PHRM 828 Exams 1-3

The NECC disaster did not involve: a. Contaminated injections b. Low quality facilities c. Computer failures d. A, b, c

c. Computer failures

Which is not true about first in human studies (Phase I) a. An exploratory/learning phase of clinical program b. Establish safety and tolerability c. Establish doses for subsequent clinical trials d. Develop early indication of efficacy using biomarkers

c. Establish doses for subsequent clinical trials

The FDA inspection of KV found problems with: a. Labeling b. Packaging c. Management oversight d. Materials handling

c. Management oversight

True (A) or False (B): Cholesterol only has a harmful effect on biological membranes, playing a significant role in muscle pain and atherosclerosis.

False

True (a) or False (b): Bioavailability is the fraction of an administered dose that reaches the systemic circulation and the lymphatic flow intact.

False

True (A) or False (B): When blinding clinical trials, it is often important to mask the organoleptic properties of the comparator and the drug being tested. These senses include sight, smell, taste, touch, and sound.

True

True (a) or False (b): Absorption rate (kabs) is defined by the drug properties, the excipient/drug composition of the formulation, and the physiological barriers between the GI tract and systemic circulation. Ideally, formulators design the oral dosage forms to control kabs to balance disposition.

True

True (a) or False (b): Coatings can be applied to dosage forms for a number of purposes including protecting patients from the drug's potentially harmful effects, controlling the release of the drug to maintain the concentrations in the therapeutic window, and to even change appearance to provide an aesthetic appeal.

True

True (a) or False (b): Dosage forms have many functions that are conveyed through the interactions of the excipients, the drug's physicochemical properties and the physiological barriers that are designed to balance the disposition in the body

True

True (a) or False (b): Drug levels observed in the therapeutic window can be governed in part by transporters and metabolism, based on the compound being studied. Therefore, transporters and enzymes can play an important role in drug product performance.

True

True (a) or False (b): Paracelsian theory states that a chemical might have no effect on an organism, a beneficial effect, or a toxic effect. In fact, the dose dictates whether or not a chemical is a poison or a remedy.

True

True (a) or False (b): The microenvironmental pH at the surface of a cell membrane is different than that of the bulk fluid in the GI tract. This is one of several reasons why we cannot rely on the use the pH partition hypothesis for estimating absorption of ionized drugs

True

The salt solubility of the compound in the above plot is: a. 10 mg/mL b. 0.001mg/mL c. 1 mg/mL d. 100 mg/mL

a. 10 mg/mL

Binders are a. Adhesive materials used to hold powders together b. Improve powder flow properties c. Decrease adhesion to punch/die d. Aid in breaking up the tablet

a. Adhesive materials used to hold powders together

Production and process control includes a. All product ingredients b. Structure, space, design, and placement of equipment c. HVAC d. Document control

a. All product ingredients

Micromeretic properties (small particle properties) include a. Angle of repose b. Deliquescence c. X-ray diffraction pattern d. All of the above are micromeretic properties

a. Angle of repose

Which is not true about communition a. Can be done in a granulator b. Can be done in a mortar and pestle c. Can be done by a ball mill d. Can be done by a hammer mill

a. Can be done in a granulator

Drug standards are not set by a. Good housekeeping b. The United States Pharmacopeia and the National Formulary c. Other pharmacopeias d. FDA

a. Good housekeeping

Which of the following functional groups are basic? a. Amides b. Amines c. Aldehydes d. Alcohols

b. Amines

The quality wheel emphasizes the following activity after the product is on the market a. Product quality attributes b. Continuous improvement c. Process performance d. Process design

b. Continuous improvement

Capsules are not tested for a. Dissolution b. Friability c. Weight variation d. disintegration

b. Friability

Biologic Characterization does not include a. Pharmacology b. Impurity profile c. Drug metabolism d. Toxicology

b. Impurity profile

Which is not a universal test for a new drug substance a. Identification - IR, or combination of chromatography HPLC-MS. b. Polymorphic form c. Assay d. Impurities

b. Polymorphic form

Clinical trial designs include a. Leave one out b. Single crossover c. Partition coefficient d. Hydrolysis

