Pharmacy Practice and Ethics

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Questions and Answers

What is the primary focus of Phase 1 of a drug trial?

Pharmacokinetics and metabolism

Optimal dosage strength

Effectiveness of the drug

Safety of the drug (correct)

How many participants are typically involved in Phase 2 of a drug trial?

5000-10,000 patients

100-300 individuals with the target disease (correct)

1000-3000 patients

20-80 healthy volunteers

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

To test the drug on healthy volunteers

To test the drug on animals

To request FDA approval for marketing a drug (correct)

To test the drug on patients with the target disease

What percentage of drugs typically pass Phase 1 of a drug trial?

70% Signup and view all the answers

What is the primary role of the FDA?

To review and approve new drugs Signup and view all the answers

What is the first step in the FDA drug development process?

Discovery and Development Signup and view all the answers

What is the primary goal of laboratory research in the drug development process?

To discover and research promising compounds Signup and view all the answers

What is a common reason for drug failure?

High toxicity Signup and view all the answers

What is the purpose of preclinical studies in the drug development process?

To determine the efficacy and safety of the drug Signup and view all the answers

How long does Phase 1 of a drug trial typically last?

1 year Signup and view all the answers

What is the average time it takes to develop a new drug from the laboratory to the pharmacy shelf?

12 years Signup and view all the answers

What is the average cost of developing a new drug from the laboratory to the pharmacy shelf?

$350 million Signup and view all the answers

What is the next step after finding a lead compound in the drug development process?

Begin preclinical research Signup and view all the answers

What is the focus of Phase 2 of a drug trial?

Effectiveness Signup and view all the answers

How many patients are typically involved in Phase 3 of a drug trial?

1000-3000 patients Signup and view all the answers

What is the purpose of an Investigational New Drug (IND) application?

To outline the proposal for human testing in clinical trials Signup and view all the answers

What percentage of compounds that begin laboratory testing will progress to human testing?

1 in 1000 Signup and view all the answers

What is the purpose of clinical drug development?

To fine-tune the drug for human use Signup and view all the answers

When does the patent period for a new compound begin?

When the patent application is filed Signup and view all the answers

What happens if the FDA determines that a drug is 'approvable'?

The sponsor is required to submit additional information Signup and view all the answers

How many critical steps are there in the U.S. drug development process?

5 Signup and view all the answers

What is the purpose of Phase 1 clinical studies?

To test the efficacy of the drug on healthy volunteers Signup and view all the answers

What is the first step in the drug development pathway?

Preclinical phase Signup and view all the answers

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

To request FDA approval for the drug Signup and view all the answers

What is the purpose of FDA Post-Market Safety Monitoring?

To monitor the safety of the drug after its release Signup and view all the answers

What is the purpose of the investigational new drug (IND) application?

To begin clinical testing Signup and view all the answers

What is the last step in the FDA drug development process?

FDA Post-Market Safety Monitoring Signup and view all the answers

What happens after a drug is approved by the FDA?

The drug performance is resubmitted to regulatory agencies Signup and view all the answers

What is a possible reason for the FDA to reject a new drug application?

Inadequate drug performance Signup and view all the answers

What is the purpose of Phase 4 - Post-Market Safety Monitoring?

To continually assess the safety of the drug Signup and view all the answers

What may be included in a Supplemental New Drug Application (SNDA)?

Changes in labeling or formulation Signup and view all the answers

What type of change requires prior FDA approval in a SNDA?

Change in the method of synthesis of the drug substance Signup and view all the answers

What is the purpose of an Abbreviated New Drug Application (ANDA)?

To approve a generic drug product Signup and view all the answers

What is a requirement for a generic drug product in an ANDA?

Scientific demonstration of bioequivalence Signup and view all the answers

What is not required in an ANDA?

Preclinical and clinical data to establish safety and effectiveness Signup and view all the answers

What is a possible consequence of inadequate drug performance?

FDA rejection of the new drug application Signup and view all the answers

What is the purpose of Phase 4?

