Three basic kinds of drug names:
chemical, conventional, trade
What is the distinction between exchange name & normal equivalent?
Drug formulations no longer usually same however ought to be seventy five%. Fillers might
also cause problems. Important that trade & regularly occurring work the identical.
Measurements of bioavailability may be key.
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OTC Drugs
Legally available with out a prescription.
May have critical aspect consequences if now not used well.
Self-treatment can be ineffective.
Drug Approval & Regulation
Standards - 1800s.
National Drug Acts start in 1902 with Food, Drug & Cosmetic Act in 1938.
DSHEA - 1984.
FDA - 1988
Black field warnings: 1997.
Drug approval process
Controlled with the aid of FDA. Takes about eleven years.
Preclinical investigation - animals.
, Clinical research - human trials
Review of New Drug Application - NDA.
Post-advertising surveillance - iPledge
Therapeutic pills are reviewed in four phases:
· Preclinical research - animals.
· Clinical research - human trials.
· Review of the New Drug Application (NDA)
· Post-marketing surveillance - iPledge
Controlled Substances:
Some capsules have high capacity for abuse.
Dependence –related to addiction: a physiologic or psychologic want for a substance.
Physical Dependence – altered bodily condition due to the adaption of the nervous gadget;
repeated use.
Withdrawal – physical soreness felt whilst a substance is now not to be had.
Controlled Substance Act of 1970
Drugs are in 5 schedules & categorized in keeping with capability for abuse.
Schedule 1: highest ability for abuse. Restricted. Little or no healing value. Heroin, LSD &
marijuana.
Schedule V: lowest ability for abuse.
Controlled Substance Act aka Comprehension Drug Abuse Prevention & Control Act.
Hospitals & pharmacies should check in with the DEA.
Must use an assigned variety to buy scheduled drugs. Must hold entire information of all
portions bought & offered.
Healthcare vendors should additionally sign in in order to prescribe.
Scheduled Drugs
Examples
Teratogenic Risk
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