Pharmacy Practice Exam 3 UPDATED
Exam Questions and CORRECT Answers
Investigational New Drug (IND) - CORRECT ANSWER - Drug/antibiotic/biologic used
in a clinical investigation
Drug is NOT marketed
Label must bear the statement: "Caution: New Drug - Limited by Federal (or United States) law
to investigational use."
Investigational New Drug Application (INDA) - CORRECT ANSWER - Submission to
FDA containing chemical info, preclinical data, and detailed description of planned clinical trials
30 days after the FDA acknowleges receipt of this, clinical trials can be initiated
FDA (Food and Drug Administration) - CORRECT ANSWER - Responsible for ensuring
safety and efficacy of ALL food, drugs, cosmetics, and drug devices on the market
Drug Master File (DMF) - CORRECT ANSWER - References on file with the FDA that
contain information on the drug
CMC - Chemistry, manufacturing, and controls of the drug to be included in the filing of an IND
Institutional Review Board (IRB) - CORRECT ANSWER - Committee of reviewers
evaluating the safety and ethical considerations of a clinical study protocol
Evaluate research protocols and informed consent
To ensure rights and welfare of patients - risks are minimal, informed consent obtained; expected
risk to anticipated benefit ratio should be minimal
Review ongoing research annually and evaluate adverse experiences
Orphan Drug (OD) - CORRECT ANSWER - Used for treatment of rare disease (affecting
<200,000) or revenues do not justify cost of research and development
,Clinical Investigation - CORRECT ANSWER - Any experiment in which a drug is
administered or dispensed to one or more human subjects
Sponsor - CORRECT ANSWER - Organization who takes responsibility for and initiates
the clinical investigation
Clinical Safety Officer - CORRECT ANSWER - This the sponsor's contact person with the
FDA (usually MD)
Contract Research Organization - CORRECT ANSWER - Group that assumes one or more
of the obligations of the sponsor
Drug Importation Act (1848) - CORRECT ANSWER - Prohibited the importation of
unsafe or adulterated drugs at key ports of entry
Biologics Controls Act of 1902 - CORRECT ANSWER - Mandated annual licensing of
establishments to manufacture and sell vaccines, sera, antitoxins, and similar products in
interstate commerce
Pure Food and Drugs Act (1906) - CORRECT ANSWER - Prohibited interstate commerce
of adulterated or misbranded drugs
Required labeling of selected dangerous and addictive substances
Identified United States Pharmacopoeia and the National Formulary as official standards fro
drugs
Food, Drug, and Cosmetic Act (1938) - CORRECT ANSWER - Required that firms prove
evidence of safety to the FDA before marketing
Placed drug advertising under the jurisdiction of the Federal Trade Commission
Durham-Humphrey Amendment (1951) - CORRECT ANSWER - Amended the FD&C
Act of 1938 to statutorily differentiate prescription and nonprescription drugs
, Kefauver-Harris Drug Amendment (1962) - CORRECT ANSWER - Established the
requirement for drug firms to demonstrate efficacy as well as safety
Orphan Drug Act (1983) - CORRECT ANSWER - Established grants, federal assistance
for research, and tax incentives to develop drugs targeted for a patient population of less than
200,000
Drug Approval Process - CORRECT ANSWER - Pre-clinical studies
INDA submission/acceptance
Clinical investigation
NDA submission/acceptance
FDA approval
Drug Marketed
Study Protocol - CORRECT ANSWER - Purpose:
1) Outlines objectives of a clinical research trial
2) Must be approved by IRB
3) Clear and attainable scientific goals
Parts:
1) Title page
2) Table of contents
3) Introduction and scientific background
4) Objectives
5) Patient eligibility criteria
6) Procedure
Also: tx plan, criteria for response assessment, procedure in event of response, no response, or
toxicity; dose modification, statistics, references, records to be kept, copy of informed consent
Exam Questions and CORRECT Answers
Investigational New Drug (IND) - CORRECT ANSWER - Drug/antibiotic/biologic used
in a clinical investigation
Drug is NOT marketed
Label must bear the statement: "Caution: New Drug - Limited by Federal (or United States) law
to investigational use."
Investigational New Drug Application (INDA) - CORRECT ANSWER - Submission to
FDA containing chemical info, preclinical data, and detailed description of planned clinical trials
30 days after the FDA acknowleges receipt of this, clinical trials can be initiated
FDA (Food and Drug Administration) - CORRECT ANSWER - Responsible for ensuring
safety and efficacy of ALL food, drugs, cosmetics, and drug devices on the market
Drug Master File (DMF) - CORRECT ANSWER - References on file with the FDA that
contain information on the drug
CMC - Chemistry, manufacturing, and controls of the drug to be included in the filing of an IND
Institutional Review Board (IRB) - CORRECT ANSWER - Committee of reviewers
evaluating the safety and ethical considerations of a clinical study protocol
Evaluate research protocols and informed consent
To ensure rights and welfare of patients - risks are minimal, informed consent obtained; expected
risk to anticipated benefit ratio should be minimal
Review ongoing research annually and evaluate adverse experiences
Orphan Drug (OD) - CORRECT ANSWER - Used for treatment of rare disease (affecting
<200,000) or revenues do not justify cost of research and development
,Clinical Investigation - CORRECT ANSWER - Any experiment in which a drug is
administered or dispensed to one or more human subjects
Sponsor - CORRECT ANSWER - Organization who takes responsibility for and initiates
the clinical investigation
Clinical Safety Officer - CORRECT ANSWER - This the sponsor's contact person with the
FDA (usually MD)
Contract Research Organization - CORRECT ANSWER - Group that assumes one or more
of the obligations of the sponsor
Drug Importation Act (1848) - CORRECT ANSWER - Prohibited the importation of
unsafe or adulterated drugs at key ports of entry
Biologics Controls Act of 1902 - CORRECT ANSWER - Mandated annual licensing of
establishments to manufacture and sell vaccines, sera, antitoxins, and similar products in
interstate commerce
Pure Food and Drugs Act (1906) - CORRECT ANSWER - Prohibited interstate commerce
of adulterated or misbranded drugs
Required labeling of selected dangerous and addictive substances
Identified United States Pharmacopoeia and the National Formulary as official standards fro
drugs
Food, Drug, and Cosmetic Act (1938) - CORRECT ANSWER - Required that firms prove
evidence of safety to the FDA before marketing
Placed drug advertising under the jurisdiction of the Federal Trade Commission
Durham-Humphrey Amendment (1951) - CORRECT ANSWER - Amended the FD&C
Act of 1938 to statutorily differentiate prescription and nonprescription drugs
, Kefauver-Harris Drug Amendment (1962) - CORRECT ANSWER - Established the
requirement for drug firms to demonstrate efficacy as well as safety
Orphan Drug Act (1983) - CORRECT ANSWER - Established grants, federal assistance
for research, and tax incentives to develop drugs targeted for a patient population of less than
200,000
Drug Approval Process - CORRECT ANSWER - Pre-clinical studies
INDA submission/acceptance
Clinical investigation
NDA submission/acceptance
FDA approval
Drug Marketed
Study Protocol - CORRECT ANSWER - Purpose:
1) Outlines objectives of a clinical research trial
2) Must be approved by IRB
3) Clear and attainable scientific goals
Parts:
1) Title page
2) Table of contents
3) Introduction and scientific background
4) Objectives
5) Patient eligibility criteria
6) Procedure
Also: tx plan, criteria for response assessment, procedure in event of response, no response, or
toxicity; dose modification, statistics, references, records to be kept, copy of informed consent
