Study of the biological effects of the chemicals.

Are chemicals that are introduced into the body to cause some sort of change

Two (2) key concerns in clinical pharmacology:

Science which deals with the interactions between the chemical components of living systems and the foreign chemicals including drugs that enter those systems

Involves the study of absorption, distribution, metabolism, biotransformation and excretion of drugs

SOURCES OF DRUGS

Is the oldest source of drugs

The leaves of Digitalis Purpurea are the source of______ which are cardiac glycosides

Leaves of_______ give oil of_______ , which is important of cough syrup

Tobbaco leaves give

______ gives ATROPINE which is anticholinergic

_________________ gives MORPHINE (OPOID)

Are used to replace human chemicals that fail to be produced due to disease or genetic problems

Is a source of Insulin, used in treatment of Diabetes

Genetic engineering, the process of altering DNA, permits scientist to produce human insulin by altering a______bacteria making insulin a better product

______liver is used as a source of vitamin A and D

after a chemical that might have therapeutic value is identified, it must undergo a series of scientific test to evaluate its actual therapeutic and toxic effects

carefully monitors new drug development

This PHASES OF NEW DRUG DEVELOPMENT does test on laboratory animals

Causing adverse effects to the fetus

This PHASE OF NEW DRUG DEVELOPMENT does test on healthy human volunteers

are not good candidates for phase I studies, because the chemicals may exert unknown and harmful effects

This PHASE OF NEW DRUG DEVELOPMENT does trials with people who have the disease which drug is thought to be effective

This PHASE OF NEW DRUG DEVELOPMENT uses drug in vast clinical market for surveillance of drug’s therapeutic effects

This PHASE OF NEW DRUG DEVELOPMEN, the FDA continually evaluates drugs in the market

also called trade or proprietary name, given by the pharmaceutical company that developed it

original designation that the drug company applied for the approval process

reflect the chemical structure of a drug

1930s – the drug ELIXIR (sulfanilamide) was distributed in a vehicle of Ethelyn Glycol which was toxic to humans

1960s - the drug THALOMID, sleeping aid by pregnant women, many babies were born with limp deformities

Prevented the marketing of adulterated drugs; required labeling to eliminate false or misleading claims

Mandated tests for drug toxicity and provided means for recall of drugs; established procedures for introducing new drugs; gave FDA the power of enforcement

Tightened control of certain drugs; specified drugs to be labeled "may not be distributed without a prescription"

Tightened control over the quality of drugs; gave FDA regulatory power over the procedure of drug investigations; stated that efficacy as well as safety of drugs had to be established

Defined drug abuse and classified drugs as to their potential for abuse; provided strict controls over the distribution, storage, and use of these drugs

Provided incentives for the development of orphan drugs for treatment of rare diseases

levothyroxine, folic acid, magnesium sulfate

Metformin, hydrochlorothiazide, cyclobenzaprine, amoxicillin

tramadol, gabapentin, amlodipine, prednisone

Lisinopril, alprazolam, losartan, clonazepam

Lisinopril, alprazolam, losartan, clonazepam

is responsible for the enforcement of these regulations relating to controlled substances

Each prescriber has a ______ which allows the Drug Enforcement Agency to monitor prescription patterns and possible abuse