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Pharmacy > Drug Discovery > Flashcards

Drug Discovery Flashcards

1
Q

FDA

A

Food and Drug Administration

The 1938 Federal Food, Drug, and Cosmetic Act gives the FDA its current authority to regulate medications. Signed by FDR

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2
Q

Drug

A

All drugs are chemicals. Most drugs either enhance or diminish an existing physiologic function of an organism.

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3
Q

Pharmacognosy

A

The study and discovery of drug substances from natural sources

Example: caffeine, morphine, cocaine

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4
Q

Pharmacokinetics

A

The branch of pharmacology concerned with the movement of drugs within the body

ADME

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5
Q

Lead Compound

A

The initial step in the drug approval process is identification of a chemical compound from a larger group of compounds which is most likely to be an effective and safe drug

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6
Q

Preclinical Testing

A

Before the lead compound can be administered to humans, it must go through a series of in-vitro and animal tests

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7
Q

ADME

A

Absorption
Distribution
Metabolism
Excretion

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8
Q

IND

A

Investigational New Drug

If IND status is granted, the investigational drug is cleared to begin human testing

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9
Q

Clinical Trial

A

Drug studies performed in human subjects

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10
Q

Biomarker

A

Something that is measured as an indicator of health, disease, or response to a therapeutic intervention. They may be used to monitor the effects of a medication to determine if it has an effect or not

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11
Q

Endpoint

A

A clinical trial’s “endpoints” are measurements of what happens to people in the trial

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12
Q

NDA

A

New Drug Application

How drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US

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13
Q

Supplemental NDA

A

A supplemental new drug application based on an existing new drug application filed and approved by the FDA with respect to the existing product

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14
Q

How much does it cost for the drug approval process?

A

Around $800 million, going from lead compound to FDA approval

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15
Q

Clinical Trial Phase I

A

Safety
Is the investigational medication/treatment safe?
- Are there side effects?
- How does it affect or move through the body?
- Is it safe to use at the same time as other medications?

Group size: generally less than 100 healthy people

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16
Q

Clinical Trial Phase II

A

Efficacy
Is the investigational medication/treatment effective in treating the targeted condition?
- Does it relieve, reverse, or stop the progression of the condition?
- How safe is it?
- What is the most effective dosage?

Group size: generally 100-300 people with the condition being studied

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17
Q

Clinical Trial Phase IV

A

Follow Up
After the investigational medication/treatment is approved, how does it work for other patients with the condition?
- More safety/efficacy information is gathered
- Are there long-term benefits?
- Are there long-term risks?

Group size: often several thousand people who have been prescribed the investigational medication

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18
Q

Clinical Trial Phase III

A

Confirmation
How does the investigational medication/treatment compare to the standard treatment for the condition?
- More effective, less effective, or the same?
- Longer-term adverse effects?
- How does it affect quality of life or survival?
- How might it be used along with existing treatment?

Group size: 300-3,000 people with the condition being studied

19
Q

Small Molecule Drug

A

MW of about 1000 or less

Most currently marketed drugs are small molecule

20
Q

Large Molecule Drug

A

MW weight in the thousands, recombinant DNA technology

21
Q

How long is the drug approval process?

A

10-15 years, going from lead compound to FDA approved drug

22
Q

Drug Classification

A

Most drugs can be placed into large groups based on their pharmacologic action or clinical use. Within these larger groups, drugs are typically placed into classes based on common characteristics. Often, drugs are placed into classes based on their target in the body

23
Q

Sources of New Drugs

A
  • Natural
  • Random Screenings
  • Rational Screenings
24
Q

Endogenous Protein

A

Another natural source of new drugs are the many different proteins that our bodies produce

Example: insulin

AKA: protein drugs, biopharmaceuticals, biological drug

25
Q

Combinatorial Chemistry

A

This technique uses chemical building blocks to form a diverse set of compounds. Drug companies use this to create vast libraries of compounds to screen against a disease

Mix and split method

26
Q

Rational Drug Design

A

Using knowledge of the disease state to design a drug specific to the disease. One approach is the creation of a 3D computer model of a drug target followed by using a computer program to virtually test drug molecules and identify drugs that are likely to bind with the target (molecular modeling)

27
Q

Drug Metabolism

A

An endogenous process in which a drug is converted, usually by an enzyme, to a different molecule called a drug metabolite. In general, drug metabolism is the process our bodies use to help remove drug activity from the body

28
Q

Active Enantiomer

A

The active enantiomer of the original drug may be isolated and marketed as a new drug. An example of this practice is the marketing of the antidepressant Lexapro, which is the S-enantiomer of Celexa

29
Q

1906 Food and Drug Act

A

The act was limited to regulation of interstate transport of adulterated or misbranded products. Does not cover false therapeutic claims

30
Q

Who controls drug strength, quality, and purity?

A

USP (United States Pharmacopeia) or NF (National Formulary)

31
Q

Brand Name

A

AKA Trade Name
As a general rule, the manufacturer which supports the process of bringing a drug to market has the ownership of the drug

32
Q

Generic Name

A

After a period of time during which the brand name drug is marketed, other manufacturers are allowed to develop and bring to market identical versions of the brand name drug

33
Q

Pharmacogenomics

A

AKA Pharmacogenetics
The study of why there is a significant difference in the response of patients to a certain drug due to genetic differences

34
Q

Surrogate Markers

A

Biomarkers accepted by the FDA for drug clinical trials; have already undergone testing in other trials and have proven to be reliable clinical markers

35
Q

Over the Counter Drugs

A

OTC

Drugs that are available to consumers without a prescription

36
Q

Drug (Stedmans)

A

Therapeutic agent; any substance, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease

37
Q

Drug (Pandits)

A

A drug can be defined as a chemical substance that interacts with a part of the body to alter an existing physiological or biochemical process. A drug can increase or decrease an existing function of an organ, tissue, or cell, but cannot impart a new function to them

38
Q

Drug (Rang & Dales)

A

A chemical substance of known structure, other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect

39
Q

Natural Drug

A

A drug discovered in nature that is good enough to market as a pharmaceutical without any chemical modifications

Example: penicillin

40
Q

Semi-synthetic Drug

A

A drug partially synthesized in nature and partially synthesized by man

41
Q

Synthetic Drug

A

A drug that is completely synthesized in a lab

42
Q

ANDA

A

Abbreviated New Drug Application

Submitted to the FDA for the review and potential approval of a generic drug product

43
Q

Racemic Mixture

A

Most drugs are marketed as both the R and S enantiomers

44
Q

Surrogate Endpoint

A

Surrogate endpoints are used when the clinical outcomes might take a very long time to study, or in cases where the clinical benefit of improving the surrogate endpoint, such as controlling blood pressure, is well understood

Pharmacy (2 decks)

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