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Pharmacology -- Test #1 > Drug Development and Herbals > Flashcards

Drug Development and Herbals Flashcards

1
Q

What is a biologic? Most common example of a biologic?

A

Substance used to replace something that is naturally already there
Insulin

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2
Q

Two major components of pre-clinical testing.

What do you call a substance that makes it through

A

In vitro studies and animal testing

Investigational New Drug

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3
Q

What are you trying to determine in Phase 1 clinical testing? How many subjects?

A

Is it safe? Pharmacokinetics?

20-100 Subjects

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4
Q

What are you trying to determine in Phase 2 clinical testing? How many subjects?

A

Does it work in patients?

100-200 patients

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5
Q

What are you trying to determine in Phase 3 clinical testing? How many subjects?

A

Does it work? Double blind

1,000-6,000

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6
Q

If the clinical testing phase is successfully completed, what happens next?

A

New Drug Application

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7
Q

A successful drug takes about __ years to get tom concept to marketing.

A

15

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8
Q

Discoverers of cholesterol synthesis?

A

Brown and Goldstein

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9
Q

Significance of the Pure Food and Drug Act (1906)

A

Insures purity and proper labeling

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10
Q

Significance of Federal Food, Drug, and Cosmetic Act (1938)

A

Required FDA toxicity studies

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11
Q

Significance of the Kefauver-Harris Amendments (1962)

A

Required proof of efficacy
established guidelines for reporting adverse effects, clinical testing, and advertising
FDA authority over maufacturing

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12
Q

Significance of the FDA modernization Act (1997)

A

Expedited review for drugs for serious diseases

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13
Q

Indication for taking St. John’s Wort

A

Mild/Moderate Depression

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14
Q

Active Ingredients of St. Join’s Wort?

A

Hyperforin, Hypericin

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15
Q

Potential drug interactions of St. John’s Wort?

A

It induces CYP 3A4, 2C9, and P-gp

This can speed up breakdown of other drugs (like contraceptives)

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16
Q

Potential side effect(s) of St. John’s Wort?

A

Photosensitivity

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17
Q

Indication for Echinacea?

A

Immunostimulant for common cold and flu

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18
Q

Active components of echinacea?

A

Polysaccharides, Chicoric Acid, Alkamides

19
Q

Side Effects of echinacea?

A

Minimal

GI upset, Headache

20
Q

Who shouldn’t take echinacea?

A

Patients taking immuno-suppressants

Patients with auto-immune disease

21
Q

Indications for Ginkgo?

A

Proven – Peripheral Vascular Disease

Unproven – Prevent cognitive Impairment or dementia

22
Q

Adverse effects of Ginkgo?

A

Headache, GI Upset, Some Bleeding

23
Q

Active components of Ginkgo?

A

Flavone glycosides, terpenoids

24
Q

Who shouldn’t use Ginkgo?

A

People on anti-platelet drugs or anti-coagulant

Epileptics

25
Q

Indications for Ginseng?

A

Some evidence for preventing colds, cancer, and reducing postprandial blood glucose levels

26
Q

Actions of Ginseng?

A

Stimulates Immune System

Antiplatlet Activity

27
Q

Active components of Ginseng?

A

Contains triterpenoids, methylxanthines

28
Q

Who shouldn’t use Ginseng?

A

Antipsychotics, Estrogens, hypoglycemics, or anticoagulants

29
Q

Indications for Garlic?

A

May reduce incidence of some cancers

30
Q

Actions of Garlic?

A

Antiplatelet
Fibrinolytic
Antioxidant

31
Q

Active components of Garlic?

A

Organosulfur compounds including allicin

32
Q

How shouldn’t use Garlic?

A

People on anti-coagulants

33
Q

Actions of Milk Thistle?

A

Some anti-inflammatory activities reported (reduced leukotriene formation, leukocyte migration)

Sometimes used for alcoholic liver cirrhosis

34
Q

Two plants recommended for relief of post-menopausal symptoms. Active component?

A

Red Clover, Soy Bean

Phytoestrogens

35
Q

Actions of saw palmetto

A

Phytosterols inhibit 5alpha reductase in vitro

Given for possible improvement of benign prostatic hypertrophy symptoms

36
Q

Four groups who are not recommended to take herbals

A

Pregnant Women
Lactating Mothers
Infants
Young Children

37
Q

Example of a vitamin with a positive effect of a high dose.

A

High doses of vitamin C decrease cold duration

38
Q

Example of a vitamin with a negative effect of high doses

A

Vitamin E led to increase death

39
Q

What is Coenzyme Q10 (Ubiquinone)?

A

Electron carrier in mitochondria

40
Q

What do you treat with Ubiquinone?

A

Mitochondrial Diseases (Leigh’s encephalomyopathy – familial defect in Q10 synthesis)

Also some benefit in ischemic heart disease

41
Q

Effects of melatonin?

A

Drowsiness and Ataxia, synergistic with alcohol

42
Q

Drug interactions of melatonin?

A

Broken down by Cyp1A2, so it may interfere with Warfarin action

43
Q

Supplements considered for treatment of osteoarthritis?

A

Glucosamine and Chondroitin sulfate

Pharmacology -- Test #1 (8 decks)

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