Drug Development and Approval Process

These flashcards cover key vocabulary terms and concepts associated with drug development and the approval process, highlighting important phases, testing methods, and regulatory classifications.

In Vitro

Testing done in a controlled environment outside of a living organism, typically in a test tube.

High Throughput Screening

An automated process that allows the testing of many samples simultaneously to determine biological activity.

Phase I Trials

Initial testing phase for drugs involving healthy volunteers to assess safety and metabolism.

Phase II Trials

Testing phase where the drug is administered to patients who may benefit to evaluate its efficacy and monitor side effects.

Phase III Trials

Large-scale testing of a drug's effectiveness and long-term side effects conducted on thousands of patients.

Double Blind Study

A clinical trial design where neither the participants nor the researchers know who receives the treatment or the placebo.

Teratogens

Substances that cause developmental abnormalities in the fetus, increasing the risk of birth defects.

Drug Schedule System

Classification system by the DEA that ranks drugs based on their potential for abuse, from Schedule I (highest) to Schedule V (lowest).

Off-Label Use

Prescribing a drug for a purpose other than what it was originally approved for.

Patent Thicket

A situation where numerous overlapping patents cover various aspects of a drug, extending market exclusivity for the manufacturer.

Evergreening

The practice of extending patent protection on a drug by making slight modifications or introducing new formulations.

Idiosyncratic Effects

Unusual reactions to drugs that occur in a small number of individuals, often not predictable based on known effects.

Category A Drugs

Drugs deemed safe for use in pregnancy, with well-controlled studies showing no significant risk.

Category X Drugs

Drugs considered to have a high risk of causing birth defects and should not be used in pregnant women.

What is In Vitro testing?

Testing done in a controlled environment outside of a living organism, typically in a test tube.

What does High Throughput Screening refer to?

An automated process that allows the testing of many samples simultaneously to determine biological activity.

What occurs during Phase I Trials?

Initial testing phase for drugs involving healthy volunteers to assess safety and metabolism.

What is the purpose of Phase II Trials?

Testing phase where the drug is administered to patients who may benefit to evaluate its efficacy and monitor side effects.

What characterizes Phase III Trials?

Large-scale testing of a drug's effectiveness and long-term side effects conducted on thousands of patients.

What is a Double Blind Study?

A clinical trial design where neither the participants nor the researchers know who receives the treatment or the placebo.

What are Teratogens?

Substances that cause developmental abnormalities in the fetus, increasing the risk of birth defects.

What is the Drug Schedule System?

Classification system by the DEA that ranks drugs based on their potential for abuse, from Schedule I (highest) to Schedule V (lowest).

What does Off-Label Use mean?

Prescribing a drug for a purpose other than what it was originally approved for.

What is a Patent Thicket?

A situation where numerous overlapping patents cover various aspects of a drug, extending market exclusivity for the manufacturer.

In Vitro testing is typically done in and is conducted outside of a living organism.

a controlled environment

High Throughput Screening allows the testing of many samples to determine biological activity.

simultaneously

Phase I Trials involve volunteers to assess the safety and metabolism of a drug.

healthy

Teratogens are substances that increase the risk of by causing developmental abnormalities in the fetus.

birth defects

The Drug Schedule System ranks drugs based on their potential for , with Schedule I being the highest.

abuse

In Vitro testing is typically done in and is conducted outside of a living organism.

a controlled environment

High Throughput Screening allows the testing of many samples to determine biological activity.

simultaneously

Phase I Trials involve volunteers to assess the safety and metabolism of a drug.

healthy

Teratogens are substances that increase the risk of by causing developmental abnormalities in the fetus.

birth defects

The Drug Schedule System ranks drugs based on their potential for , with Schedule I being the highest.

abuse