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Terms in this set (320)
the study of drugs and their interactions with living
Pharmacology
systems
Clinical Pharmacology Study of drug effects in humans
Contraindications factors that prevent the use of a drug or treatment
Significant adverse effect Reaction we DON'T want (usually unexpected)
Indication Therapeutic effect (Primary)
Psychology, pathology,
Pharamacology requires
anatomy/physiology,biology,biochemistry,medical
knowledge of
chemistry and microbiology
The process by which a medication works in certain
Pharmodynamics
area of the body.
the study of drugs within the body, absorption ,
Pharmokinetics
distribution, metabolism, excretion
location for preparing and dispensing drugs; also the
Pharmacy
study of preparing and dispensing drugs
Agents produced from microorganism actions or by the
Biologics
body
Study of drugs from herbal or natural sources (Ex: Aloe,
Pharmacognosy
Poppy Seeds)
Posology Study of drug dosage
Any agent producing biological responses. Intended to
Drug
improve physiologic condition or kill pathogens
Medication A drug administered to a patient
Study of how drugs are best used
Pharmacotherapuetics
Which drug is appropriate for a specific disease
,Adverse effect An undesired unpredicted drug response
CAM Complementary and alternative medicine
-Legal drugs authorized by health practitioners for a
specific patient
Prescription Drug
-Has exact dosage so it doesn't interfere in other
factors
Pharmacist specialist in preparing and dispensing drugs
-over the counter drugs
-does not require a prescription
OTC
-dosage instructions must be followed
-may not be potent enough to treat a condition
-Food and Drug Administration
-Focuses on the use of safe/effective drugs
FDA
-approves all marketed drugs including biologics,herbal
products,dietary supplements and vaccines
CBER Center for Biologics Evaluation and Research
CFSAN Center for Food Safety and Applied Nutrition
National Center for Complementary and Alternative
NCCAM
Medicine (for CAM therapies)
1)Preclinical Investigation
2)Clinical Investigation
Drug Approval Phases
3)Review of New Drug Application (NDA)
4)Post-marketing Surveillance
-1 to 3 years to complete (18 months average)
Preclinical Investigation -Animal pharmacology for toxicology data
(Phase 1) -Cultured cells,animal studies also used for extensive
research in laboratory
-20 to 100 human volunteers,doses increase
Clinical Investigation (Part 1
-Safety is determined,70% of drugs move on to next
of Phase 2)
phase
-several dozen to 300 volunteers
Clinical Investigation (Part 2
-Investigational new drug application (INDA) is
of Phase 2)
submitted to FDA for approval
, -Trade name is finalized
-FDA makes initial review with 6 months
Review of NDA (Phase 3)
-If approved, trials/testing continues
-If rejected, manufacturer addresses concerns
-Begins after clinical trials and NDA review
Post-Marketing -Annual FDA meetings to receive patient and health
Surveillance care professional's feedback
-FDA can still withdraw drugs
1)Diagnosis of disease
2)Prevention of disease (Immunization/vaccine)
5 Therapeutic uses of the
3)Cure of disease (antibiotics/chemotherapy)
drug
4)Contraception
5)Alleviation of symptoms of disease (painkillers)
-must meet certain criteria
-to ensure:strength,composition,quality
Drug Standards
-if standards aren't met then drug may vary in
strength/activity
1)United States Pharmacopeia (USP)
2)National Formulary (NF)
-Both updated every 5 years
Official Compendia -Uses generic drug names
-Used by drug manufacturers
-Lists Physical/chemical properties of drug
-Drug selection:Therapeutic value/low toxic effect
-The study of what the drug does to the body (both
therapeutic and adverse effects)
Pharmacodynamics -Biochemical,physiologic effects of drugs
-essential for safe prescribing,use and evaluation of
responses
-Unofficial
-Listed drugs by manufacturer
Physician's Desk Reference
-Updated yearly
(PDR)
-Used by pharmacists,nurses and physicians
-Has 6 color-codes sections
-Determined by pharmacokinetics and
pharmacodynamics
Dose-Effect Relationship
-relationship between dose that produces harmful
effects