Clinical Pharamcology chapter 1 and 2 Flashcards
Pre fda phase is …
In this phase the drug manufactured and tested in vitro (outside the human body)
The pre-fda phase has two stages what are they?
Investigating a new drug : is the phase the drug is tested on public
and new drug application: is the phase where all data is discussed by Heath professionals
FDA phase is
The fda surveillance for the manufacturing company and any new side effects which may arise.
Medwatch system
Is a system for physicians to report any complications from the drug.
Special fda programs
Orphan drug program, accelerated programs and compassionate access to improved drugs.
What is RxNorm system
A system that was developed by the national library.
The norm system
Gives the chemical of the the drug, the brand name,official name, and a short history
What are the drug categories
Prescription drugs, non prescription drugs, and controlled substances.
Controlled substances
Are drugs used with precautions because they can lead to physical and psychological dependence.
What effect does giving drugs to a pregnant women during the first trimester cause
Teratogenic effect
Drug actions within the body
Pharamaceutics phase, pharmacokinetics phase, pharmacodynamic phase.
Pharmaceutics phase
The us the dissolution of the drug.
Pharmacokinetic phase
Metabolic activities within the body after the drug reaches the body
Bioavailability and drug distribution
Is the fraction amount which reaches the body
Metabolism(bio transformation)
Is the process where the liver transforms the drug into metabolites and is called first pass effect
