Quiz 1 Material Flashcards
A branch of pharmaceutics that study the fate of drugs after administration to a living organism.
Pharmacokinetics
The study of drug concentration and it’s effect to the body.
Pharmacodynamics
Study of the impact of physicochemical properties of the drug and drug product on drug delivery and absorption under normal or pathological condition.
Bio-pharmaceutics
The influence of genetic variation on a drugs efficacy and toxicity
Pharmacogenomics
The technologies involving development of dosage forms
Pharmaceutical Technology
Pharmaceutics deals with all of the following except?
A. Preparation of dosage forms
B. Formulating a pure drug to dosage forms
C. Studying the physico-chemical properties of pure drug substance
D. Identifying the mechanism of action of a drug
E. Study the rate and extent of drug absorption
D. Identifying the mechanism of action of a drug
A substance used in the diagnoses, mitigation, treatment, cure, or prevention of disease in humans or other animals.
Drug
A drug that must change to an active compound after ingestion. Such conversion occurs through enzymatic and biochemical cleavage.
Pro-drug
In non-clinical development are humans involved or not?
No, non-human status
In clinical development are studies performed in humans?
Yes
A protein, enzyme, receptor, signaling, or other molecules that is/are responsible for development of a disease.
Target
A test protein, peptide, or compound that appears to act on targets.
Hit
Of the numerous hits or variants, the protein, peptide, or organic compound that show the highest degree of activity against the disease.
Lead
A protein, peptide, or organic compound that has most or all of the properties of a desired therapeutic agent.
Candidate
New Drug application, filed for initial testing of each new drug in humans.
Investigational New Drug Application
A marketed therapeutic agent
Product
First studies in humans, usually healthy humans, after obtaining IND. Single dose followed by short-term multiple dose studies - follow up for days to weeks.
Clinical Development Phase I
Determine effectiveness in conditions or diseases of interest.
Clinical Development Phase II
Confirm effectiveness in larger studies
Clinical Development Phase III
Post-approval studies
Clinical Development Phase IV
It takes about ___ years to develop a FDA approved brand name drug.
15
What kind of drug does not require preclinical development or the drug discovery process? What does this kind of drug require?
Generic Drugs
Bioequivalence study
Preclinical studies are performed in _________.
Animals
Clinical studies are performed in _______ at _______ different phases
Humans
Four
An active ingredient that produces pharmacological action or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease. Does this include the intermediates used in the synthesis of such ingredient?
Drug substance
No
A finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally but not necessarily, in association with one or more other ingredients.
Drug Product
An amount of drug that is enough to produce a therapeutic response without producing toxic effects
Dose
Which of the following statements are not correct?
A. Drug substance is the same as active ingredient
B. Tablet is a drug product
C. The terms ‘drug product’ and ‘drug substance’ can be used interchangeably
D. Prodrugs requires bio-transformation to become active
E. ‘Dose’ and ‘Dosage forms’ are used as synonyms
A. Drug substance is the same as active ingredient
D. Prodrugs requires bio-tansformation to become active
A dosage form offers which of the following advantages?
A. Provides a safe and vonvenient means of administering a drug
B. Enhances patient compliance
C. Protects the drug against chemical decompostiion
D. Conceals any unpleasant odor or taste
E. Ensures or controls the release of drug into the body
F. All of the above
F. All of the above
Identify the correct statement:
A. Some prescription drugs may not require FDA registration
B. Phase III trial is performed after FDA approval of a drug
C. Generic drug development involves all the steps that are required for a brand drug
D. Mutagenicity studies are performed in healthy humans.
B. Phase III trial is performed after FDA approval of a drug
What information does a dosage form include?
- Name and quantities of ingredients
- Mixing sequence
- Processing steps
Additives in a pharmaceutical formulation.
Excipients
Physical-chemical properties of the drug substance
Drug Factors
Factors that affect absorption of a drug substance from various routes of administration
Bio-pharmaceutic considerations
Ingredient responsible for pharmacological effects
Active Ingredients
Ingredients that do not have any pharmacological effects.
Inactive ingredients
A trademark officially registered by a company.
Proprietary (Brand) Name
The generally recognized or “common” name for a drug.
Non-proprietary (Generic) Name
A copy of a brand drug product, comprising the same active ingredient(s), strength, and dosage form
Generic Product
Identify true or false statements.
