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Ali Pharm Lecture 1: Pharm for the PT
Terms in this set (65)
Knowledge of the history, source, physical and chemical properties, compounding, biochemical, and physiological effects, mechanisms of action, absorption, distribution, biotransformation, excretion, and therapeutic uses of drugs
Broadly defined as any chemical agent that affects processes of living
Study of the biochemical and physiological effects of drugs and their mechanisms of action
Pharmacotherapeutics ("therapeutics") definition
The use of drugs in the prevention and treatment of diseases
How many names does every drug have?
What is the chemical name of drugs used for?
Used by chemists and drug company (its lengthy and complicated)
What is the generic name of drugs?
Name determined by drug company and United States Adopted Names Council (Official, Non-Proprietary)
Which name (chemical, generic, or trade) is the best identifier of a drug?
What is the trade name of drugs?
Drug company assigns
Registered with US patent Office (Brand, Proprietary)
Drug company is protected by a 20 year patent on any new drug product they develop and is approved but he FDA
What happens when the patent on a drug product expires after 20 years?
Other companies may market the drug as a generic version of the original (and assign their own "trade" name in the process)
Is the patent protection extended if testing/review process of a drug product is delayed? Y/N
Nomenclature of Tylenol
Chemical name: N-acetyl-p-aminophenol
Generic name: Acetaminophen
Trade name: Tylenol
Nomenclature of Prozac
Chemical name: (+/-)-N-Methyl-3-phenyl-3-(alpha, alpha,alpha-trifluorotolyoxyl)propylamine
Generic name: Fluoextine
Trade name: Prozac
Angiotensin receptor antagonists class
Quinolone antibiotic class
Chimeric antibody that responds to more than one antigen
By law, what must be defined before marketing?
Safety and efficacy of drugs
Responsible for monitoring the use of existing drugs as well as the development and approval of new drugs
Pure Food and Drug Act of 1906
Accurate labeling of food and drug products
Harrison Narcotic Act 1914
Initial regulation of addictive drugs
Food, Drug, and Cosmetic Act 1938
Safety, purity, FDA over-sight/authority (no proof of efficacy however)
Amendments to Food, Drug, and Cosmetic Act 1962
Safety and efficacy
Investigational New Drug (IND)
New Drug Application (NDA) procedures
Orphan Drug Amendments 1938
Drugs for rare diseases, tax credits to manufacturers
Drug Price Competition and Patent Term Restoration Act 1984
aNDA for generic drugs, streamlines generic drug approval process
Dietary Supplement Health and Education Act 1994
Defined supplement and labeling requirements
Limited FDA review
Safe, no mis-leading claims, proof of efficacy NOT required
Prescription Drug User Free Act 2007
Shortened drug review time, fee to the FDA to pay for drug approval
What currently make up about 50% of major recalls in the US?
What are examples of "natural states"?
T/F: Natural or organic dietary supplements are free from side effects or interactions
About how long does it take for a new drug to come to market from conception?
How long does clinical testing of a new drug take?
What does it cost to develop and bring a drug to market?
No effect does definition
max dose where specified toxic effect is not seen
LD 50 definition
Median lethal dose in animals
What is the initial human dose?
1/100 to 1/10th of no effect dose
What are some limitations to the pre-clinical safety/toxicity step of the drug approval process?
Large # of animals needed
Animal ---> human extrapolation of data
Once you reach sufficient pre-clinical data, what needs to happen?
File an IND
What do IND's contain?
Composition/source of drug
Chemical and manufacturing info
All data from animal studies
Proposed clinical plans/protocols
Names/credentials of MDs in studies
Key data for investigators/IRBs
If the IND is approved, what happens next
Move onto Phase 1 studies
What does Phase 1 of the drug approval process include?
Small # of healthy human volunteers
Find probable limits of safe clinical dosage range
"Open", "blinded" (placebo controlled)
Pharmacokinetic measurements obtained
What does Phase 2 of the drug approval process include?
Studies in patients with target disease to determine efficacy (100-200 patients)
Placebo, est. active drug, investigational agent comparisons
Broaden range of toxicities detected
Where do we see the highest rate of drug failures in the drug approval process?
How many drugs usually move onto to phase 3 of the drug approval process?
What does Phase 3 of the drug approval process include?
Confirm safety and efficacy
Minimize errors due to placebo effects
Double-blind, cross-over techniques
Design, costs, data collection
If Phase 3 of the drug approval process is successful, what happens next?
File an NDA
How many patients, on average, are needed for data in the NDA?
How long do FDA approvals take?
Priority drugs: ~6 months
Standard drugs: ~10.2 months
What does Phase 4 of the drug approval process include?
Larger # of patients
No fixed duration
What is defined as monitoring safety of the new drug under actual conditions?
What does REMS stand for?
Risk Evaluation and Mitigation Strategy
Adverse drug reactions with 1:10,000 (or less) incidence require what?
Large sample size for detection
Access to ends restricted
Drug only made available through infusion centers registered w/ TOUCH program
Treatment re-authorization every 6 months
Meant to ensure drug is used well
Approximately what percentage of prescriptions in the US are for generic drugs?
Prescription medication implies what?
These meds are not safe to use except under professional medical supervision
Durham-Humphrey Act 1951
Established prescription status
Controlled Substances schedule
Prescription to OTC status conversion process criteria
patient can easily diagnose, treat, and monitor
Low rate of side effects, abuse, toxicity
No specific monitoring/tests involved
Controlled substances definition
Meds deemed to be habit-forming or dangerous are "scheduled" into 5 classes (1 = worst, 5=least dangerous)
Class 1 controlled substances
Not for medicinal use
Class 2 controlled substances
Agents with strong habituation or abuse
Class 3 controlled substances
Codeine + APAP combinations
Class 4 controlled substances
Class 5 controlled substances
Codeine cough syrups
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