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Flashcards in Drug Regulation Deck (12):

What portion of drug regulation does the federal government administer?

The federal government, through the FDA, classifies drugs as prescription, over the counter, or dietary supplements. It also awards patents and patent extensions to drug developers and manufacturers.


What portion of drug regulation do the states administer?

The state governments determine who may prescribe these drugs through the issuance of medical licenses to physicians.


What are the four categories of drugs?

Prescription Drugs, OTC Drugs, Dietary Supplements, and Controlled Substances. Some compounds may fall into different categories depending on their formulation, such as calcium supplements (Dietary Supplement) and injectable calcium (Prescription only).


What is a common feature in drugs with high abuse potential (controlled substances)?

They activate psychological reward pathways.


What is the legal (U.S.) definition of a drug (as opposed to a dietary supplement)?

A DRUG is defined as a therapeutic agent designed to diagnose, treat, cure, or prevent a disease. DRUGS are known molecular entities. Manufacturers of drugs are required to demonstrate proof of efficacy and safety before marketing them to the public.


How many people has a drug typically been tested on before it is approved but the FDA, and what it a drawback to this number?

All three phases of testing combined with total approximately 1000-3000 patients. This is too a small number of patient exposures to detect rare (<1:1000) adverse reactions.


What are the goals and methods of Phase I testing?

Determine the safe clinical range and the pharmacokinetics. Small number of healthy volunteers (20-100, typically male 20-45 y/o). Safety - Determine maximum tolerated dose, may use volunteers with disease if high toxicity is expected. Pharmacokinetics - determine Absorption, Half-life, and Elimination/metabolism, toxic metabolites?


What are the goals and methods of Phase II testing?

Determine whether it works in patients. Describe the specific disease it will be tested on. 100-300 patients with that disease. Single blind testing. Safety and efficacy evaluated, final dosing and regimen determined, may detect a broader range of toxicities.


Where does the term "non-inferior" come from?

Phase III trials for drugs that would compete with other established drugs for a treatable condition (such as HIV) cannot be tested against placebo. It would not be ethical to enroll patients with the disease and then administer placebos to half of them, thus they are given the current treatment instead. The new drug must be tested against the group receiving established care, and positive results for the new drug are termed "non-inferior" to the existing treatment.


What are the goals and methodology of Phase III testing?

Determine whether it works in larger, double blind studies. 1000-3000 patients in normal clinical settings, efficacy measured against established therapy, monitoring adverse reactions from chronic use. Phase III may be omitted for drugs used in life threatening illness (HIV, cancer) and receive an accelerated/conditional approval. Definitive clinical trials must be completed after initial approval.


How is testing on seldom tested populations often achieved?

The FDA will offer to extend the patent on a drug if the company conducts the testing on populations (elderly, children, pregnant women) that are frequently excluded from clinical trials. The additional patent time offered by the FDA will exceed (or far exceed) the expense of the trial.


How many patients are required to detect a 2 fold increase in potential side effects?

Approximately 1800/(incidence in %):
1:100 incidence = 1800 patients
1:1000 incidence = 18000 patients
1:10000 incidence = 180000 patients
Thus, low incidence drug effects will be missed in normal clinical trials.