b. Single crossover

The above plot shows a pH solubility profile for: a. A weak acid with a unionized form solubility of 0.001mg/mL b. A weak acid with an unionized form solubility of 10mg/ml c. A weak base with an unionized form solubility of 0.001 mg/mL d. A weak base with an unionized form solubility of 10mg/ml

c. A weak base with an unionized form solubility of 0.001 mg/mL

For an Abbreviated new drug application a. Phase 4 studies are required b. Nonclinical laboratory studies can be omitted c. Carcinogenicity studies are required d. A, and b

d. A, and b

Quality issues extend to: a. APIs b. Drug products c. Compounding Pharmacies d. A, b, and c

d. A, b, and c

Which is not a quality of a good tablet a. Accurate and uniform weight b. Stability and hardness c. Ease of disintegration d. All are qualities of a good tablet

d. All are qualities of a good tablet

Steps in a wet granulation process involve: a. Preparing the damp mass b. Screening the damp mass into pellets or granules c. Drying the granulation d. All are steps in wet granulation

d. All are steps in wet granulation

Capsule filling is done using a. Auger fill b. Vibratory fill c. Piston tamp d. All of the above

d. All of the above

Soft gelatin capsules can contain a. Single liquid b. Combination of liquids c. Suspension d. All of the above

d. All of the above

Tablets deterioriate by a. Loss of volatile constituents b. Oxidative deterioration c. Cementation d. All of the above

d. All of the above

Solids that take up water can be termed a. Hygroscopuc b. Deliquescent c. Polymorphic d. Both a and b

d. Both a and b

There are several different types of epithelia. From the list below, please select the one type that is NOT an epithelial cell type: A) Circumventricular columnar B) Simple squamous C) Simple columnar D) Translational E) Stratified squamous

A) Circumventricular columnar

Please select the following statement that is TRUE? A) All excipients are inert. B) A generic product judged therapeutically equivalent to the reference listed drug will have the same identity, strength, quality, safety, and efficacy C) Pharmaceutical equivalence is not part of the generic drug requirements D) Bioequivalence is a way to show that all generic drug products are identical to the original drug product and provide the same safe and efficacious response. E) Carbamazepine generic dosage forms are readily substituted for the innovator product because they all provide the same seizure control across all patients.

B) A generic product judged therapeutically equivalent to the reference listed drug will have the same identity, strength, quality, safety, and efficacy

If we know that an unionized form of a weak base (pKa = 4.5) readily permeates a cellular barrier by passive transcellular diffusion, which of the following statements about this drug's oral absorption phenomena will be false: A) The higher the pH, the more likely the drug will be absorbed. B) When the pKa-pH is -3, the drug will show its lowest ability to be absorbed. C) When the pKa-pH is 3, the drug will show its lowest ability to be absorbed. D) In the upper region of the small intestine, the pH is 4.5. At this pH, 50% of the drug is unionized and available for absorption. E) A and C

B) When the pKa-pH is -3, the drug will show its lowest ability to be absorbed.

"ADME" is an acronym. Which of the following terms is not a component of ADME? A) Absorption B) Metabolism C) Digestion D) Excretion E) All of the above are correct components of ADME

C) Digestion

Which of the following statements is FALSE: A) A drug can be directly absorbed into the lymphatic system B) The ascending colon is the primary colonic region for drug absorption C) Gastric emptying is not affected by food D) Small intestinal transit time is unaffected by either the fed or fasted states E) Progenitor cells line the bottom of the crypt region and replicate to replace villus tip cells that have been sloughed off.

C) Gastric emptying is not affected by food

Which of the following statements is false: A) The mouth to anus transit time is approximately 24-32 hours B) The crypt region of the intestinal villi contains progenitor cells, where there are 3x as many crypt regions as there are villi. C) The apical facing membrane in the intestinal enterocyte is very similar to basolateral membrane in composition. D) The presence of folds and microvilli acts to increase the absorptive surface are almost 600 fold E) All statements are true

C) The apical facing membrane in the intestinal enterocyte is very similar to basolateral membrane in composition.

