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Pharmaceutics Exam 1 > Part 2 > Flashcards

Part 2 Flashcards

1
Q

What is the difference between USP/NF and PPI

A

USP is telling about individual compounds used to PRODUCE product. it is not the product itself. (ie: the compound amoxicillin)

PPI is information about the FINAL PRODUCT (the trade name. ie: amoxil)

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2
Q

A generic API would be shown on a….

A

USP/NF

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3
Q

What does NDA and IND stand for? Which is submitted first?

A

NDA= new drug application
IND= Investigational New Drug

IND is submitted first

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4
Q

When is an IND application submitted?

A
  1. new chemical entity discovered (API)
  2. Preclinical studies

THEN THE IND APPLICATION IS SUBMITTED AND REVIEWED BY THE FDA

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5
Q

Name 5 sources of a new chemical entity

A

-organic synthesis
-molecular modification
-isolation from plants
-extraction from animal tissue
-genetic engineering

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6
Q

Define further what “preclinical studies” means.

What happens after the preclinical studies are conducted?

A

preclinical studies is finding out the chemistry, physical and biological properties of the drug. ex: the pharmacology, the ADME, and the toxicology.
Preformulation

AFTER THE PRECLINICAL STUDIES ARE CONDUCTED, AN IND IS SUBMITTED AND REVIEWED BY THE FDA

PRECLINICAL STUDIES CONTINUE WHILE THE IND IS BEING REVIEWED:

-long term animal toxicity
-product formulation
-manufacturing and controls
-package and label design

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7
Q

When do clinical trials start being conducted?

A

phases 1-3 are conducted after the 30 day wait period after the IND is submitted

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8
Q

When is an NDA submitted?

A

After an IND has been approved by the FDA and phases 1-3 of clinical trials have been completed. All preclinical studies are complete

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9
Q

If the FDA approves an NDA, what is happening after the drug hits the market? (postmarketing)

A

-PHASE 4 CLINICAL STUDIES
(ie: clinical pharmacology/toxicology)

-adverse reaction reporting
-product defect reporting
-product line extension

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10
Q

WHERE are preclinical studies taking place?

A

in the setting of the company who discovered the new chemical entity (API)

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11
Q

When are issues like solubility of the API handled?

A

during preclinical studies

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12
Q

how long does the FDA take to review an IND? What happens if the FDA rejects an IND?

A

30 days
if the FDA rejects it, the company has to stop phases 1-3 of the clinical trials

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13
Q

How long does the FDA take to review and approve an NDA?

A

around 11/2 years

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14
Q

approximately how long does a drug take to be discovered and then finally hit the market

A

preclinical — 61/2 years
clinical —– 7 years
NDA review —- 11/2 years

approximately 15 years

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15
Q

What does the term “goal drug” mean

A

goal drug refers to a drug that has a good ADME (absorption, distribution, metabolism, excretion), no side effects, and good solubility without any modifications.

The “goal drug” is not yet discovered

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16
Q

In today’s age, are more drugs discovered or modified?

A

modified and designed. all the drugs that were “easy” to discover have already been discovered over the years

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17
Q

Name some methods of drug discovery

A

-random screening (luck)
-non-random screening
-biologic assays (not worried abt ADME–just if goal is accomplished)
-molecular modification
-mechanism-based drug design

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18
Q

What is a lead compound

A

a chemical compound that has pharmacological/biological activity but has suboptimal structure that requires it to be modified to fit better to the target

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19
Q

What are prodrugs?

A

prodrugs are inactive substances that do NOT HAVE THERAPEUTIC EFFECT. they are not drugs.

Prodrugs become biotransformed in the body to become a drug and gets activated

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20
Q

Are prodrugs drugs?

A

NO- they become drugs once they enter the body

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21
Q

What is the FDA’s definition of a new drug

A

-new formulation
-new manufacturing method
-new combination of drugs
-new indication for use. etc

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22
Q

Name 3 names of a drug

A

-generic name
-trade name
-empirical formula; synthetic chemical name; code number

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23
Q

The “name brand” of a medication could also be called the…

A

trade name

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24
Q

The generic name of a drug could also be referred to as the….

A

nonproprietary name

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25
Q

Who determines the generic/nonproprietary name of a drug?

A

USAN Council (United States adopted names council)

26
Q

Name 3 branches of biological characterization of drugs

A

-Pharmacology
-Drug Metabolism
-Toxicology

27
Q

Explain the biological characterization, “Pharmacology” further

A

pharmacokinetics and pharmacodynamics

pharmacokinetics = ADME

pharmacodynamics = mechanism of action, biochemical and physiological effects (therapeutic effect)

Clinical pharmacology

28
Q

Give a subcategory of drug metabolism

A

First pass effect — Drug gets reduced in concentration (degraded by liver enzymes) before it can reach the site of action or systemic circulation

29
Q

What are the 2 main concerns of toxicology

A

Carcinogenicity studies and reproduction studies

30
Q

What are some lesser studies of toxicology (not carcinogenic or reproductive)

A

acute/short term toxicity studies
subacute/subchronic studies
genotoxicity/ mutagenicity studies

31
Q

Explain the difference between acute, subacute and subchronic toxicology studies

A

acute — investigating the adverse events of a substance that result either from a single exposure or multiple exposures in a short period of time

subacute — investigating the effects of a drug following a treatment period of 2-4 weeks

subchronic – investigating the effects of a drug when taken from 90 days-12 months

32
Q

Name 5 things that are determined in preformulation studies

A

-Drug solubility
-Partition coefficient
-Dissolution rate
-Physical form
-Stability

33
Q

What will happen if a drug is not soluble in water

A

it most likely won’t have therapeutic effect
resolution = cosolvent

34
Q

The partition coefficient is related to….

A

how much of the drug will cross the lipid membrane.

we want a 1:1 ratio

35
Q

Which has a higher energy — crystalline form or amorphous form

A

AMORPHOUS — this higher energy means it has a better solubility

36
Q

If a drug changes physical form, is this considered a new drug to the FDA?

A

YES (ie: crystalline to amorphous)

37
Q

Amoxil contains…

A

the compound amoxicillin and inactive ingredients

38
Q

Name things that can be found on a USP/NF monograph

A

Chemical name
Chemical structure
Cas #
Molecular weight (hydrous/anhydrous)
assay method
drug standard
packaging
storage

39
Q

Does a USP/NF monograph contain information about the therapeutic effect of the compound?

A

NO!
This info is on “amoxil” handout. “physician’s desk reference”

USP/NF is not concerned with therapeutic effect, just with the compound itself (the pure API)
NOT the drug

40
Q

Will a USP/NF contain pharmacology/microbiology information?

A

NO

41
Q

What information can you find on PDR/PPI

A

-info related to the final PRODUCT
-brand name
-API
-description
-structure
-action (pharmacology)
-NDC #’s (NOT CAS NUMBER)

ALL INFO RELATED TO CLINICAL PRACTICE

42
Q

Does the PDR contain the structure of the API

A

yes! both PDR and USP/NF contain the structure

43
Q

Can the chemical name be found on a PDR

A

no – only the structure

44
Q

Where can the inactive ingredients be found

A

PDR

45
Q

Who reviews the IND of a DRUG

A

a division of the FDA called CDER
(center for drug evaluation and research)

46
Q

Who reviews the IND of a new VACCINE

A

CBER
(center for biologics evaluation and research)

47
Q

If an approved drug is converted to its salt or ester form, is it considered a new drug by the FDA?

A

YES

48
Q

Explain thoroghly phase 1 of a clinical trial.
Include:
-# of patients
-length
-purpose
-% of drugs that successfully pass

A

phase 1…
# patients = 20-100
length: up to 1 year
purpose: mainly safety
% of drugs successfully passed = 70%

49
Q

Explain thoroughly phase 2 of a clinical trial
include:
-# of patients
-length
-purpose
-% of drugs that pass

A

phase 2….

patients = 100-500
length = several months-2 years
purpose: some short term safety, but mainly effectiveness
% of drugs successfully passed = 33%

50
Q

Explain thoroughly phase 3 of a clinical trial
include..
-# of patients
-length
-purpose
- % of drugs successfully tested

A

phase 3…

patients = 1,000-5,000
length = 1-4 years
purpose = safety, effectiveness, dosage
% of drugs that pass = 25-30%

51
Q

In which phase of clinical trials do we start to think about information that must be put in the package insert? (ie: pharmacology, dose, etc)

A

phase 2 – package insert is finalized in phase 3

52
Q

Which phase of clinical trials is the easiest to pass

A

phase 1

53
Q

When will the drug’s sponsor file an IND

A

only after….

-the preclinical studies demonstrate adequate safety
-the new agent shows promise as a useful drug

54
Q

In phase 1, the 20-100 subjects are usually…

A

healthy patients. but in some cases they may have the disease

55
Q

In which phase do we start using patients as subjects and not healthy individuals

A

phase 2

56
Q

When do we like to use crossovers in clinical trials

A

when our test subjects are different (ie: different ages) to avoid getting false results

57
Q

Explain the difference between a single crossover with/without an intervening baseline

A

single crossover without baseline —- 2 different groups exist. (ie: 1 group is in theyr 20s one is in their 50s) to avoid results being false due to natural comorbidities, the 2 groups are given consecutive alternative treatments.

for example.. for 1 month group A will receive the current standard of care and at the same time treatment B will get the new drug being tested. After 30 days, the groups will immediately swap treatments if there is no baseline

for a single crossover WITH a baseline, it is the same concept except there is a “baseline” (waiting) period for the previous drug to completely leave the body before switching treatments to avoid errors

58
Q

what is an extra period crossover

A

in an extra period crossover, group A is given the current treatment and group B is given the tested treatment. After a certain period of time, they swap treatments immediately. (no baseline)

This second treatment is repeated for another se period (whatever it may be.. 30 days etc) to confirm results

59
Q

Name the 4 components of the dose regimen

A

-form
-route of administration
-dose
-time and conditions of administration

60
Q

Name some factors affecting the dose of a drug

A

-age
-pharmacogenetics
-body weight
-BSA (body surface area)
-sex
-pathologic state (ie: renal impairment)
-tolerance
-concomitant drug therapy (2 drugs given @ same time)
-time and conditions of administration
-dosage form and route of administration

61
Q
A

Pharmaceutics Exam 1 (8 decks)

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