Core Concepts - Chapters 1-5 Flashcards
What are therapeutics?
The branch of medicine concerned with the prevention of disease and treatment of suffering.
Pharmacology
Study of medicine. Derived from Greek words.
What is pharmacotherapy?
Or pharmacotherapeutics, the application of drugs for the purpose Of disease prevention and the treatment of suffering.
WHat are the three categories that therapeutic purposes fall under?
- drugs or medication
- biologics
- complementary and alternative medicine (CAM) therapies.
What is a prototype drug?
The well-understood drug model with which other drugs in its representative class are compared. - by learning characteristics of prototype you can predict the actions and adverse reactions of other drugs in same class.
What are the three basic types of drug names?
Chemical, generic and trade names.
What is a drug?
A chemical agent capable of producing biological responses within the body. These responses may be desirable ( therpeutic) or undesirable (adverse).
What is a medication?
It’s a drug after its been administered. Drugs are considered to be medically therapeutic.
What are biologics?
Agents that naturally produce in an animal cells, by microorganisms, or by the body itself.
Examples are: hormones, monoclonal antibodies, natural blood products and components, interferons, and vaccines.
Biologics are used to treat a wide variety of conditions.
What are Complementary and alternative medicine (CAM) therapies?
Is another therapeutic approach. These involve natural plant extracts, herbs, vitamins, minerals, dietary supplements, and many techniques considered by many to be unconventional.
Other therapies: acupuncture, hypnosis, biofeedback, and massage.
What was the first standard of drug regulations used to protect the public?
The formulary, a list of drugs and drug recipes.
What was the first comprehensive drug standards in the United States?
u.s pharmacopeia, established in 1820.
What is a pharmacopeia?
A medical reference summarizing standards of drug purity, strength and directions of synthesis.
What is the food and drug administration (FDA)?
Established in 1988, an agency of the U.S. Department of Health and Human services. The center for drug evaluation and research (CDER), a branch of the FDA exercises control over whether prescription drugs and OTC drugs may be used for therapy.
What are boxed warnings?
Created by the FDA in order to regulate drugs with “special problems”.
What are lack box warnings?
A primary alert for identifying extreme adverse drug reactions discovered during and after the review process.
What are the four phases in which therapeutic drugs and biologics are reviewed?
- Preclinical investigation
- Clinical investigation
- Review for the new drug application (NDA)
- Post marketing surveillance.
What is involved in preclinical investigation?
Extensive laboratory research where scientist perform test on human and microbial cells cultured in the laboratory. Studies are performed on many species of animals to examine the drugs effectiveness at different doses and to look for adverse effects.
What is evolved in the clinical investigation phase?
Takes places in three different stages called the clinical phase trials. Clinical phase trials are the longest part of the drug approval process.
Test first performed on volunteers. Then large groups of selected patients with the particular disease.
What is the third phase of the drug approval process?
It’s the NDA review. During this stage the drugs brand name is finalized
What is the final phase of the drug approval process?
It is post marketing surveillance which begins after clinical trials and the NDA review has been completed. The purpose of this phase is to survey the harmful drug effects Ina a larger population.m
