,8. administration has variable and erratic absorption. n: Rectal
administration
9.4. Steady state (SS): absorption. n is usually reached within 4-5 half
lives of drug.
10.Half-life of a drug is: how long it takes for half the drug to be excreted
from the body. Determines how frequently the drug must be
administered. Predicts how long toxic effects can last.is constant with
first-order pharmacokinetics of a drug.
11.Zero-order (nonlinear) pharmacokinetics: means a drug is metabolized
at a constant rate per unit time.
12.CYP3A4 substrate drugs: may have enhanced activity if any CYP3A4
inducer drugs are used along with it.
13. Drug development process involves these steps according to the FDA:-
: Discovery: laboratory research to develop the new drug. Preclinical
research with animal testing for safety (Phase I). Clinical research on
,human subjects for medication safety (Phase II). Clinical research in
humans comparing the new drug
to accepted medications placebo depending on the study (Phase III).
FDA review of the results to determine approval. Post marketing study
to identify adverse effects not found in earlier clinical studies (Phase IV)
14.2. Medication safety organizations: The Institute for Safe Medication
Practices (ISMP) The Institute of Medicine (IOM) The Joint Commission
The National Coor- dinating Council for Medication Error Reporting and
Prevention (NCC MERP) Food and Drug Administration (FDA) Safe Use
Initiative
15.Two basic type of ADRS:: pharmacological and idiosyncratic.
16.85% to 90% of ADRS: are pharmacological.
17.Adverse drug reactions are usually preventable,: frequently occur in a
hos- pital or nursing home setting, and include medication errors,
adverse drug effects, and allergic idiosyncratic type reactions.
, 18.ADRS are not commonly reported;: the FDA does not mandate that
ADRS be reported.
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