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PH 107 > Drug Development Process > Flashcards

Drug Development Process Flashcards

1
Q

Dosage formulations used for clinical evaluation of a new drug

A

Clinical Drug Materials (CTM)

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2
Q

Protects the right and safety of the subjects and ensure investigational plan is sound and designed to achieve the stated objectives

A

Investigational New Drug (IND)

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3
Q

Gains permission to market drug product

A

New Drug Application (NDA)

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4
Q

Application by the sponsot of approved NDA to make changes

A

Supplemental New Drug Application (SNDA)

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5
Q

Nonclinical laboratory studies and clinical investigations may be omitted, except those pertaining to the drug’s bioavailability

A

Abbreviated New Drug Application (ANDA)

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6
Q

Manufacture of biologicals (blood products, vaccines, and toxins)

A

Biologics License Application (BLA)

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7
Q

It brings together regulatory requirements and establishes (long range goal) a uniform set of standards for drug registration within geographic areas

A

International Conference on Harmonization (ICH)

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8
Q

Active ingredient or component that produces pharmacologic activity and the purification needrd before use in a drug product

A

Drug substance

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9
Q

Production processes of drug substance

A

Chemical synthesis, enzymatic reaction, recovery from a natural product, recombinant DNA technology, and the combination of said processes

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10
Q

Drug substance with unknown clinical, toxicologic, physical and chemical properties

A

New Chemical Entity (NCE)

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11
Q

Finished dosage form containing drug substance plus other excipients or inert substances

A

Drug product

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12
Q

Pharmaceutical products that pertain to chemical compounds or biological substances, other than food.

A

Drugs

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13
Q

Intended use of drugs

A

Treatment, prevention, cure, or diagnosis of disease in humans or animals

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14
Q

Sources of drugs

A

Plant, animal, mineral, microbiological, synthetic and semi-synthetic, genetic engineering sources

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15
Q

Source for the conversion of botanic folklore remedies into modern wonder drugs

A

Plant sources

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16
Q

Uses of Rauwolfia serpentina

A

Chemical reserpine, tranquilizer, and as a hypotensive agent

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17
Q

Uses of Vinca rosea

A

Antidiabetic agent and antitumor activity

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18
Q

Uses of Vitex negundo

A

Anti-inflammatory and bronchial smootg muscle relaxant

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19
Q

Uses of Magostana garcinia

A

Treatment for skin infections, wounds, dysentery, and urinary tract infections

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20
Q

Provided drugs that are mannered from their tissues or through their biologic processes

A

Animal sources

21
Q

Insulin source

22
Q

Hormone for regulating diabetes

23
Q

It is from the urine of pregnant women and is used for treating infertility

A

Human chorionic gonadotropin

24
Q

Source of thyroxin used in hypertension

A

Sheep thyroid

25
Q

Vitamins that are sourced from cod liver

A

Vitamin A and D

26
Q

Sourced from anterior pituitary and is used for treating infertility

A

Pituitary gonadotropins

27
Q

Usage of animal blood

A

Preparation of vaccines

28
Q

Digestive juices from stomach tissues used for treating peptic diseases in the past

A

Pepsin and trypsin

29
Q

Treatment for iron-deficiency anemia

30
Q

Treatment for iron-deficiency anemia

31
Q

Mineral used to treat syphillis

A

Mercurial salts

32
Q

Mineral used in treating wounds and eczema

A

Zinc oxide paste

33
Q

It is used as an antiseptic

34
Q

Used in treating rheumatoid arthritis

A

Gold salts

35
Q

Minerals that have antiseptic properties

A

Fluorine and borax

36
Q

Used in anti-dandruff shampoos

37
Q

Mineral used in the preparation of liquid paraffin

38
Q

Inclusions in microbiological sources

A

Serums, antitoxins, and vaccines

39
Q

Person who worked on smallpox vaccine

A

Edward Genner, 1796

40
Q

Renal monkey vaccine

A

Poliomyelitis vaccine

41
Q

Chick embryo vaccine

A

Mumps and influenza vaccine

42
Q

Duck embryo vaccine

A

Rubella (German measles) vaccine

43
Q

A microbiological source of penicillin

A

Penicillin notatum fungus

44
Q

Streptomycin microbiological source

A

Actinobacteria

45
Q

Source of aminoglycosides such as gentamicin and tobramycin

A

Streptomycis and micromonosporas

46
Q

Synthetic sources

A

When the nucleus of drug is obtained from natural source as well as its chemical structure is altered

47
Q

Example of synthetic source

A

Emetine Bismuth synthetic

48
Q

Semi synthethic sourcee

A

When the nucleus of the drug obtained from natural source is retained but the chemical structure is altered

49
Q

Example of semi synthetic source

A

Apormorphine, diacetyl morphine, ethinyl estradiol, homatropine, ampicillin, and methyl testosterone.

PH 107 (2 decks)

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