Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Pharmaceutics Exam 1 > Part 3 > Flashcards

Part 3 Flashcards

1
Q

What is a treatment IND?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is an orphan drug?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Can a sponsor withdraw an IND at any time?

A

YES

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Explain a normal distribution sample for dosage of a drug

A

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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

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

What about resistant individuals?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

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

A

MEC — minimum effective concentration

MTC — Minimum toxic concentration

found on “drug profile in systemic circulation” graph

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

To provide systemic effects, a drug must….

A

-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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

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

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Describe further what MEC means

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Any value of serum concentration above MEC has…

A

therapeutic effect

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

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

A

2nd dose should be taken at hour 8 after administration

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Explain further what MTC means

A

MTC— Minimum toxic concentration

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

We want the serum-drug concentration to be….

A

between MEC and MTC for the desired effect period

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

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

A

no - it takes time

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

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

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Why is acetaminophen not monitored?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Drug substance concentration can be measured in ___ or ___

A

mcg/mL mg/mL etc

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

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

A

PACKAGE INSERT

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

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

A

-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)

20
Q

What does NDC stand for

A

national drug code

21
Q

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

A

180

22
Q

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

A

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

23
Q

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

A

-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

24
Q

What do SNDA and ANDA stand for

A

SNDA — supplemental new drug application

ANDA – Abbreviated new drug application

25
Q

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

A

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

26
Q

A company with a previously approved NDA is changing the container for their product.

does an SNDA need to be submitted?

A

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

27
Q

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

A

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

28
Q

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

A

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

29
Q

When is an ANDA (abbreviated NDA) submitted

A

For duplicates (generics) of drug products previously approved

30
Q

Single dose definition

A

the amount taken at 1 time

31
Q

Total dose definition

A

the total amount taken during the course of therapy

32
Q

Daily dose can be divided into…

A

divided doses — two or more times a day

33
Q

What is the dosage regimen

A

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

34
Q

Where can the usual adult dose be found?

A

PDR

35
Q

What is the median effective dose of a drug

A

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

36
Q

What is the median toxic dose of a drug

A

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

37
Q

What is the MEC

A

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

38
Q

What is MTC

A

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

39
Q

What does priming/loading dose mean

A

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

40
Q

What are maintenance doses

A

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

41
Q

What are prophylactic doses?

A

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

42
Q

What are therapeutic doses?

A

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

43
Q

USP DI is designed for..

A

patient and the pharmacist
Equivalent to PDR — designed for physicians

44
Q

1 tablespoon = ___mL
1 teaspoon = ____ mL

A

1 tablespoon - 15 mL
1 teaspoon - 5mL

45
Q
A

Pharmaceutics Exam 1 (8 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions