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Pharmacology > Drug Development And Approval Process > Flashcards

Drug Development And Approval Process Flashcards

1
Q

Which organization approves drugs?

A

The FDA

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2
Q

What subsects of the FDA are involved in drug approval?

A

The Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH)

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3
Q

What is a drug?

A

A substance that exerts an action on the body by chemical action or metabolism and is used in the diagnosis, cure, mitigation, treatment, or prevention of disease

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4
Q

What is a new drug referred to as?

A

Not generally recognized as safe and effective (GRASE)

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5
Q

What is the first stage of new drug development and approval?

A

Drug discovery and development

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6
Q

What does cGMP stand for?

A

Current good manufacturing practices

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7
Q

What does GLP stand for?

A

Good Laboratory Practices

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8
Q

Describe compound-centered drug discovery

A

Producing compounds that will work with biological receptors. Typically mimicked compounds that are endogenous or in nature

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9
Q

What is lead optimization?

A

Find the right match between the target and chemical compound. Maintain the desired properties while reducing any deficiencies. The right match is called a lead compound

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10
Q

What is the second stage of new drug development and approval?

A

Pre-clinical research and development

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11
Q

What happens during preclinical testing?

A

-Pharmacodynamic, pharmacokinetic, and toxicology testing
-therapeutic effects and safety tested in animals
-takes 1-3 years
-No prior approval is needed to begin

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12
Q

What is the 3rd stage of the new drug development and approval process?

A

Clinical trial

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13
Q

What does a company have to submit between the pre-clinical and clinical trial phases?

A

A Investigational New Drug application

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14
Q

What are drugs studied in a clinical trial called?

A

Investigational drugs

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15
Q

Why do clinical trials have phases?

A

To establish the efficacy and safety, to protect the human test subjects, and to ensure the integrity and usefulness of the clinical study data

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16
Q

Before proceeding with a clinical study, what do you have to do?

A

Submit a investigational new drug application and have no objection by FDA and have the IRB approve it

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17
Q

What does the IRB look at before approving a clinical study?

A

The protection of human test studies and informed consent documents

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18
Q

What is the gold standard of clinical trial design?

A

Double blind randomized controlled trial

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19
Q

What sample size should you use?

A

A sample size that is sufficient to reveal a conclusion statistically

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20
Q

What is a superiority design?

A

Shows that a treatment is better than a placebo

21
Q

What is a non inferiority design?

A

You are making sure that the new drug is not worse than the standard

22
Q

What is equivalence design?

A

You are determining whether one intervention is the same in effectiveness as another

23
Q

Describe phase 1 of a clinical trial

A

-healthy volunteers
-establish pharmacokinetic profile, safety, and dosage (in a fast track study, people with the diagnosis are allowed to be included)
-study size is small, and generally the study goes for 1 year or less

24
Q

Describe the phase II of a clinical trial

A

-establish the pharmacokinetic profile, safety, and efficacy with a bigger study size
- uses people with the disease
-2 parts: A and B. A=pilot study. B=single or double blinded control study
-Medium size (100s)
-lasts weeks to months

25
Q

Describe phase 3 of a clinical trial

A

The final stage before drug approval
-PK profile, safety, efficacy, final formulation, indications, labeling, marketing claims, product stability, packaging, storage conditions established
-double blind with a large study size

26
Q

What is submitted after the clinical trial?

A

A new drug application

27
Q

What does the FDA reviewer of the NDA look for

A

Whether the drug is safe and effective and benefits>risks, if the package insert is appropriate, and whether the quality control methods are appropriate

28
Q

What are the 3 options that the FDA reviewer could provide in response to a NDA

A

Approval letter, approvable letter, or nonapprovable letter

29
Q

What is the fast track in regards to the new drug application?

A

-priority and rolling review
-drug fills an unmet medical need or treats a serious disease.

30
Q

What is accelerated approval in regards to the new drug application?

A

-Drugs that fill unmet medical need and treats serious disease
-accelerated through approval process
-after marketing trials have to verify clinical benefits
-Reapply after marketing

31
Q

What is a priority review in regards to the NDA

A

The FDA will review the NDA within 6 months because the drug is important for serious conditions

32
Q

What is a breakthrough therapy designation

A

A expedited process for drugs that treat serious conditions
-based on preliminary clinical evidence that says that it is an improvement on available therapy
-Requested at end of phase 2

33
Q

Explain postmarketing surveillance

A

Not usually required, but sometimes for fast-track.
Double blinded with a huge study size over many years (general population)

34
Q

What is FAERS?

A

The FDAs Adverse Event Reporting System. It is a database for adverse events and medication errors.

35
Q

What is the FDA’s sentinel initiative?

A

A national electronic system to monitor safety of FDA regulated medical products after they reach the market. It complements the adverse event reporting system

36
Q

What is an orphan drug

A

-A drug used to treat rare diseases affecting fewer than 200,000 people in the US
-Orphan Drug Act of 1983 gives grants, tax credits, and 7 year market exclusivity

37
Q

What is an abbreviated new drug application?

A

An application for generic drugs after the patent is up. It requires demonstration of bio equivalence to the innovator drug and must deliver the same amount of active ingredients in the same time.

38
Q

What are the principles of OTC status?

A

safe, easy to use method (usually oral), high benefit to risk ratio, and adequacy of labeling for self-medication

39
Q

What does GRASE stand for?

A

Generally Recognized As Safe and Effective

40
Q

What is a biologic?

A

A substance derived from living organisms

41
Q

Which organization deals with biologics licensure?

A

CBER

42
Q

What is responsible for devices with therapeutic claims?

A

CDRH

43
Q

What are the classes of devices?

A

I, II, III

44
Q

All promotional information must be …

A

Truthful, fairly balanced, and fully disclosed

45
Q

Does the FDA have the jurisdiction to inspect manufacturer’s premises?

A

Yes

46
Q

What can enforcement look like?

A

A warning letter, seizure, or recall

47
Q

What are the 3 classes of recall?

A

Class I: seriously harmful, class II: temporary or medically reversible harm, class III: not likely to cause adverse effects

48
Q

What is an example of a reason a drug would have a class III recall?

A

The drug may not be effective even though it is not dangerous

49
Q

What are some limitations to the drug approval process??

A

The FDA does not review advertisements, postmarketing surveillance may not be adequate, pressure for speedy approvals may result in compromise to safety or efficacy, sometimes there are conflicts of interest, and the FDA does not compare competing drugs or require tests of clinical efficacy for new devices

Pharmacology (4 decks)

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