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43 Cards in this Set

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APPROVABLE LETTER
LETTER SENT BY THE FDA TO THE APPLICANT INICATION WHETHER THE APPLICATION OR ABBREVIATED APPLICATION FOR A PRODUCT SUBSTANTIALLY MEETS THE NECESSSARY REQUIREMENTS.
FAST-TRACK DRUGS
FAST-TRACK APPROVAL IS PROVIDED FOR DRUGS THAT MEET UNMET MEDICAL NEEDS FOR PATIENTS WITH SERIOUS OR LIFE THEATENING CONDITIONS.
PLACEBO
A PLACEBO IS A INACTIVE PILL,LIQUID OR POWDER THAT HAS NO TREATMENT VALUE.
PLACEBO EFFECT
THE EFFECT PRODUCED BY A PLACEBO DUE TO THE EXPECTATION OF THE PATIENT. THIS IS COMPARED WITH THE ACTIVE TREATMENT GROUP.
CONTROL OR CONTROL GROUP
A CONTROL IS THE STANDARD BY WHICH EXPERIMENTAL OBSERVATIONS ARE EVALUATED. IN MANY CLINICAL TRAILS ONE GROUP WILL BE GIVEN AN EXPERIMENTAL DRUG OR TREATMENT WHILE THE CONTROL WILL BE GIVEN A STANDARD TREATMENT OR PLACEBO.
BLINDED OR MASKED STUDY
A BLINDED OR MASKED STUDY IS ONE IN WHICH PARTICIPANTS DO NOT KNOW WHETHER THEY ARE IN THE EXPERIMENTAL OR THE CONTROL GROUP IN A RESEARCHSTUDY
DOUBLE BLIND OR DOUBLE-MASKED STUDY.
IS A RESEACH STUDY WHERE NEITHER THE PARTICIPANTS NOR THE STUDY STAFF KNOW WHO IS RECEIVING THE EXPERIMENTAL OR STANDARD OR PLACEBO TREATMENT.
ASYMPTOMATIC
WITHOUT SIGNS OR SYMPTOMS OF DISEASE.
EDEMA
SWELLING
INDICATION
IN TERMS OF DRUG APPROVAL, THE EXACT CAUSE OR PURPOSE FOR WHETHER A DRUG IS APPROVED BY THE FDA TO BE PRESCRIBED
INSTITUTIONAL REVIEW BOARD
"IRB"
A COMMITTEE OF PHYSICIANS, STATISTICIANS,COMMUNITY ADVOCATES, AND OTHERS,WHICHENSURES THAT A CLINICAL TRAIL IS ETHICAL AND THAT THE RIGHTS OF THE STUDY PARTICIPANTS ARE PROTECTED.
OFF LABEL
USAGE OF MEDICATION FOR PURPOSES OTHER THAT SPECIFIC ONES APPEARING IN THE LABELING.
TOXICITY
THE EXTENT,QUALITY,OR DEGREE TO WHICH A SUBSTANCE IS POISONOUS OR HARMFUL TO THE BODY.
ANATOMY
THE STUDY OF THE BASIC STRUCTURE OF THE BODY
PHYSIOLOGY
THE STUDY OF HOW BODY STRUCTURES FUCTION
CLINICAL PHARMACOLOGY
THE STUDY OF THE EFFECT AND MOVEMENT OF DRUGS IN THE BODY
CELL MEMBRANE
SEMI-PERMEABLE MEMBRANCE THAT WRAPS ALL CELLS.
THE NUCLEUS
THE BRAIN OF THE CELL THAT REGULATES ALL ACTIVITIES.
CYTOPLASM/PROTOPLASM
THE SUBSTANCE INSIDE THE OUTER MEMBRANE AND OUTSIDE THE NUCLEUS. CONTAINS MOSTLY INTERCELLULAR FLUID.
EXTRACELLULAR FLUIDS
BODY FLUID LOCATED BETWEEN OR OUTSIDE OF CELLS. EG. INTERSTITIAL FLUID, INTRAVASCULAR FLUIDS AND PLASMA
TISSUES
A GROUP OF SIMILARLY SPECIALIZED CELLS THAT PERFORM THE SAME FUNCTION. EG. ORGANS, TENDONS, MUSCLE,BRAIN LUNGS..
