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Module 1: Intro to Pharmacology
Terms in this set (49)
Through the 1970's, most drug discoveries were based on the identification of ___________ with medicinally active compounds.
How successful was the 1950's method of traveling to South America to find new plants and trying to isolate any active compounds within them?
-very low success rate
-what little success it did have was based on shear luck
What is drug design?
-designing drugs to alleviate illnesses based on factors that cause certain illnesses
-became popular in the 1970-80's
The search for a drug to decrease cholesterol levels without significant side effects is a good example of _______________ .
-summary: studied how the body makes/uses cholesterol, identified different steps of making it, isolated an acid & enzyme, used computers to find a drug to inhibit the enzyme, found a fungus that inhibited it, identified which chemical in the fungus did this, further analyzed this chemical & improved its effects, then animal testing was done
When testing a potential new drug, how many species of animals must it be tested on? Why?
3+ species because the effect may be different
Why is animal testing done before releasing a new drug? (3)
-identify the potential of the drug
-identify side effects
-determine a safe dose
It is estimated that only ______ in 5,000 compounds make it to human testing, and only ______ of them may be safe & effective enough to reach pharmacy shelves.
-5 in 5,000
-only 1 of the 5
What is targeted drug discovery?
-the researcher knows the target molecule that they want to affect
-they find/create a compound that will have the desired effect
How successful has targeted drug discovery been?
-they thought it would increase the liklihood of finding new drugs, but it has been quite poor in reality
-in 2010, phenotypical drug discovery was developed to replace this
What is phenotypical drug discovery?
-scientist no longer knows the target molecule
-instead, they know what the end effect should be & search for drugs that produce this final effect
Ex: diabetes researcher may look for a drug that increases the release of insulin from pancreatic islets
Why were pharmaceutical companies hesitant to make anti-HIV drugs more widely available?
-these drugs have to be taken daily, exactly the way they were prescribed
-otherwise this could result in a resistant form of HIV which would be devastating to the efforts made to cure the disease
What is the name of the U.S. government agency responsible for ensuring that drugs marketed in the U.S. are safe and effective?
(food & drug administration)
On average, it takes a drug _____ years to go from drug discovery to the market.
A new compound is typically tested on isolated cells in culture. This allows the investigator to identify what aspects about the drug? (2)
-effect of the drug at a cellular level
-determine dose at which the drug is toxic to cells
Is drug testing completed on isolated cell cultures or animals first?
cell cultures, then they apply for approval for animal testing
The FDA has little to do with early or late stages of drug testing?
early, they become involved when drug testing has been completed in animal models and is ready for human testing
What is the best way to determine the effects of a new drug?
controlled clinical trials
What is a controlled clinical trial?
researchers observe patients receiving a new drug compared to patients receiving a placebo
What is the only legal way for the FDA to conclude that a new drug has shown "substantial evidence of effectiveness"?
controlled clinical trials
What happens in phase I of a controlled clinical trial?
-drug is given to small # of healthy volunteers.
-assess most common acute adverse effects and examine doses that patients can take safely w/out high amt of side effects
What must be true before drug testing can progress from phase I to phase II of a controlled clinical trial?
the testing did not reveal any major problems such as unacceptable toxicity
What happens in phase II of a controlled clinical trial?
-drug is given to people w/ condition the drug is intended to treat
-but only to a few patients
-if this goes well, progress to phase III
What happens in phase III of a controlled clinical trial?
-large # of participants with disease of interest
-effect of drug is not always easy to assess
-drugs rarely miraculously reverse fatal illnesses, but instead reduce risk of death, and reduce symptoms
What happens in phase IV of a controlled clinical trial? What is this phase called?
(a.k.a. postmarketing surveillance)
-begins once drug is approved to market
-monitor any problems that occur
What impact have lobbying groups had lately on the time required for a drug to be approved by the FDA?
their efforts have reduced this time
-FDA is making an effort to get more drugs to market with less regulatory burden (more like Europe and Canada)
In the history of pharm lecture, how is thalidomide used as an example of why animal testing is necessary?
-wasn't FDA approved
-never legally sold in U.S. but was in Asia
-only tested on rats which were immune to the toxic side effects
if it had been tested on more animal species, toxic effects would have been seen
-consequence: many kids in Asia were born with terrible deformities
The FDA realizes 15 years is too long to wait for some drugs to reach market. What effort did they make to help alleviate this problem?
-added a new way to categorize drugs as either standard or priority
: provides minor improvements over an existing drug
: believed to have advances in health care & move more quickly through the approval process. Still have to go through 3 phases of human testing
A recent change in pharmacy is from the "one drug for all" concept to ___________________ instead.
What is personalized medicine?
-we each have different genetics that affect how drugs work in our bodies
-a drug could be altered/developed, based on our DNA, to work best for us
Personalized medicine has a long way to go, right now only the ______________ field is regularly using this approach.
What is a blinded study?
-patients receiving the drug don't know if they are getting the placebo or drug & neither does the physician
-the effects for the experimental and control groups are compared
Why don't blinded studies work well to test personalized medicine?
because the drug has been personalized for each patient so people are on different doses or different alterations of the drug
How does personalized medicine affect physical therapy?
-patients who are on the same drug might have different side effects from the drug since it has been "personalized" for each patient
-PT will have to keep track of a lot more drug information
What is tissue regeneration?
-new field where new organs are grown
-sample is taken either from the patient or stem cells to grow the tissue
-if it is taken from the patient there is no chance of tissue rejection
How will tissue regeneration affect physical therapy?
-much of our chronic care business will go away
-treat pt after transplant initially, but then they will be fixed
What is the chemical name of a drug?
-name reflecting its molecular structure
-long & cumbersome name
What is the generic name of a drug?
-shortened version of chemical name
-often as a variation of chemical name
-also called nonproprietary
What is the trade name of a drug?
-also called brand name or proprietary name
-assigned by pharmaceutical company
-identifies drug as exclusive property of the company
-usually does not relate to chemical nature of drug, but is catchy & easy to remember
When a drug is first made by a pharmaceutical company it is protected by a __________ typically for 20 years. What does this mean?
-means other companies can't make/sell the drug
After the patent for a drug expires, what happens?
-other companies can start selling the drug as a generic version or they can make their own trade name
-original company can also keep selling drug under original trade name
When can a trade name exist for a drug but not a generic name?
-during the time that the drug is under patent
-would happen if the original company decided to use a trade name
Can a drug have more than one trade name or generic name?
Are generic or trade drugs less expensive?
generic b/c companies that sell these drugs have lower expenses in bringing the drugs to market
What are the Merck Index and the Physician's Desk Reference (PDR) ?
the 2 traditional drug references
(used to look up drug info)
Which traditional drug reference is considered to be for chemists and provides the full chemical name and structure of a drug?
Which traditional drug reference is commonly seen in rehabilitation departments?
the PDR (Physician's Desk Reference)
Most drug references include dosing regimes, since PT's do no prescribe, why is this information needed?
-only important when you suspect improper intake of drugs by your patient
What does the therapeutic category of a drug tell us?
-describes what effect the drug is expected to have (Ex: diuretics)
-includes side effects of a drug
Irina cautions you from looking up drugs on any website b/c anyone can put anything on the Internet. She lists lots of websites that she likes as drug references like the FDA
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