Drug Dev. & approval process (FINAL)

Question 1

What is pharmaceutics?

Answer 1

The art, science, and technology of dosage form design (preparing and dispensing drugs).

Question 2

What are the physiochemical properties of a drug?

Answer 2

stability, ionization, water/lipid solubility, hydrolysis, oxidation, racemization, etc.

Question 3

What are the biological properties of a drug?

Answer 3

absorption, transportation, biotransformation, etc.

Question 4

Name 3 common dosage forms.

Answer 4

capsule, tablet, solution.

Question 5

Why are drugs expensive?

Answer 5

takes 10-15 years to develop one new medicine, costing $800 million to $1 billion.

Question 6

What agency is responsible for drug approval in the U.S.?

Answer 6

FDA.

Question 7

What is the role of the Center for Drug Evaluation and Research (CDER)?

Answer 7

approves drugs based on safety and effectiveness.

Question 8

What is a New Chemical Entity (NCE)?

Answer 8

a drug that has never been approved for use.

Question 9

What is the IND application?

Answer 9

investigational new drug application submitted for FDA review before clinical trials.

Question 10

How long does preclinical research and development typically take?

Answer 10

approximately 3-6 years.

Question 11

What happens during Phase I clinical trials?

Answer 11

assessing safety in 20-100 healthy volunteers.

Question 12

What us the primary goal of Phase II clinical trials?

Answer 12

to evaluate effectiveness in several hundred patients.

Question 13

How many patients are involved in Phase III clinical trials?

Answer 13

several hundred to several thousand patients.

Question 14

What is the purpose of a New Drug Application (NDA)?

Answer 14

to gain permission to market the drug product in the U.S.

Question 15

What is Phase IV study?

Answer 15

Post-marketing studies revealing additional side effects and drug interactions.

Question 16

Why are dosage forms important?

Answer 16

patients take dosage forms, not drugs; they ensure safe and accurate delivery.

Question 17

What are the main routes of administration?

Answer 17

oral, parenteral, topical, transdermal, ocular, etc

Question 18

Classify dosage forms based on release rate?

Answer 18

fast action, conventional, sustained, pulsatile.

Question 19

Name a solid dosage form.

Answer 19

tablets.

Question 20

Name a liquid dosage form.

Answer 20

syrups.

Question 21

What is the usual dose and onset of action for sublingual nitroglycerin?

Answer 21

0.3-0.8 mg; onset: 2-5 mins.

Question 22

What is the peak action time for oral nitroglycerin?

Answer 22

45-120 mins.

Question 23

What is the duration of action for transdermal nitroglycerin patches?

Answer 23

Up to 24 hrs.

Question 24

What are the primary dosage forms for parenteral administration?

Answer 24

solutions, suspensions.

Question 25

What types of formulations are used for ocular administration?

Answer 25

solutions, sprays, ointments.

Question 26

What is the FDA’s response time for an IND application?

Answer 26

30 days.

Question 27

What are the stages of preclinical research?

Answer 27

Pre-discovery, discovery, preclinical studies.

Question 28

How many years does clinical research and development typically take?

Answer 28

6-7 years.

Question 29

What is assessed during Phase I clinical trials?

Answer 29

safety and tolerability of a drug.