Intro to pharmocology- Dr. Pechnick Flashcards
what is pharmacology
the study of interaction with of drugs with living biological systems.
A pharmacologist researches and invents new drugs for the ____ to dispense
pharmacist–> deals with end products of pharmaceutical industry. Namely mix, supply, and advise dosages of drugs
What are the two closely related areas that pharmacology can be divided into
- Pharmacokinetics
2. Pharmacodynamics
Pharmacokinetics deals with the absporption, distribution, metabolism and ____ of drugs
excretion; what the body does to the drug
Pharmacodynamics is the study of the molecular, biochemical and physiological effects of drugs on cellular systems and their mechanisms of action:
what the drug does to the body when it gets there
How are drugs discovered?
- by screening natural products. Ex: curare
- testing herbal/traditional medicine. Ex: curcuma longa/turmeric
- molecular modeling: shows 3 dimensional structure of enzyme and try to get drug to fit in pocket.
- Combinatorial chemistry and high throughput screening: prepare parent compound in test tube and make analogs and screen compounds but have to know what your looking for
- me too drugs
- son of a drug
- repurposing/repositioning:
What are “me too” drugs
Anti depressant drugs; SSRIs
what are ex of “me too” drugs
- prozac
- celexa
- lexapro
- paxil
- zoloft
pharmacology is the same but small differences
what is “son of a drug”
- Resolve and separate enantiomers: prilosec/nexium
2. active metabolites: seldane/allegra
what is repurposing/repositioning
same drug, but used for a new use
How did drug laws come into place
Pure Food and Drug Act of 1906:
- Proof of efficacy/safety not required
- required proper labeling
- limited interstate transport of misbranded/adulterated drugs
* Led to the creation of the FDA
Food Drug and Cosmetic Act of 1938
- Proof of safety was required
- Proof of efficacy not required.
- Toxicity testing required in animals
- A new drug application had to be filed with the FDA prior to approval
What is thalidomide
A drug marketed primarily in Europe in 60’s as a tranquilizer for pregnant women who had nausea. 2,000 children and serious birth defects in more than 10,000 children
*teratogenic
What is Harris Kefauver Amendment of 1962
- Both safety and efficacy had to be proven
- Required documentation of risk to benefit ratio
- Gave the FDA authority to regulate advertising
- began to classify all pre 1962 drugs already on the market as effective, ineffective or needing further study.
What are the various phases of drug testing
- preclinical testing:
- Phase I
- Phase II
- Phase III
- Phase IV
what are the goals of drug development
- inc efficacy
- work faster
- easier to take
- fewer adverse reactions (side effects)
- fewer drug-drug and drug-food interactions
- profit
what is the preclinical testing phase
invitro, in vivo
- establishes a “proof of concept”
- file for investigational new drug (IND)
- time required to comp: 3-6 years
what is Phase I testing
- uses normal volunteers
- determines safety and biological effects
- efficacy is not studied
- assesses pharmacokinetics (absorption, distribution, metabolism, and excretion)
Time required to complete: months- 1 year
what is Phase II testing
- Studies a small number of patients with the targeted disease
- Efficacy is established
- Pharmacokinetics characterized
- dose range is determined
- short term side effects and risks are assesed
time req to complete: 1-2 years
what is Phase III testing
- most costly phase
1. large, multi site sample of patients
2. safety and efficacy established
3. drug-drug interactions assessed
4. risk-benefit info generated
5. Time req: 3-5 years
FDA review can take:
1-2 years
how long does it take to develop a new drug and receive approval
12 years
how long are drug patents for
20 years
What is the total cost to develop a single drug
$186 million to 2.6 billion
