CH 2 Drug Regulations Flashcards
The second stage of drug testing in a clinical investigation; involves the testing of a new drug in selected patients:
Clinical phase trials
In the US, a drug whose use is restricted by the Comprehensive Drug Abuse Prevention and Control Act:
Controlled substances
A powerful physiological or psychological need for a substance:
Dependence
List of drug and drug recipes commonly used by pharmacists:
Formulary
Application to the FDA that contains all the animal and cell testing data:
Investigational New Drug (IND)
Application submitted to the FDA that signals that the pharmaceutical company is ready to sell the new drug:
New Drug Application (NDA)
Medications that are truly unique and structurally different from existing drugs:
New molecular entities
Serious, though rare, disease that affects less than 200,000 people in the US:
Orphan disease
Orphan Drug Act of 1983 offers drug manufacturers grants and/or tax credits to to recoup the costs of their research and developmental costs due to it not being cost effective since these diseases are so rare.
The rise of these drugs was seen in early America, they contained a brand name that clearly identified the product
Patent medicines
A medical reference summarizing standards of drug purity, strength, and directions for synthesis:
Pharmacopeia
In drug testing, an inert substance that serves as a control “nontreatment” group used to compare the effectiveness of the new drug:
Placebo
Stage 4 of the drug approval process during which testing is done to survey for harmful drug effects in a larger population:
Postmarketing surveillance
The first stage of drug development that involves extensive laboratory testing by the pharmaceutical company on human and microbial cells:
Preclinical research
Drugs that have significant potential for abuse are place into five categories, called:
Schedules
These are referred to as scheduled drugs. They are classified and regulated according to their potential for abuse. Highest abuse potential is I, Lowest is V.
US regulatory agency responsible for ensuring that drugs and medical devices are safe and effective:
U.S. Food and Drug Administration
These clinical phase trials are the longest part of the drug approval process and occur in sequential stages. Stage 1 involves?
Testing is conducted on 20 - 80 healthy volunteers for several months to determine proper dosage and to assess for adverse effects.
The focus is on safety.
If unacceptable levels of toxicity are noted, the clinical trials are stopped.
This stage involves several 100 patients with the disease to be treated.
Stage 2 of clinical phase trials.
Focus is on effectiveness of the new drug and is compared to a placebo or a standard drug used for the same condition.
This stage involves large #’s of patients with the disease and are given the drug to determine patient variability:
Phase 3 of clinical phase trials.
Potential drug-drug interactions are examined. Patients with chronic conditions (cardiac, renal, or hepatic impairments) are given the drug to determine safety in these important populations.