A. Proprietary name is the chemical name of a drug
B. The terms, ‘generic name’ and ‘generic product’ describe the same nomenclature
C. Generic name is the common name of a drug
D. Generic product is an imitation of a brand product
A. - False
B. - False
C. - True
D. - True
Not considered dangerous for self-medication and you get these drugs without a prescription.
Over the Counter Drugs
Refills have to be authorized and can only be dispensed with a prescription.
Legend Drugs (prescription)
Drugs that have potential for abuse.
Controlled or Scheduled Drugs
Drugs with no accepted medical use and high potential for abuse.
Schedule I
Drugs with accepted medical uses but still have high potential for abuse. Causes severe psychological and physical dependence.
Schedule II
These substances have an abuse potential less than those in schedule I and II. Can cause moderate or low physical dependence or high psychological dependence.
Schedule III
Less potential for abuse than I, II, III. Causes limited psychological and physical dependence
Scedule IV
Least potential for abuse
Schedule V
Which of the following drug class has the least potential for abuse? A. Schedule I B. Schedule II C. Schedule III D. Schedule IV C. Schedule V
C. Schedule V
Organized sets of monographs or books that describe the standards for drugs.
Pharmacopeias
True or False? Offical compendia considered the legal standard for drugs.
True
True or False? USP is a reference book that establishes standards to be used by manufacturers to prepare drug products.
True
True or False? USP is an independent, science-based public health organization.
True
True or False? Monographs of drug substances are in the USP section and that of pharmaceutical ingredients are in the NF section.
True
True or False? USP is the only pharmacopeia in the world.
False
True or False? USP is used only in the United States.
False
True or False? Monographs of USP mainly describes use of drugs.
False
Drug administered by mouth, and tube feeding using nasogastric, gastrotomy, jejunostomy tubes.
Enteral Route
Drugs administered by the mouth and the drug is absorbed by the GI tract.
Oral Route
Where are oral drugs absorbed mainly?
Small Intestine
What are the advantages to the oral route of administration?
- Convenient and noninvasive
- Good for ambulatory patients
- Self-administration
What are the disadvantages to the oral route of administration?
- Not suitable for drugs that degrades in the GI tract
- First-pass metabolism reduces drug absorption
- Interaction with the GI tract and food
- Unpleasant taste
Solid dosage forms prepared by compression and contain medicinal substances
Tablets
Solid dosage forms in which drug substances and appropriate excipients are enclosed in either hard or soft shell
Capsules
Solid drug particles dispersed in a suitable vehicle
Suspensions
When drugs are present in a homogenous solution
Solutions
Looks like a capsule but is actually a tablet
Caplet
Drug is placed under the tongue
Sublingual region
The drug is held between the cheek and gingivae adjacent to the teeth
Buccal region
What are the advantages to sublingual and buccal routes of administration?
- Avoids first-pass metabolism and GI tract degredation
- Can be used in unconscious patients
What are the disadvantages to sublingual and buccal routes of administration?
- Not very pleasant
- Not good for drugs that are degraded in saliva
What is it called when orally administered drugs enter the liver before entering the systemic circulation?
First-pass metabolism
Routes of administration other than the oral route that are sterile, pyrogen free preparations called injections
Parenteral route
What are the advantages of parenteral routes?
- Used in emergency situations, uncooperative, or unconscious patients
- Unreliable absorption from the GI tract
- Inactivation or destruction from GI tract
What are the disatvantages of parenteral routes?
- Difficult to withdraw and prepare
- Must be sterile
Injected into the corium, the more vascular layer of the skin, just beneath the epidermis.
Intradermal injections
What is a common site of intradermal injections?
The anterior surface of the forearm
Injected into the loose interstitial tissue, the layer of fat immediately under the skin.
Loose interstitial tissue
What are some common sites of interstitial injections?
- The outer surface of the upper arm
- The anterior surface of the thigh
- The lower portion of the abdomen
Injections deep into the skeletal muscles at sites away from nerve and blood vessels
Intramuscular injections
What are the common sites of intramuscular injections?
- Buttocks
- Upper arms
- Lateral thighs
Drugs administered via the large proximal veins in the large proximal veins in anterior surface of elbow, back of hand, and larger veins in the foot.
Intravenous injections