To monitor the safety of the drug Signup and view all the answers

What type of change does not require prior FDA approval in a SNDA?

Change in the analytical methods to comply with USP/NF Signup and view all the answers

Study Notes

Drug Development Process

The development of new drugs is a complex and costly process, taking an average of 12 years and about $350 million to get a new drug from the laboratory to the pharmacy shelf.
Only one in 1000 compounds that begin laboratory testing will progress to human testing.
The patent period for a new compound begins on the date that the patent application is filed with the relevant patent office.

Phases and Stages of Drug Development

There are five critical steps in the U.S. FDA drug development process, including many phases and stages within each of them.
The phases of drug development are:
- Step 1: Discovery and Development
- Step 2: Preclinical Research
- Step 3: Clinical Development
- Step 4: FDA Review
- Step 5: FDA Post-Market Safety Monitoring

Discovery and Development

Drug discovery research is how new medications are discovered.
Investigate chemical libraries, including small molecules, natural products, or plant extracts, and find those with therapeutic effects.
The drug discovery process gets narrowed when one lead compound is found for a drug candidate, and the process of drug development starts.

Preclinical Studies

Once a lead compound is found, the preclinical phase of drug development begins with in vivo research to determine the efficacy and safety of the drug.
Preclinical trials test the new drug on non-human subjects for efficacy, toxicity, and pharmacokinetic (PK) information.
These trials are conducted by scientists in vitro and in vivo with unrestricted dosages.

Investigational New Drug (IND)

Investigational New Drug (IND): Application for permission to administer a new drug to humans.
Outlines the proposal to use the new drug for human testing in clinical trials.
Studies in humans can only begin after IND is reviewed and approved by the FDA and an institutional review board (IRB).

Clinical Drug Development Process

Once preclinical research is complete, researchers move on to clinical drug development.
This includes clinical trials and volunteer studies to fine-tune the drug for human use.

Clinical Studies

Phase 1: Efficacy studies on healthy volunteers (typically 20-80 healthy volunteers, no women of childbearing potential).
Phase 2: Clinical studies on a limited scale (typically 100-300 individuals who have the target disease).
Phase 3: Comparative studies on a large number of patients (typically 1000-3000 patients).
Phase 4: Continued comparative studies, registration, and market introduction.

New Drug Application (NDA)

Pre-NDA period: FDA and drug sponsors meet.
Submission of NDA: Formal step asking the FDA to consider approving a drug for marketing.
FDA has 60 days to decide whether it will file it for approval consideration.

FDA Review

The review team evaluates the research on the safety of the drug and its effectiveness.
The FDA reviews the information to go on the drug label.
It inspects the facilities where the drug will be manufactured.

Reasons for Drug Failure

Toxicity: If the toxicity of a new drug is too high in human or animal patients, the drug may be rejected due to safety concerns about its use following manufacture.
Efficacy: If a new drug's efficacy is not high enough or evidence is inconclusive, the FDA may reject it.
PK Properties or Bioavailability: PK causes of drug failure include inadequate action duration and unanticipated human drug interactions or poor bioavailability.
Inadequate Drug Performance: If the new drug performs the desired function, but only at a shallow level, the FDA may reject the application in favor of a formulation that performs better.

Phase 4 - Post-Market Safety Monitoring

Post-market surveillance of the drug to continually assess the safety of the drug.
May include incidence and severity of rare adverse reactions, cost-effectiveness analyses, comparative trials, and quality-of-life studies.

Supplemental New Drug Application (SNDA)

A sponsor of an approved NDA may make changes such as labeling or formulation.
Depending on the changes proposed, some require FDA approval before implementing; others do not.

Abbreviated New Drug Application (ANDA)

Application for generic drugs previously approved by NDA.
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.
Do not require to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.

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Description

This quiz covers pharmacy practice, ethics, and history, focusing on the drug development process and education requirements. Part of the PHAR250 course at Lebanese International University.