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Pharm 1
Ceutics 1
Pharm 2
Ceutics 2
Pharmaceutics
100

What is the FDA's definition of a new drug?

  • A new molecular entity (NME) is defined by the FDA as an active ingredient that has never before been marketed in the United States in any form
  • Anything that may cause a change in efficacy or safety would make a product considered ‘new’ under the law
100

What are the two most common sites with which we measure drug amount/ concentration?

Plasma and urine concentration

100

What is the difference between quantitative and qualitative?

Quantitative is number based and qualitative is interpretation based

100

What route of administration describes sublingually?

Under the tongue 

100

What is half-life?

time required for drug in the plasma to decrease by 50%

200

What is the difference between systemic and non-systemic?

Systemic - All over the body

Within body fluids

Within cells

Embedded in cell membranes


May also be non-systemic

Skin

GI-tract

200

What is meant by orphan drug?

  • May also be a treatment IND
  • FDA provides grants to support
  • Extended patent life
200

What is ANDA?

Abbreviated NDA

This process happens when a drug is available for another company to make a generic form of it. This means the the med has gone through the full NDA and the FDA determined the information on the exempted and non clinical studies is already available to the agency

200

What is SNDA?

Supplemental New Drug application (SNDA) 

  • This is done when there are minor changes to the drug such as the formulation of the drug its self
200

What is volume of distribution?

how well the drug is distributed in the body

300

What is bioavailability?

(percent or fraction) of a dose of unchanged drug that reaches systematic circulation

300

What is pharmaceutics?

examines physiochemical properties of drugs and dosage forms

300

What is pharmacokinetics?

studies movement of drugs within the body

300

What is biopharmaceutics?

examine interrelationship between properties of drugs, dosage forms, and the route of administration

300

What is clearance?

volume of plasma cleared of drug per unit time

400

What is NDA?

New Drug Application (a comprehensive document)



400

What information can be found in USP/NF?

Monographs for drug substances, dietary substances, dosage forms, and compounded preparations

(Standards include strength, purity, quality, and packaging and labeling)

400

What is the FDA's stance of dietary supplements?

They are not legally considered drugs if they have not been submitted for review on NDA’S and haven’t been evaluated for safety and efficiency by the FDA however their proper usage is a concern.


400

What does NDC stand for and what are the components?

  • First 5: manufacturer
  • Next 4: dosage form/ route of administration
  • Last 2: packaging size
400

What is the IND?

Investigational New Drug Application (IND) 

  • Required to be submitted to FDA before human trials
  • Company must wait 30 days after FDA acknowledges receipt of IND to begin trials
  • FDA may put “Clinical Hold” on study if it has concerns
500

What are the components of LADME and describe them?

Liberation (release of the drug), Absorption (absorbed through the bloodstream), Distribution (distributes to various parts of the body) , Metabolism (by enzymes), and Excretion (through the kidneys or other routes). 

500

What are the three classes of drug recalls? (Explain) 

  • Class I: There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
  • Class II: The use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
  • Class III: The use of or exposure to a violative product is not likely to cause adverse health consequences.
500

What are the differences between the five scheduled drug classes?

  • Schedule 1: drugs with no medical use
  • Schedule 2: drugs with accepted medical use/ or substance with high potential for abuse
  • Schedule 3: drugs with accepted medical use/ potential for abuse less than schedule 1 & 2
  • Schedule 4: drugs with accepted medical use/ low potential for abuse compared to schedule 3
  • Schedule 5: drugs with accepted medical use/ low potential for abuse
500

What are the differences between phases 0 and 4?

  • Phase 0: very limited patients before escalation and tolerability studies
  • Phase 1 still a small amount of people mainly about safety
  • Phase 2 more people and about safety and effectiveness
  • Phase 3 most people focus on safety, effectiveness, and dosage
  • Phase 4 marketing and advertising 
500

What are the required elements of drug labeling?

Required portions of package insert

  • Description of product – physical chemical properties
  • Clinical Pharmacology = mechanism of action, PK, Biopharm
  • Indication and usage
  • Contraindication 

Portions of the drug label

  • Precautions
  • Adverse reaction
  • Drug abuse and dependence
  • Over dosage
  • Drug and administration
  • How supplied