session 2 practice problems

What is the role of the FDA’s Center for Drug Evaluation and Research (CDER) in the drug development process?

 

Conducting clinical trials

 

Funding drug research

 

Marketing new drugs

 

Overseeing the approval process of new drugs

 

Approving new drug patents

Overseeing the approval process of new drugs

Which of the following is NOT typically included in preclinical studies for a new drug?

 

Pharmacology

 

Marketing strategy

 

Toxicology

 

Drug metabolism

Marketing strategy

What must a sponsor file with the FDA before a new drug can be tested in humans?

 

Investigational New Drug (IND) Application

 

New Drug Application (NDA)

 

Clinical Trial Application (CTA)

 

Marketing Authorization Application (MAA)

 

Supplemental New Drug Application (SNDA)

 

Investigational New Drug (IND) Application

What is the primary purpose of a New Drug Application (NDA)?

 

To begin preclinical testing

 

To obtain funding for drug development

 

To start Phase I clinical trials

 

To file for a new patent

 

To gain permission to market the drug product in the United States

 

To gain permission to market the drug product in the United States

Which of the following changes can be made through a Supplemental New Drug Application (SNDA)?

 

Change in the method of synthesis

 

Change in the drug's therapeutic use

 

Change in the drug's branding

 

Change in the drug’s patent

 

Change in the drug’s chemical structure

Change in the method of synthesis

The transition from 'New Chemical Entity' to initial dosage form for clinical trails takes place during:

 

Formulation

 

Preformulation

 

Clinical trials

 

Good Manufacturing Practices

 

Discovery

Formulation

A New Drug Application precedes an Investigational New Drug Application.

 

True

 

False

False

A sponsor will get a notification from the FDA if their IND is approved.

 

True

 

False

False

Which of the following is not part of preformulation study?

 

Drug metabolism.

 

Drug solubility

 

Stability

 

Dissolution rate

Drug metabolism

Phase II clinical studies focuses on monitoring side effects in a big population.

 

True

 

False

False

Which example may meet the FDA definition of a new drug without being a New Chemical Entity (NCE)?

A. A newly identified lead compound entering discovery

B. An active ingredient that has never been marketed in the United States

C. A new dosage form of a previously marketed active ingredient

D. A compound selected for additional laboratory screening

A new dosage form of a previously marketed active ingredient

Which study is part of preformulation rather than the biological portion of preclinical testing?

A. A 90-day toxicity study in animals

B. A reproductive toxicity study

C. Measurement of the drug’s partition coefficient

D. A genotoxicity study

Measurement of the drug’s partition coefficient

The FDA acknowledges receipt of a sponsor’s IND application. When may the sponsor normally begin the proposed human studies?

A. Immediately after FDA acknowledgment

B. After 30 days, unless the FDA issues a clinical hold

C. Only after all three clinical phases are completed

D. Only after the NDA is approved

After 30 days, unless the FDA issues a clinical hold

A clinical study enrolls approximately 200 patients to continue evaluating safety and obtain initial evidence of effectiveness. Which phase is this?

A. Phase I

B. Phase II

C. Phase III

D. Phase IV

Phase II

A sponsor wants to study a new route of administration for a drug that is already FDA-approved. Which regulatory pathway is required according to the lecture?

A. No additional FDA submission

B. An NDA only

C. A Supplemental NDA only

D. A new IND followed by a new NDA

A new IND followed by a new NDA