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PHA6123 LEC Pharmacy Informatics > Investigational New Drug > Flashcards

Investigational New Drug Flashcards

1
Q

federal agency that decides which drugs, biologics, and medical devices are safe and efficacious

A

FDA

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2
Q

PI

A

primary/principal investigator

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3
Q

IND

A

investigational new drug

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4
Q

QCT

A

qualifying clinical trial

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5
Q

DMF

A

drug master file

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6
Q

CBER

A

center for biologics evaluation and research

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7
Q

CDER

A

center for drug evaluation and research

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8
Q

NDA

A

new drug application

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9
Q

NME

A

new molecular entity

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10
Q

GCP

A

good clinical practice

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11
Q

IRB/IEC

A

institutional review board/institutional ethics committee

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12
Q

CFR

A

code of federal regulations

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13
Q

any experiment in which a DRUG IS ADMINISTERED OR DISPENSED to one or more human subjects

A

clinical investigation

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14
Q

a drug, antibiotic, or biologic that is used in a clinical investigation

A

investigational new drug

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15
Q
A

TRUE

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16
Q

a submission to the FDA containing chemical information, preclinical data, and a detailed description of the planned clinical trials

A

IND application

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17
Q

IND for which the SPONSOR is usually either a CORPORATE ENTITY or one of the institutes of the National Institutes of Health (NIH)

A

commercial IND

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18
Q

responsible for INITIATING the clinical trial at the study site

A

investigator

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19
Q

The investigator must:

A
  1. treat patients
  2. assure that protocol is followed
  3. evaluate responses and adverse rxns
  4. assure proper conduct of the study
  5. solve problems as they arise
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20
Q

PARTICIPATES in a clinical investigation (either as the recipient of the investigational drug or as a member of the control group)

A

subject

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21
Q

STANDARD for the design, conduct, monitoring, analyses, and reporting of clinical trials that provides assurance that the results are credible and accurate, and that the RIGHTS OF STUDY SUBJECTS ARE PROTECTED

A

good clinical practice (GCP)

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22
Q

COMMITTEE OF REVIEWERS that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation

A

Institutional Review Board (IRB)/Institutional Ethics Committee (IEC)

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23
Q
A

FALSE: There was a time when drug products were not regulated.

24
Q

provided for the INSPECTION, DETENTION, and DESTRUCTION
or REEXPORT of imported drug shipments that failed to meet standards

A

Import Drug Act of 1848

25
Q

drugs not to be mislabeled or adulterated and must meet recognized standards for STRENGTH and PURITY

A

Pure Food and Drugs Act (1906)

26
Q

SAFETY OF DRUGS, and be proven through testing before they can be marketed

A

Food, Drug and Cosmetic Act of 1938

27
Q

described submission of NDA to FDA

A

FDCA (1938)

28
Q

creation of OTC and Rx drugs

A

Durham-and-Humphrey Amendment

29
Q

manufacturer had to demonstrate efficacy, and safety of drug prior to marketing

A

Kefauver-Harris Drug Amendment

30
Q

why is it necessary for manufacturers to demonstrate safety and efficacy of drug before marketing?

A

because of phocomelia secondary to Thalidomide

31
Q

decides which drugs, biologics, and medical devices are safe and efficacious and therefore can be marketed

A

FDA

32
Q

developed a web-based system that offers information about ongoing clinical trials for a wide range of diseases and conditions

A

NIH

33
Q

Search for studies for particular diseases and identify treatment centers that offer enrollment into these studies

A

NIH

34
Q

for the regulatory requirements for drug approval

A

International Conference on Harmonization (ICH)

35
Q

Protection of Human Subjects

A
  1. Nuremberg Code
  2. Declaration of Helsinki
  3. Belmont Report
  4. Code of Federal Regulations
36
Q

judge the human experimentation conducted by the Nazis in the middle of the twentieth century

A

Nuremberg Code

37
Q

voluntary consent of the human subjects is absolutely essential

A

Nuremberg Code

38
Q

re-emphasized protection of human subjects

A

Declaration of Helsinki (1964)

39
Q

basic ethical principles underlying medical research on human subjects

A

Belmont Report (1978)

40
Q

designed to make the protection of human subjects in all federal agencies uniform

A

Code of Federal Regulations (CFR)

41
Q

Drug Approval Process

A
  1. preclinical testing
  2. IND application
  3. phase I to IV
  4. NDA review
42
Q

the application by the study sponsor to the FDA to begin clinical trials in humans

A

IND

43
Q
A

FALSE: not required

44
Q

An IND is not required if the drug is marketed in the USA and all following requirements are met

A

Study…
1. not reported to the FDA in support of a new indication
2. not involve a different dose, route, patient population that increase risk to patients
3. IRB approval and informed consent are secured
4. not used to promote drug’s effectiveness for a new indication

45
Q

IND Contents

A
  1. Cover Sheet (Form 1571)
  2. TOC
  3. Introductory statement
  4. General Investigational Plan
  5. Investigator’s brochure
  6. Clinical protocol
  7. Chemistry, manufacturing and control data
  8. Pharmacology and toxicology data
  9. Previous human experience
  10. Additional information (eg abuse potential, safety)
46
Q

Four types of documents that may be used to amend the IND

A
  1. Protocol amendment
  2. Information amendment
  3. IND Safety Reports
  4. Annual reports
47
Q

Submitted when a SPONSOR WANTS TO CHANGE a previously
submitted PROTOCOL or add a new study protocol to an existing IND

A

Protocol amendment

48
Q

Submitted when INFORMATION becomes available that would not be presented using a protocol amendment, IND safety report, or annual report (e.g., new chemistry data)

A

Information amendment

49
Q

reports clinical and animal adverse reactions; reporting requirements depend on the nature, severity, and frequency of the experience

A

IND Safety Reports

50
Q

describe the progress of the investigation including information on the individual studies, summary information of the IND (summary of adverse experiences, IND safety reports, preclinical studies completed in the last year)

A

Annual Reports

51
Q

Annual reports are submitted within ___________________ of the annual effective date of an IND

A

60 days

52
Q

IND Safety Report contains

A
  1. suspected adverse reactions
  2. serious adverse events or serious suspected adverse reaction
  3. unexpected adverse event or unexpected suspected adverse reaction
53
Q

IND and clinical trial will be assigned to a review team that includes

A
  1. project manager
  2. chemistry, manufacturing, and controls (CMC) reviewer
  3. nonclinical pharmacology/toxicology reviewer
  4. clinical reviewer
  5. other reviewers as needed
54
Q

The FDA has __________________________ of an IND to respond to the sponsor.

A

30 days after receipt

55
Q

The FDA has 30 days after receipt of an IND to respond to the sponsor

A

clinical holds

PHA6123 LEC Pharmacy Informatics (4 decks)

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