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HOSA PHARMACOLOGY LATEST EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |ALREADY GRADED A+/BRAND NEW VERSION!!!$19.49
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HOSA PHARMACOLOGY LATEST EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |ALREADY GRADED A+/BRAND NEW VERSION!!!
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Course
Nursing
Institution
Nursing
HOSA PHARMACOLOGY LATEST EXAM
ACTUAL EXAM 200 QUESTIONS AND CORRECT
DETAILED ANSWERS WITH RATIONALES
|ALREADY GRADED A+/BRAND NEW
VERSION!!!
NDA Process: New Drug Clinical Trials: Phase I -
Answer--involves 25-100 volunteers
-safety tolerated dosage determined
-identification of major si...
,NDA Process: New Drug Clinical Trials: Phase II -
Answer--involves 100-300 volunteers
-emphasis on the drug effect against what it's
designed to treat
-effets compared with similar patients receiving
different treatments
NDA Process: New Drug Clinical Trials: Phase III -
Answer--involves 300-3000 volunteers
-emphasis on the drugs overall effect
-effects compared with patients taking placebos
-study of different population and different dosages
-testing the drug in combination with other drugs
,-final phase before presenting to FDA for approval
NDA Process: New Drug Post Approval Trials:
Phase IV - Answer--ongoing/post approval trials
-health-care professionals to report any adverse
findings
-lasts eternally, as long as the drug is on the market
NDA Process Time - Answer--can usually take 12-15
years
-patent only last 20 years from the time the
application for patent was filled
, Federal Food and Drug Act of 1906 - Answer--known
as the Pure Food and Drug Act
-provided authority for federal inspection of meat
products and prohibited the sale of adulterated foods
-required that "secret elixirs" containing ingredients
like: cocaine, heroin, morphine and alcohol which
were available at most stores as miracle cure-alls be
labeled with correct information about their
ingredients as well as suggested dosages
-replaced by the Federal Food, Drug and Cosmetic
Act of 1938
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