Drug Development Process

Question 1

Dosage formulations used for clinical evaluation of a new drug

Answer 1

Clinical Drug Materials (CTM)

Question 2

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

Answer 2

Investigational New Drug (IND)

Question 3

Gains permission to market drug product

Answer 3

New Drug Application (NDA)

Question 4

Application by the sponsot of approved NDA to make changes

Answer 4

Supplemental New Drug Application (SNDA)

Question 5

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

Answer 5

Abbreviated New Drug Application (ANDA)

Question 6

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

Answer 6

Biologics License Application (BLA)

Question 7

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

Answer 7

International Conference on Harmonization (ICH)

Question 8

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

Answer 8

Drug substance

Question 9

Production processes of drug substance

Answer 9

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

Question 10

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

Answer 10

New Chemical Entity (NCE)

Question 11

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

Answer 11

Drug product

Question 12

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

Answer 12

Drugs

Question 13

Intended use of drugs

Answer 13

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

Question 14

Sources of drugs

Answer 14

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

Question 15

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

Answer 15

Plant sources

Question 16

Uses of Rauwolfia serpentina

Answer 16

Chemical reserpine, tranquilizer, and as a hypotensive agent

Question 17

Uses of Vinca rosea

Answer 17

Antidiabetic agent and antitumor activity

Question 18

Uses of Vitex negundo

Answer 18

Anti-inflammatory and bronchial smootg muscle relaxant

Question 19

Uses of Magostana garcinia

Answer 19

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

Question 20

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

Answer 20

Animal sources

Question 21

Insulin source

Answer 21

Pancreas

Question 22

Hormone for regulating diabetes

Answer 22

Insulin

Question 23

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

Answer 23

Human chorionic gonadotropin

Question 24

Source of thyroxin used in hypertension

Answer 24

Sheep thyroid

Question 25

Vitamins that are sourced from cod liver

Answer 25

Vitamin A and D

Question 26

Sourced from anterior pituitary and is used for treating infertility

Answer 26

Pituitary gonadotropins

Question 27

Usage of animal blood

Answer 27

Preparation of vaccines

Question 28

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

Answer 28

Pepsin and trypsin

Question 29

Treatment for iron-deficiency anemia

Answer 29

Iron

Question 30

Treatment for iron-deficiency anemia

Answer 30

Iron

Question 31

Mineral used to treat syphillis

Answer 31

Mercurial salts

Question 32

Mineral used in treating wounds and eczema

Answer 32

Zinc oxide paste

Question 33

It is used as an antiseptic

Answer 33

Iodine

Question 34

Used in treating rheumatoid arthritis

Answer 34

Gold salts

Question 35

Minerals that have antiseptic properties

Answer 35

Fluorine and borax

Question 36

Used in anti-dandruff shampoos

Answer 36

Selenium

Question 37

Mineral used in the preparation of liquid paraffin

Answer 37

Petroleum

Question 38

Inclusions in microbiological sources

Answer 38

Serums, antitoxins, and vaccines

Question 39

Person who worked on smallpox vaccine

Answer 39

Edward Genner, 1796

Question 40

Renal monkey vaccine

Answer 40

Poliomyelitis vaccine

Question 41

Chick embryo vaccine

Answer 41

Mumps and influenza vaccine

Question 42

Duck embryo vaccine

Answer 42

Rubella (German measles) vaccine

Question 43

A microbiological source of penicillin

Answer 43

Penicillin notatum fungus

Question 44

Streptomycin microbiological source

Answer 44

Actinobacteria

Question 45

Source of aminoglycosides such as gentamicin and tobramycin

Answer 45

Streptomycis and micromonosporas

Question 46

Synthetic sources

Answer 46

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

Question 47

Example of synthetic source

Answer 47

Emetine Bismuth synthetic

Question 48

Semi synthethic sourcee

Answer 48

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

Question 49

Example of semi synthetic source

Answer 49

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