Quiz 4.5 Drug Development Process

When is the IND submitted to the FDA?

After the preclinical studies

Which institutions or companies can sponsor clinical studies? Select the most correct answer.

-pharmaceutical company

-other private or public investigation

-academic institution

-governmental agency

Once the drug has been approved, the sponsor's investigation of the drug ends.

false

When developing the pharmaceutical formulation, each drug candidate's chemical and physical properties must be considered. These include ___.

all of the above properties

The sponsor initiates clinical investigations prior to submitting the IND.

false

Phase III trials have to be controlled:

true

The final dosage form that is submitted to the FDA for marketing approval is developed before ___ .

Phase III

The goal of Phase II controlled trials is mainly to determine ___ of the drug.

efficacy

The starting point in drug optimization is the identification of a ________ compound.

lead

Preclinical testing includes studies in ___ .

animals

Identify all main purpose(s) of Phase III trials.

efficacy

dosage

safety

Select some examples of information that may emerge during Phase III trials?

-additional drug-drug interactions

-new therapeutic use

-additional side effects

-better understanding of the mechanism of action

Human testing can occur before the IND is filed.

False

For orally administered drugs, excipients are usually added to the used dosage form during Phase 1.

False

Patients with the disease intended to treat are participation in ___ trials. Select all correct options.

Phase II

Phase III

Preclinical studies analyze ADME of the drug. What does ADME stand for?

Absorption; Distribution; Metabolism; Elimination

For the FDA approval of a generic drug, ___ needs to be filed.

Abbreviated New Drug Application (ANDA)

How many patients are usually included in Phase III trials?

800-2000

Why is drug solubility important to evaluate?

-Solubility affects the response to the drug.

-Insoluble drug may have erratic or slow absorption.

If a new use, a new strength, a new dosage form, or a new route of administration is discovered in Phase III studies, what must the sponsor do?

submit SNDA

The goal of Phase I is mainly to ___.

To access safety

The participants in Phase II trials are ___ .

patients with the disease intended to treat

Identify the correct statement(s) regarding the IND.

-One of he purposes of IND approval is to ensure that the clinical investigation plan is well established and will fulfill the set objectives.

-The IND summarizes the results of preclinical studies.

-One of the purposes of IND approval is to ensure the safety and rights of the human subjects.

There is a preapproval inspection by the FDA of the facility in which the drug will be produced.

True

The goal of Phase I is mainly to ___ .

assess safety

After the start of marketing of a drug product, the FDA requires ___ .

-plant inspections

-compliance with quality standards and good manufacturing practices

Drug testing in human subjects usually starts before the IND is filed.

False

The final dosage form that is submitted to the FDA for marketing approval is developed before ___ .

In Phase I, the participants are usually ___ .

healthy volunteers

IND stands for ___ .

Investigational New Drug

The overall benefit-risk ratio of the drug is evaluated in Phase III.

True

What is the main purpose of Phase III trials?

A, B, and C

A company wants to use a new dosage form of their approved drug. They need to file ___ with FDA.

Supplemental New Drug Application (SNDA)