There are several processes that are required for oral absorption of monolithic dosage forms. Which of the following is not a required process? A) Drug molecules at the surface dissolve to form a saturated solution B) Drug molecules diffuse through the bulk solution to the absorbing mucosa and are absorbed C) Replenishment of drug molecules in the diffusion layer is achieved by further dissolution D) Dissolved drug molecules diffuse across the saturated solution layer from the area of low concentration at the surface to high concentration in the bulk solution by flux E) All are required processes

D) Dissolved drug molecules diffuse across the saturated solution layer from the area of low concentration at the surface to high concentration in the bulk solution by flux

The pH partition hypothesis states that: A) Only ionized drug is absorbed B) Both ionized and unionized drug are absorbed C) Neither ionized nor unionized drug is absorbed D) Only unionized drug is absorbed Ionized drugs are degraded in the stomach

D) Only unionized drug is absorbed

The biological membrane plays an important role in governing cell function. Without a membrane, there would not be life. Please select the FALSE statement below regarding the role of biological membranes: A) All living cells are enclosed by one or more membranes, which define the cell as the living unit B) The membrane isolates the cellular contents from the environment-forms a barrier. C) Under normal physiological conditions, the cellular lipid composition is polarized, and intracellular membrane lipids are different then extracellular lipids. D) The lipid composition of all biological membranes is identical. E) The cell membrane is a semi-permeable membrane, permitting the rapid passage of some chemicals while retarding or preventing the passage of others.

D) The lipid composition of all biological membranes is identical.

Tight junctions possess a functional relevancy that is very important to understand when it comes to drug delivery and absorption. Please select the function that is NOT attributed to tight junctions: A) They enable the cell to have functionally different apical and basolateral membranes. B) They play an important role in cell-cell adhesion C) They help to form a "ziplock" like seal around the cells D) They are amphiphilic in nature. E) Restrict solute movement between the cells (paracellular route)

D) They are amphiphilic in nature.

There are several reasons for utilizing enteric coatings including all of the following EXCEPT: A) To delay drug release-control release B) To deliver the drug locally-could be used for lower bowel disorders like Crohn's C) To deliver the drug to an optimal absorption window D) To enhance gastric acid degradation E) To prevent gastric distress from the drug

D) To enhance gastric acid degradation

There are several physiological challenges that make predicting the clinical performance of a dosage form in the clinic hard to do. They include all of the following EXCEPT: A) Variability is enormous in GI fluid composition in patients B) Drug-nutrient and drug-drug interactions are common. C) Diet and chemical exposure varies D) While changes in the individual GI transit times are not common, they do vary widely across different patients. E) Transporters and enzymes vary along the GI tract.

D) While changes in the individual GI transit times are not common, they do vary widely across different patients.

All of the following are examples of dosage forms EXCEPT: A) Transdermal patches B) Orally administered tablets C) Rectal suppositories D) Intravenous solutions E) Cardiac pacemakers

E) Cardiac pacemakers

In class we discussed the concept of performance, which relates to the final drug product (dosage form). Which of the following is not a feature that describes performance: A) The ability of the drug to elicit a therapeutic response B) Described by both Pharmacokinetics and Pharmacodynamic processes C) The ability of the drug to stay in a safe therapeutic range during the dosing regimens D) It is a function of the drug, the formulation and the body-it can be a moving target E) Enables the ability to elicit a toxic or non-efficacious response

E) Enables the ability to elicit a toxic or non-efficacious response

All of the following can reduce the bioavailability of an orally administered drug EXCEPT: A) Poor dissolution in the GI tract B) Chemical degradation in the GI tract C) Metabolism in the liver D) Poor absorption across the GI mucosa E) Poor penetration of the blood-brain barrier