ORGANS
SPECIALIZED CELLS AND TISSUES GROUPED TOGETHER TO PERFORMA SPECIFICBODY FUNCTION. KIDNEY, HERT, INTESTINES,SKIN ETC
3 MUSCLE TYPES
SKELETAL(V), SMOOTH(IV), CARDIAC(IV)
VOLUNTARY(V) AND INVOLUNTARY(IV)
PLASMA
THE LIQUID PORTION OF THE BLOD THAT CARRIES PROTEINS AND OTHER SUBSTANCE.
PROTEIN
MADE UP OF CHAINS OF AMINO ACIDS, SOME KNOW A ESSENTIAL AMINO ACIDS.(MEAT,FISH NUTS)
FATS
STORED IN SPECIAL BODY TISSUESAS GREAT SOURCE OF RESERVE ENERGY
CARBOHYDRATES
THE BODY'S IMMEDIATE SOURCE OF ENERGY.
VITAMINS
SUBSTANCES NECESSARY FOR GROWTH,DEVELOPMENT AND NORMAL REGULATION OF METABOLOLIC PROCESSES.
MINERALS
SUBSTANCE NECESSARY FOR BODY PROCESSES SUCH AS THE BALANCE OF BODY FLUID, THE FORMATION AND MAINTENANCE OF BONES TEETH AND PROPER FUNCTIONING OF MUSCLES..EG. CALCIUM, POTASSIUM,IRON SODIUM
CARDIOVASCULAR SYSTEM
CONSISTS OF THE HEART AND BLOOD VESSELS.
THE RESPIRATORY SYSTEM
CONSIST OF THE NASAL PASSAGES,TRACHAE, THE DIAPHRAGM AND THE LUNGS.
THE GASTROINTESTINAL SYSTEM
CONSIST OF THE MOUTH, ESOPHAGUS, STOMACH,LIVER,PANCREAS,GALLBLADDER,SMALL AND LARGE INTESTINES.
THE NERVOUS SYSTEM
CONSIST OF THE BRIAN, SPINAL CORD AND NERVES
THE MUSCULARSKELETAL
CONSIST MOSTLY OF THE MUSCLES,THE BONESA
THE IMMUNE SYSTEM
CONSIST OF THE LYMPH NODES, VESSELS AND CELLSITS MAJOR PURPOSE IS TO MAINTAIN THE INTERGRITY OF THE BODY BY ATTACKING AND REMOVING INVADING FOREIGN SUBSTANCE AND MICROBES.
BASIC CLINICAL PHARMACOLOGY

3 THINGS
1) ABSORPTION
2) DISTRIBUTION
3) EXCRETION
HOME0STASIS
THE STATE OF CONSTANT, CONSISTENT AND BALANCED INTERNAL ENVIRONMENT IN THE BODY
3 MAIN CONCEPTS IN BASIC CLINICAL PHARMACOLOGY
1) DRUG DISTRIBUTION AND ELIMINATION
2)PHARMACODYNAMICS
3)PHARMACOKINETICS
DRUG DISTRIBUTION AND ELIMINATION
DRUG DELIVERY SYSTEM, ROUTE OF ADMINISTRATION,MODE OF EXCRETION
PHARMACODYNAMICS
STUDY OF THE BIOCHEMICAL & PHYSIOLOGICAL EFFECT OF DRUGS AND THEIR MECHANISMS OF ACTION."HOW A DRUG WORK IN THE BODY TO PRODUCE VARIOUS THERAPEUTIC EFFECTS"
PHARMACOKINETICS
STUDY OF HOW A DRUG IS PROCESSED BY THE BODY AND EMPHASIS ON THE TIME REQUIRED FOR ABSORPTION, DURATION OF ACTION DISTRBUTION IN THE BODY AND METHOD OF EXCRETION."WHAT HAPPNES WHEN IT HIT THE BODY"
ANTAGONIST
Biochemistry. A chemical substance that interferes with the physiological action of another, especially by combining with and blocking its nerve receptor.
AGONIST
Biochemistry. A drug or other chemical that can combine with a receptor on a cell to produce a physiologic reaction typical of a naturally occurring substance.