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Farm > Intro > Flashcards

Intro Flashcards

1
Q

What is the main goal of in vitro studies of drug development?

A

Discovering a “lead compound” from biological and/or chemical products. (takes an average of 2 years)

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2
Q

What are the three factors typically tested during animal testing?

A

1) Efficacy 2) Selectivity 3) Mechanism

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3
Q

Which phases take place during “Clinical Testing” and what question does each hope to answer?

A

Phase 1- “Is it safe?”… pharmacokinetics
Phase 2- “Does it work in patients?”
Phase 3- “Does it work with genetic variations, double blind?”

Takes an average 4 years.

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4
Q

When is a drug considered an IND and what does that stand for?

A

Investigational New Drug- after approved animal testing and at the start of clinical testing; usually when the drug is patented

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5
Q

What is happening during phase 4?

A

Postmarketing surveillance

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6
Q

What type of research is considered the “Valley of Death” when it comes to development funding?

A

Translational Research: a mix of government & private funding

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7
Q

Pure Food and Drug Act (1906)

A

After release of “The Jungle”: Insures purity and proper labeling

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8
Q

Federal Food, Drug and Cosmetic Act (1938)

A

Requires toxicity studies for safety; enforced by FDA

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9
Q

Kefauver-Harris Amendments (1962)

A

Requires proof of efficacy, established guidelines for reporting adverse effects, clinical testing & advertising, and established FDA authority over manufacturing

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10
Q

FDA Modernization Act (1997)

A
  • Expedited reviews for drugs for serious diseases; permits marketing even before Phase 2 and 3 studies completed
  • Exp. AIDS drug, Indinivar, approved in 42 days! WOWZA
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11
Q

What is the difference between a dietary supplement and a drug?

A

Dietary supplements do not go through the same extensive evaluations. They can’t say that they are good for any particular disease state.

CAN NOT PATENT HERBALS IN THE US (not profitable)

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12
Q

How does FDA regulate herbals, supplements, minerals, and vitamins?

A

Only regulates sanitary production conditions and good laboratory practices. There is no requirement to prove efficacy or safety!!!!!! (yikes.)

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13
Q

Dietary Supplement and Non-Rx Drug Consumer Protection Act (2006)

A

Requires manufacturer to report serious adverse events

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14
Q

Indications for St John’s Wort (Hypericum Perforatum)

A

Mild/moderate depression

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15
Q

Pharmacology SJW

A

Perennial weed containing hyperforin and hypericin

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16
Q

Toxicities/Side effects SJW

A

Photosensitivity(?); GI complaints

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17
Q

Potential interactions SJW

A
  • Reduced efficacy of some drugs- including ORAL CONTRACEPTIVES
  • Induces CYP3A4, CYP2C9 (drug metabolizing enzymes) and P-gp (can pump drugs out of cells)
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18
Q

Indications for Echinacea

A

Common cold and flu (some evidence of decreasing symptoms/duration of URI)

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19
Q

Pharmacology: Echinacea

A

Contains polysaccharides, chicoric acid, alkamides…

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20
Q

Toxicity/Side Effects: Echinacea

A

Minimal: GI upset and headache

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21
Q

Contraindications: Echinacea

A
  • NOT for CHILDREN
  • Shouldn’t be taken for longer than 10 days
  • Should be avoided in patients taking immunosuppressants, or with immunodeficiency, or autoimmune diseases
22
Q

Indications: Ginkgo (Ginkgo biloba) (the worst smelling trees in the world)

A
  • Cardiovascular Disease (UNPROVEN)

- Preventative for cognitive impairment or dementia (UNPROVEN)

23
Q

Pharmacology: Ginkgo

A
  • Flavone glycosides; terpenoids

- Antioxidants; antagonize platelet activating factor; increase NO release

24
Q

Toxicity/Side effects: Ginkgo

A

Headache, GI upset, “some bleeding”