E) Poor penetration of the blood-brain barrier

A typical formulation would not contain a. Filler (MCC) b. Binder (HPMC) c. Complexing agent d. Disintegrant

c. Complexing agent

Amorphous drugs typically give: a. Higher plasma levels than crystalline b. The same blood levels as crystalline c. Lower blood levels than crystalline d. Both a and b are possible

a. Higher plasma levels than crystalline

Which of these compounds would be most difficult to develop as soft-gel liquid filled capsules? a. Hydrocortisone b. Sulfapyridine c. Phenacetin d. Thymol

a. Hydrocortisone

Particle size measurements cannot be made using a. Infrared method b. Sieving method c. Microscopic method d. Coulter counter method

a. Infrared method

The workflow for Merck does not include as a main parameter a. Metabolism b. Initial API phase c. Solid state properties d. Biopharmaceutical properties

a. Metabolism

Tablet problems with the following tablets cause recalls at KV pharmaceuticals a. Morphine sulfate b. Methylphenidate c. Oxycodone d. Oxymorphone

a. Morphine sulfate

Big question(s) for new drug development include a. What is the structure of the compound? b. What is its patent status? c. How will it be distributed? d. a, b, and c

a. What is the structure of the compound?

Risk is: a. combination of the probability of occurrence of harm and the severity of that harm b. generally low in tablet manufacture c. not the subject of FDA guidances d. a, b, and c

a. combination of the probability of occurrence of harm and the severity of that harm

The pharmaceutical you dispense to a patient is also called: a. drug product b. drug substance c. API d. Excipient

a. drug product

Particle size does not affect a. Dissolution rate b. True density c. Grittiness of ointments d. Suspendability of suspensions

b. True density

The pH partition hypothesis states that: a. Only ionized drug is absorbed b. Both ionized and unionized drug are absorbed c. Only unionized drug is absorbed d. Ionized drugs are degraded in the stomach

c. Only unionized drug is absorbed

A compound that always requires metabolic biotransformation after administration to produce the desired pharmacologically active compound is a a. Goal drug b. Natural product c. Pro drug d. Salt

c. Pro drug

Enteric coated tablets a. Release in the stomach b. Release at pH 1 c. Release in the intestine d. Release in the esophagus

c. Release in the intestine

Which is not a step in filling capsules a. Step 1. Rectification: The empty capsules are oriented so that all point the same direction b. Step 2. Separation of caps from bodies c. Step 3. Rotation of the capsule d. Step.4. Replacement of caps and ejection of filled capsules:

c. Step 3. Rotation of the capsule

cGMP for finished pharmaceuticals does not include a. Organization and personnel b. Buildings and facilities c. Supply chain d. Control of components, containers, and closures

c. Supply chain

KV pharmaceuticals experienced large decreases in: a. Number of employees (workforce) b. Stock value c. Size of physical facilities d. Both a and b

d. Both a and b

Noncompliance with GMP can result in: a. Delay of approval b. Forced sale of the company c. Removal of violative products d. Both a and c

d. Both a and c

The quality of tablets is controlled by a. Measuring the amount of binder b. Measuring hardness c. Measuring dissolution d. Both b and c

d. Both b and c

Which is a cardinal rule of drug development a. Understand the supply chain b. Know what you have c. Make the same thing every time d. Both b and c

d. Both b and c

Which of the following tablets are used to provide almost immediate blood levels for instant pain relief. a. Compressed tablets b. Sugarcoated tablets c. Film-coated tablets d. Buccal or sublingual tablets

d. Buccal or sublingual tablets

Which is not a goal for design of medicines a. Reduce time to market (and clinical supplies) b. Be able to ensure equivalence/sameness with later manufactured drug substance (API) and drug product c. Achieve quality by design d. None of the above (all of the above are goals)

d. None of the above (all of the above are goals)

Which is not true about Ritonavir and the Ritonavir story a. Originally a soft gel was marketed b. Nothing could prevent the crystallization c. Abbott had to withdraw the formulation and market a new formulation d. The cost was estimated at $10 billion dollars

d. The cost was estimated at $10 billion dollars

Which compound would be the least difficult to develop as soft-gel liquid filled capsules? a. Hydrocortisone b. Sulfapyridine c. Benzocaine d. Thymol

d. Thymol

Parameters important in preformulation include a. Drug solubility b. Partition coefficient c. Dissolution rate d. a, b, and c

d. a, b, and c

USP and NF monographs cover a. Drug substances b. Pharmaceutical ingredients c. Dosage forms d. a, b, c

d. a, b, c

Drug development involves a. Making a molecule into a medicine b. Making a stable medicine c. Making a manufactuable medicine d. a., b., and c.

d. a., b., and c.