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Pharmacology > Exam 2: Drug Discovery and the Approval Process > Flashcards

Exam 2: Drug Discovery and the Approval Process Flashcards

1
Q

What is the pharmacognosy or “Eco-mining” approach to how new chemical entities are made?

A

Looks at medicinal drugs obtained from plants or other natural sources

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2
Q

What is the incrementally modified drug approach to how new chemical entities are made?

A

Chemical alteration of a known molecule to change its activity

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3
Q

What is the molecular modeling approach to how new chemical entities are made?

A

Scientists make a stereotypic 3D image of the receptor and the custom build a molecule to react with that receptor

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4
Q

How long is the preclinical phase of human drug development NME?

A

4.3 years

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5
Q

How long are clinical trials and FDA approval in human drug development NME?

A

7.5 years

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6
Q

What is the total amount of time for human drug development NME?

A

11.8 years

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7
Q

What is the total cost of human drug development in the preclinical phase NME?

A

335 million dollars

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8
Q

What is the total cost of human drug development in the clinical trials and FDA approval phase NME?

A

467 million dollars

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9
Q

What is the total cost of human drug development in NME?

A

802 million dollars

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10
Q

What is the cost of veterinary drug development?

A

Estimates vary, but range from $1.5 to $50 million

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11
Q

What is the time for veterinary drug development?

A

8-15 years

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12
Q

Why are there lower costs on veterinary drugs?

A

The product may be a currently approved human drug that is being extended for use in animals, so the development costs have already been covered

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13
Q

How long does a patent last on a drug?

A

A patent normally lasts for 20 years, but it may begin at any time before, during, or after approval by FDA

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14
Q

What is exclusivity?

A

Attaches upon approval of a drug product if the statutory requirements are met
Prevents a generic drug from being approved in specific instances

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15
Q

What are examples of when exclusivity may be granted?

A

Human orphan drug exclusivity- 7 years
New chemical entity exclusivity- 5 years
Generating antibiotic incentives now (GAIN) exclusivity- 5 years added
New clinical investigation exclusivity-3 years
Human pediatric exclusivity
Patent challenge- 180 days for first generic product

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16
Q

How is a withdrawal time determined for a drug that is to be used in a food animal with NOEL?

A

Genetic toxicity studies
90-day feeding studies in rodents and other mammals
Teratology study in rats
Antimicrobial resistance studies
Chronic toxicity and/or carcinogenicity studies in rodents

17
Q

How is a withdrawal time determined for a drug that is to be used in a food animal with Allowable Daily Intake (ADI)?

A

ADI = NOEL/Safety factor

18
Q

How is a withdrawal time determined for a drug that is to be used in a food animal with safety factors?

A

Variability between humans = 10X
Interspecies extrapolation = 10-100X
Subchronic (intermittent exposure) extrapolation = 10X
Total possible = 10-10,000X

19
Q

How is a withdrawal time determined for a drug that is to be used in a food animal with tolerance?

A

Safe concentration = ADI x 60 kg/ consumption factor
Hot and cold studies look at parent and metabolites
Look at target tissue (the edible tissue from which residues deplete most
slowly)- usually liver or kidney.

20
Q

How is a withdrawal time determined for a drug that is to be used in a food animal with marker residue?

A

Monitors depletion of total residues in a tissue

Can be either the parent drug or a metabolite

21
Q

What activities typically occur during the preclinical stage of drug development?

A 
Synthesis and purification
Develop stability and analytical techniques including assay in fluids and tissues
Marketing review
Scale-up
Early pharmacokinetics stiudies
Proof of safety
Proof of efficacy
Management decides "go or no-go"
22
Q

What is scale-up?

A

Create a pilot plant to produce a few hundred grams for testing

23
Q

What happens during proof of safety?

A 
Lab animal acute toxicity studies
Range finding (LD50, LD1)
Genetic toxicity testing
---Treat all products as carcinogens until proven otherwise
Eye irritation studies if a cosmetic
24
Q

What happens during proof of efficacy?

A

In-vitro models

In-vivo disease models

25
Q

What is an INAD?

A

Investigational New Animal Drug Application
Allows legal Interstate shipment of nonapproved drugs
FDA does not “approve” INAD
Applies to new formulation

26
Q

What is a NADA?

A

New animal drug application
Approval by the FDA
Includes ID of sponsor and drug, labeling, manufacturing methods,
samples, safety and efficacy evidence, etc.
Most submission are now performed electronically

27
Q

What is an ANADA?

A

Abbreviate New Animal Drug Application

Approved generic drugs- copy an already approved new animal drug

28
Q

What multiples of dose are typically studied in a target animal margin of safety study?

A

1x, 3x, and 5x dose

29
Q

What is meant by the term “pioneer” drug product?

A

The pioneer drug product is the approved brand name animal drug

30
Q

What is the intent of a phase 1 clinical trial?

A

1°: kinetics and set dose
2°: safety
3°: efficacy

31
Q

What is the intent of a phase 2 clinical trial?

A

1°: efficacy
2°: safety
3°: kinetics

32
Q

What is the intent of a phase 3 clinical trial?

A

Verify effectiveness

Monitor adverse reactions from long-term use

33
Q

What is the intent of Phase 4 testing and/or post-marketing surveillance?

A

Required for some drugs to look for long-term side-effects or public health consequences

34
Q

What is a positive control versus a negative control as it relates to a drug clinical trial?

A

Positive control is the test drug and is usually used

Negative control is the placebo and is used if the disease is mild

35
Q

Compare and contrast a single-masked to a double-masked study.

A

Single masked: Patient doesn’t know treatment, clinician does
Double masked: Neither patient nor clinician know the treatment identity

36
Q

What must happen for any drug that is marketed?

A

Each formulation by each company must be individually approved, including the pioneer and each version of all generic products

Pharmacology (17 decks)

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