-
What is Probenecid used for (as discussed in class)?
- To be administered with Penicillin to improve its pharmokinetics and increase its levels and duration
- To outcompete Penicillin for liver enzymes
-
At what date did the current antibacterial discovery void begin?
1987
-
What was the last major discovery in Antibacterials?
Daptomycin
-
Lobar pneumonia has been greatly reduced, due to what type of discovery?
Antibacterials
-
What two antibacterials that were used to reduce Lobar pneumonia were discussed in class?
-
Atacids decrease uptake of what drugs?
Fouroquinolones and acidic drugs
-
Acidic drugs and flouroquinilones are poorly absopbed under what conditions?
Acidic
-
Kids can be treated like small adults in terms of absorbative abilities?
False, children have higher pH in the stomach
-
Geriatrics and children have what similar characteristic in terms of absorption:
Higher pH in stomach
-
What type of drugs enter the brain and humors of the eyes
- most effectively?
- uncharged non-polar drugs
-
uncharged non-polar drugs enter what body parts most effectively?
- The humor of the eyes
- The brain
-
What rules should you follow to determine Placenta or Breast milk transfer?
No rules, need to look up instead
-
In what drug state is elimination most likely to happen?
Most polar state
-
the most polar drug state is the one in which what is most likley to occur?
Elimination
-
Where are uncharged drugs metabolized?
In the liver
-
The liver is the site of metabolism (as a step in elimination) for what type of drugs?
uncharged
-
Metabolism usually does what wo things to drugs?
- Destoxifies
- Decreases activity
-
What general body acitivity reduces drug toxicity and activity?
Metabolism
-
competition between similar molecules for a single enzyme type creates what?
Dalayed elimination
-
Delayed elimination can be caused by what liver enzyme related occurance?
Competition
-
What year did the Sulfanilamide disaster take place?
1937
-
What year did the Federal trade commission ban false advertising?
1914
-
What year was the pure food and drug act put into place?
1906
-
What was the coverage of teh pure food and drug act?
- No saftey or efficacy
- Must report purity
-
What Act required saftey as a prerequisite for sales?
Food and Drug Cosmetic Act 1938
-
What year was the food drug and cosmetic act put into place, requiring drug saftey to be proven?
1938
-
When was the Keefauver and Harris Amendment passed?
1962
-
The Keefauver and Harris Amendment required what new characteristic of drugs?
Safter AND efficacy
-
What amendment (and year it was passed) was responsible for enforcing drug saftey and efficacy?
Keefauver and Harris amendment passed 1962
-
What is the total estimated time for developing a new antibiotic?
9 years
-
What phase of drug develpment takes the longest on average?
Phase III
-
FDA review of new drug application takes approximately how long?
1-2 years
-
What is the shortest phase (and the approx. time in years) of clinical drug trials?
Phase 1, approx. 1 year
-
Phase II of drug trials takes approx. how long?
2 years
-
How long are preclinical studies performed before filing with the FDA?
1 year
-
How long does it take to get to NDA filing in the new drug development process?
7 years
-
What is the first step in the process of developing a new drug?
Drug Discovery
-
What ways do we commonly perform Drug Discovery?
- Soil Screening test
- Chemically alter an existing drug
- Computer modeling
- Buy undeveloped drug from another company
-
What is the purpose of Soil Screening?
To find naturally produced antibacterials
-
What is the first step in drug development?
Preclinical trials
-
What are three components of preclinical trials as outlined in lecture?
- In vitro potency studies
- Large scale production, packaging and stability
- Animal studies for toxicity and efficacy
-
Animal studies for toxicity and efficacy, large scale production and in vitro potency studies are performed during what stage of drug development?
Preclinical trials
-
What is the term for the initial FDA filing for a New drug?
IND or Investigational New Drug Application
-
Phase I of drug clinical trials includes what aspects?
- Pharmacology
- Dosage studies
- Toxicity studies
-
Pharmacology, dosage studies and toxicity studies are performed during what stage of clinical trials?
Phase I
-
What stage of clinical trials includes small groups of humans to obtain data on efficacy and saftey?
Phase II
-
Phase II of clinical trials includes what type of studies?
Small clinical trials on humans to determine saftey and efficacy
-
Phase III studies include what type of testing?
Extensive large scal trials focused on the infections of interest
-
Which phase of clinical trials is extensive and large scale, focusing on infections taht the drug will likely be indicated for?
Phase III
|
|