drug development process terminologies

Question 1

Dosage formulations used for clinical evaluation of a new
drug

Answer 1

Clinical Drug Materials (CTM)

Question 2

• Protects the right & safety of the subjects
• ensures investigational plan is sound & designed to
  achieve the stated objectives

Answer 2

Investigational New Drug (IND)

Question 3

• Gains permission to market the drug product

Answer 3

New Drug Application (NDA)

Question 4

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

Answer 4

Abbreviated New Drug Application (ANDA)

Question 5

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

Answer 5

Biologics License Application (BLA)

Question 6

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

Answer 6

International Conference on Harmonization (ICH)

Question 7

active ingredient/component that produces
pharmacologic activity

Answer 7

DRUGS SUBSTANCE

Question 8

drug substance with unknown clinical, toxicologic, physical & chem.
properties

Answer 8

NEW CHEMICAL ENTITY (NCE)

Question 9

finished dosage form (containing the drug subs. + other
excipients/inert substances)

Answer 9

DRUG PRODUCT

Question 10

Drugs refer to pharmaceutical products that pertain to
chemical compounds or biological substances, other
than food, intended for use in the treatment,
prevention, or diagnosis of disease in humans or
animals,

Answer 10

DRUGS