25
Q

Contraindications: Ginkgo

A

Antiplatelet or anticoagulant drugs

…Epileptics

26
Q

Indications: Ginseng (Panax ginseng)

A

Only SOME evidence…

  • Preventing colds
  • Preventing cancer…
  • Reducing postprandial blood glucose levels
27
Q

Pharmacology: Ginseng

A
  • Contains triterpenoids (ginsenosides) and methylzanthines (caffeine-like effect)
  • Stimulates immune system
  • Antiplatelet activity
28
Q

Contraindications: Ginseng

A

Antipsychotics, estrogens, hypoglycemics, or anticoagulants

29
Q

Indications: Garlic (Allium sativum)

A

May reduce incidence of some cancers

Not proven to reduce LDL

30
Q

Pharmacology: Garlic

A

Contains organosulfur compounds including allicin

  • Antiplatelet
  • Fibrinolytic (clot breakdown)
  • Antioxidant
31
Q

Contraindications: Garlic (Allium sativum)

A

Anticoagulants

32
Q

Milk Thistle (Silybum marianum): Indications

A

No clear evidence

  • prevention of hepatotoxicities
  • some anti-inflammatory activities are reported
    • reduced leukotriene formation
    • reduced leukocyte migration
33
Q

Milk Thistle: Toxicity/Side effects

A

Few!

34
Q

Milk Thistle: Drug interactions

A

Few!

35
Q

What are “phytoestrogens?”

A

Non-steroidal ligands for estrogen receptors.

They help w/ persistent vasomotor effects (hot flashes) post menopause.

36
Q

What are two examples of phytoestrogens?

A

1) Red clover (Trifolium pratense)

2) Soy bean (Glycine max)

37
Q

Saw Palmetto (Serenoa repens): Indications

A

No clear evidence

Improves symptoms of benign prostatic hypertrophy

38
Q

Saw Palmetto: Pharmacology

A

Constituent phytosterols inhibit 5-alpha reductase in vitro.

39
Q

Saw Palmetto: Toxicity/Side effects

A

Low incidence…so…?

40
Q

Saw Palmetto: Drug interactions

A

None reported

41
Q

High doses of certain vitamins can be beneficial; an example being _ in which 10x the MDR may act as __

A

Vitamin C; immunostimulant, antioxidant (decrease duration of colds)

42
Q

High doses of other vitamins can be DANGEROUS; an example being __; the MDR is __ and it is safe up to __

A

Vitamin E; 30 international units (IU)/day; 130 IU/day

The claim of cardioprotection with 800 IU/day is FALSE

43
Q

Coenzyme Q 10 (Ubiquinone): Indication

A
  • Mitochondrial diseases (exp. familial defect in Q 10 synthesis –> leigh’s encephalomyopathy = ataxia and decreased growth)
  • Some benefit in ischemic heart disease (may decrease the anticoagulant effect of warfarin)
44
Q

CoQ 10: Pharmacology/mechanism of action

A

Electron carrier in mitochondria of all tissues; highest in heart; decreases with age

45
Q

Melatonin: Indications

A

Sleep aid; jet lag

46
Q

Melatonin: Pharmacology

A

Principal indoleamine in pineal gland; synthesis is usually controlled by light; lipid soluble (?)

47
Q

What is the Rx version of melatonin?

A

Ramelteon (melatonin analog)

48
Q

Melatonin: Toxicity/Side effects

A

Drowsiness and ataxia

49
Q

Melatonin: Drug interactions

A
  • Synergistic with alcohol
  • Metabolized by CYP 1A2
  • May interfere with warfarin action
50
Q

Dietary supplements for osteoarthritis

A

Mixed results for improving function and reducing pain

  • Glucosamine- substrate for production of articular cartilage
  • Chondroitin sulfate- proteoglycan may modify extracellular matrix to stabilize articular cartilage
51
Q

Contraindications/Drug interactions for osteoarthritis dietary supplements

A

May increase bleeding in patients taking warfarin

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