxen, Propylthiouracil, Terbutaline, Vitamins, Warfarin
Most common dermatologic manifestation of drug allergy.
A. Urticaria
B. Angioedema
C. Pemphigus
D. Morbilliform rash
D
Morbilliform rash – most common dermatologic manifestation of drug allergy