Study sets, textbooks, questions
Upgrade to remove ads
Terms in this set (59)
agents naturally produced in animal cells, microorganisms, or in the body, including hormones, monoclonal antibodies, and vaccines, and routinely prescribed or administered
biological agents (microbes or toxins) used as a weapon for personal or political agendas. It can range from infecting an individual to people across a country.
Black Box Warnings
the strictest warning on a drug label produced by the FDA when their can be serious side effects.
study of drugs in humans
Complementary and Alternative Medicine Therapies
uncommon medical approaches with less research provided on safety and efficiency.
books with lists of pharmaceutical formulas and substances for concocting medicinal preparations approved for a specific purpose.
drugs that are administered to a patient who is sick or in pain
Natural Alternative Therapies
naturally produced; include herbs, extracts, vitamins, minerals, or dietary supplements; sometimes used, depending on healthcare provider for treatment
Off Label Use
When a drug proves effective for a disease that differs from the one involved in the original testing & FDA approval
Disease that occurs over a wide geographic area and affects a very high proportion of the population.
the study of how disease processes affect the function of the body
the study of how various dosage forms influence the way in which the drug affects the body
study of drugs and their effects on the body
a book, especially an official publication, containing a list of drugs with their effects and directions for use.
branch of pharmacology studying the beneficial and adverse effects of drugs.
location for preparing and dispensing drugs; drugstore
The branch of medicine concerned with the prevention of disease and treatment of suffering.
Congress passed the Food, Drug, and Cosmetic Act. It was the first law preventing the marketing of drugs not thoroughly tested. The law now provides for the requirement that drug companies must submit a New Drug Application to the FDA prior to marketing a new drug.
a group of healthcare providers established the first comprehensive publication of drug standards called the US Pharmacopoeia.
a group of pharmacists founded a national professional society called the American Pharmaceutical Association. The APhA then established the National Formulary, a standardized publication focusing on pharmaceutical ingredients. The USP continues to catalogue all drug-related substances and products.
This was the beginning of the Federal Bureau of Chemistry, established under the administration of President Lincoln. Over the years and with added duties, it gradually became the Food and Drug Administration.
Congress passed the Biologics Control Act to control the quality of serums and other blood related products
The Pure Food and Drug Act gave the government power to control the labeling of medicines.
The Sherley Amendment made medicines safer by prohibiting the sale of drugs labeled with false therapeutic claims.
Congress passed the Public Health Service Act, covering many health issues, including biologic products and the control of communicable diseases.
The US Pharmacopeia and National Formulary announced their union. The USP-NF became a single standardized publication.
Congress passed the Childhood Vaccine Act. It authorized the FDA to acquire information about patients taking vaccines, to recall biologics, and to recommend civil penalties if guidelines regarding biologic use were not followed.
The FDA was officially established as an agency of the US Department Health and Human Services.
Congress passed the Prescription Drug User Fee Act. It required that non generic drug and biologic manufacturers pay fees to be used for improvements in the drug review process.
Congress passed The Dietary Supplement Health and Education Act that requires clear labeling of dietary supplements. This act gives the FDA the power to remove supplements that cause a significant risk to the public.
The FDA Drug Modernization Act reauthorized the Prescription Drug User Fee Act. This act represented the largest reform effort of the drug review process since 1938.
The Bioterrorism Act implemented guidelines for registration of selected toxins that could pose a threat to human, animal, or plant safety and health.
Dietary Supplement and Nonprescription Drug Consumer Protection Act and the FDA Amendments Act revised, expanded and reaffirmed legislation to allow for additional comprehensive reviews of new drugs and medical products. This extended the reforms imposed from 1997. The FDA's Critical Path Initiative was apart of this reform.
Provisions of the Health Care Reform law allowed the FDA to approve generic versions of biologic drugs. Additional drug rebates and benefits were provided to the American public. The FDA Food Safety Modernization Act represents the largest reform effort of food safety review since 1938.
Renewal of the Prescription Drug User Fee Act.
what the body does to the drug depending on absorption, distribution, metabolism, and elimination.
what the drug does to the body when interacting with cellular protein to control changes in physiological function of particular organs.
Drug-Receptor Interactions- binding
Signal Transduction- mechanism of action, pathways
concerned with unusual responses to drugs caused by genetic differences. Side effects, allergies, toxic effects that are produced from the drug in some people and not others.
chemical agents that uniquely interact with specific target molecules in the body, thereby producing a biological effect. Drugs are either stimulatory or inhibitory. Drugs as well as hormones, neurotransmitters, autocoids, and toxins transfer info to cells by interacting with receptive molecules called receptors.
specific receptive molecules. Drugs bind/combine with specific receptors to produce certain responses. This binding takes place with precise physicochemical and steric interactions between certain groups of the drug and receptor.
Law of Mass Action
when a drug (D) combines with a receptor (R) at a rate dependent of the concentration of the drug and the concentration of the receptor.
Naturally produced, including herbs, extracts, vitamins, or dietary supplements, and sometimes recommended, depending on the healthcare provider.
classified on the basis of how they are produced chemically or naturally.
second stage of testing a drug involving testing on humans (usually the longest stage of testing)
discovery phase of chemicals where people formulate, find out how safe or toxic the drug is, and the efficiency of the drug. They do this by animal testing which can be inconclusive as animals bodies don't always act like humans'. Then they get a patent and apply for INDA (Investigational New Drug Application). This stage normally takes one to three years. Effectiveness of a range of drug doses and adverse side effects are determined
NDA Review and Approval
know how the drug works and apply for NDA
Post Marketing Studies
Marketed general use - Safety and toxicity still studied - Companies required to monitor drug effects
Prescription Drugs (Rx)
Need a prescription from a healthcare provider
Advantages: healthcare provider is able to watch over the patient to ensure they're compliant
Therapy can be maximized: proper instruction on drug use can by provided
Not easily obtained
Over the Counter Drugs (OTC):
Can be purchased OTC
Patient self diagnoses their condition for the right medication
Studied long enough with no indication of safety issues
Drug Margin Safety
The difference between a drug's effective dose and a dose that produces more severe side effects
short term lasting 7-14 days
testing that takes up to 30 days
tests lasting longer than 90 days
something which has a positive mental effect, but no physical effect
Investigational New Drug Application
Source of drugs
Plants, Animals, Minerals, Synthetic/Chemical Derivatives, Herbals
Classification of Medicines
Traditional drugs, Biologics, Natural alternatives
Drug Safety: Types of drug Safety Studies
Acute toxicity studies, Sub-chronic toxicity studies, Chronic toxicity studies
Sets with similar terms
Pharm Ch 1
Contemporary Pharmacotherapeutics C352 - WGU
Pharmacy Law Chapter 2
Core Concepts in Pharmacology Ch 1
Other sets by this creator
Liver Project Quizlet
Ch 1 Business and Personal Law
29 Septembre 2017
Other Quizlet sets
CSC 265 Quiz 1
EVOLUTION & DIVERSITY CH. 9
Chemistry 107 Quizzes