Part 3

Question 1

What is a treatment IND?

Answer 1

A treatment IND permits the use of an investigational drug for the treatment of patients who aren’t enrolled in the clinical study but have severe life-threatening disease for which there is no available treatment.
For products to be considered for this, the drug MUST be under active investigation in a controlled clinical trial with sufficient evidence of its safety and efficacy for use in the intended patients

Question 2

What is an orphan drug?

Answer 2

a rare disease that effects fewer than 200,000 people in the United States

Question 3

Can a sponsor withdraw an IND at any time?

Answer 3

YES

Question 4

Explain a normal distribution sample for dosage of a drug

Answer 4

a normal distribution sample for drug dosage is a bell curve. An “average” effect will be produced in most people. However, a portion of the population will experience an effect greater than average or little effect.

Question 5

For sensitive individuals, will they fall on the right or left side of the bell curve

What about resistant individuals?

Answer 5

sensitive patients will experience a greater than average effect on the average dosage of a drug. Therefore, they will fall more to the right side of a bell curve

Resistant individuals will experience little effect and will fall on the left side of the bell curve

Question 6

What do MEC and MTC stand for and what graph are they found on

Answer 6

MEC — minimum effective concentration

MTC — Minimum toxic concentration

found on “drug profile in systemic circulation” graph

Question 7

To provide systemic effects, a drug must….

Answer 7

-be absorbed from its route of administration at a suitable rate

-be distributed in adequate concentration to its receptor sites

-remain at the receptor sites for a specific period

Question 8

What is a measure of a drug’s absorption characteristics?

Answer 8

its blood serum concentration at various intervals after the drug’s administration

Question 9

Describe further what MEC means

Answer 9

minimum effective concentration
= the minimum concentration that can be expected to produce the drug’s desired effect in a patient

Question 10

Any value of serum concentration above MEC has…

Answer 10

therapeutic effect

Question 11

If a drug takes 2 hours after administration to reach MEC, and falls back to MEC 10 hours after administration, when should the 2nd dose be taken if it were desired to maintain the drug serum concentration above MEC for a longer period

Answer 11

2nd dose should be taken at hour 8 after administration

Question 12

Explain further what MTC means

Answer 12

MTC— Minimum toxic concentration

If the blood serum concentration goes higher than MTC, dose-related toxic effects would occur in the average individual

Question 13

We want the serum-drug concentration to be….

Answer 13

between MEC and MTC for the desired effect period

Question 14

After a drug is taken, is it immediately available in the body?

Answer 14

no - it takes time

Question 15

What can you say about a drug that has a low lethal dose

Answer 15

it is closely monitored. takes only a small amount of ingestion for the drug to be lethal to the patient

Question 16

Why is acetaminophen not monitored?

Answer 16

because the lethal dose and even the toxic dose is very high

Question 17

Drug substance concentration can be measured in ___ or ___

Answer 17

mcg/mL mg/mL etc

Question 18

At the time of submitting an NDA, you must include a proposed…….

Answer 18

PACKAGE INSERT

Question 19

name everything that must be included in the proposed package insert (11 things)

Answer 19

-description
-clinical pharmacology
-indications and usage
-contraindications
-warnings
-precautions
-adverse reactions
-drug use and dependence
-overdosage
-dosage and administration
-how supplied (available dosage forms, strengths, NDC’s)

Question 20

What does NDC stand for

Answer 20

national drug code

Question 21

The FDA must respond to an NDA within _____ days of receipt of an application

Answer 21

180

Question 22

If an FDA sends an action letter of approval of an NDA, what happens next?

Answer 22

the product is marketed and phase 4 of clinical trials is conducted. Postmarketing surveillance

Question 23

After a drug has hit the market (NDA has been approved) what must the sponsor do

Answer 23

-the drug’s sponsor is required to report each drug experience that is both serious and unexpected within 15 days.

-Other adverse events are reported quarterly for 3 years following approval and yearly thereafter

Also, the drug’s sponsor must submit annual reports each year

Question 24

What do SNDA and ANDA stand for

Answer 24

SNDA — supplemental new drug application

ANDA – Abbreviated new drug application

Question 25

Explain the circumstances in which a SNDA (SUPPLEMENTAL NDA) is submitted

Answer 25

A drug that has ALREADY had an approved NDA. sponsor must submit an SNDA if... -they change the method of synthesis of the drug -different facility to manufacture -change in formulation -change in the container -extension of the expiration date of a product based on new stability data -any labeling change that doesn't add to or strengthen a PREVIOUSLY APPROVED label statement

Question 26

A company with a previously approved NDA is changing the container for their product. does an SNDA need to be submitted?

Answer 26

YES --- if they're simply changing the SIZE of the container and not the type of container, then SNDA does not need to be submitted

Question 27

A company is extending the expiration date on a product with an approved NDA. Does an SNDA need to be submitted?

Answer 27

it depends If the expiration date is being lengthened due to NEW STABILITY DATA, then the SNDA does have to be submitted if the expiration date is being lengthened based on full shelf-life data obtained from a protocol in the APPROVED application, then it is not required

Question 28

a company is changing the label on a product that has an approved NDA. Does an SNDA need to be submitted?

Answer 28

it depends SNDA DOES NOT NEED TO BE SUBMITTED IF.. they are minor editorial changes to add or strengthen an already approved label section SNDA NEEDS TO BE SUBMITTED: if the labeling change does not add to or strengthen a previously approved label statement

Question 29

When is an ANDA (abbreviated NDA) submitted

Answer 29

For duplicates (generics) of drug products previously approved

Question 30

Single dose definition

Answer 30

the amount taken at 1 time

Question 31

Total dose definition

Answer 31

the total amount taken during the course of therapy

Question 32

Daily dose can be divided into...

Answer 32

divided doses --- two or more times a day

Question 33

What is the dosage regimen

Answer 33

the schedule of dosing (ie: 4 times a day for 10 days)

Question 34

Where can the usual adult dose be found?

Answer 34

PDR

Question 35

What is the median effective dose of a drug

Answer 35

the amount that produces the desired intensity of effect in 50% of individuals tested

Question 36

What is the median toxic dose of a drug

Answer 36

the amount of a drug that produces toxic effects in 50% of individuals testd

Question 37

What is the MEC

Answer 37

minimum effective concentration --- the minimum blood serum concentration of a drug that can be expected to produce the drug's desired effect

Question 38

What is MTC

Answer 38

minimum toxic concentration-- the base level of blood serum concentration that produces dose-related toxic effects

Question 39

What does priming/loading dose mean

Answer 39

for certain drugs, a larger than usual initial dose may be required to achieve the desired blood drug level. This larger than usual initial dose is called the loading/priming dose

Question 40

What are maintenance doses

Answer 40

maintenance doses are those that are similar in amount to usual doses, and are administered after the loading dose to sustain the desired blood drug levels for optimal drug effects

Question 41

What are prophylactic doses?

Answer 41

those that are designed to prevent a disease from occuring ie: vaccines, aspirin

Question 42

What are therapeutic doses?

Answer 42

those that are administered to counter a disease after exposure. ie: anitoxins -- antibodies to neutralize a toxin

Question 43

USP DI is designed for..

Answer 43

patient and the pharmacist Equivalent to PDR --- designed for physicians

Question 44

1 tablespoon = ___mL 1 teaspoon = ____ mL

Answer 44

1 tablespoon - 15 mL 1 teaspoon - 5mL