INTRO TO PHARMA LEC

Pharmacology

is the study of drugs and their effect on living systems

medicine

may contain one or more active constituents of drugs together with additives to facilitate administration

Blind study

only the researcher knows who is given sugar drugs

Double blind study

researcher and other individual are aware of who has been administered sugar drugs, but the researcher does not know the identity of the other person

Local anesthetics

what are administered before extraction?

Generic name

-becomes the official name of the drug -used by United States Pharmacopeia -Available globally -Shorter and categorizable

Pre-clinical studies

-from in vitro (test in cells) to in vivo (test in living organism) -takes about a year to gather data

Clinical trials

-has 3 phases -researchers still use human volunteers to test -clinical trials show us what works and what doesnt

Trade name

-if the chemical name is therapeutically useful and is to be marketed commercially, the company gives the drug their trade name -registered trademark and becomes the property of the registering company -has strict quality control

Formulary

-predominance of pharmacists -includes information of drugs in the respective countries

Pharmacopeia

-predominance of physicians -official code containing a selected list of established drugs

FDA review/approval

-reviews all data, including the drug label, and inspects the facility in which the drug will be made -during this inspection, officers inspect and observe records of the production process and collect samples to protect human safety -upon approval, the fda grants an exclusivity period or exclusive marketing rights, ranging from 6 months to 7 yrs

Phase 1: Clinical trial

-test on a healthy individual (20-100) -test for safety, dosage, and side effects -3 years -include Pdynamics & Pkinetics of the drug

Phase 2: Clinical trial

-test on larger groups of affected individuals (100-300) -test for efficacy and side effects, further evaluates safety -5 years -Placebo effect

Chemical name

-used during the time when the drug is being investigated for possible clinical use -not used to identify drugs in a clinical or marketing situation

Diagnosis, Prevention, Contraception, Treatment

Uses of drugs

FDA post market monitoring

-Begins after the drug receives approval in order to monitor long term effects, observe if new side effects appear over time, and determine if the drug increases patient's lifespans -this phase is especially important for drugs that received accelerated approval and therefore had shorter clinical trials

Drug discovery and development

-Discover a certain chemical that would target a particular tissue or would have an effect in a particular disease -typically takes time and effort -should have fewer side effects and should act in the specific target -usually takes about 4-5 years

Phase 3: Clinical trial

-Tested on new and wider demographic (1-2k) -Test for long term effectiveness and comparison with other medications -8 yrs -Basis for approval (Pivotal trials)

extraction cases

In dentistry, drugs are commonly used in __ cases

Generic Act if 1988 or R.A. 6675

an act to promote, require, and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic name

Placebo

anything that seems to be a "real" medical treatment but isn't

drugs

are chemical substances that affect the biologic system