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Psychopharmacology Test 5 Lecture 3
Terms in this set (41)
Steps of new drug development
-preclinical research and development
-clinical research and development (phase I, II, III)
-permission to market (phase IV)
Preclinical research and development
-synthesis and adequate chemical description
-demonstration of drug safety
-Company applies to FDA for designation of Investigational new drug
How is drug safety demonstrated?
-acute, one time administration of several dose levels to different groups of animals of at least 2 separate species
-drug given regularly to animals (of 2 separate species) for a period related to the proposed duration of use in humans
What must be the same in animal drug research as it would be in humans?
route of administration and drug form
What happens when a company applies to FDA for desingnation of Investigational New Drug (IND)
-all results from preclinical studies
-detailed description of proposed clinical studies
-certify that there will be informed consent
-agree to provide annual post-marketing report (called phase IV) reporting)
Clinical research and development - Clinical trial
studies conducted on human subjects to assess the therapeutic efficacy of an untested drug or other treatment
Clinical research and development Phase I
screening for safety
What questions does screening for safety attempt to answer?
-is it safe for human use?
-how is it absorbed, distributed, metabolized, excreted?
-are there side effects? what are they?
-how much of the drug can be tolerated?
Who are subjects during phase I?
typically healthy, paid volunteers (n=20-80)
What does phase I begin with?
low doses that are gradually increased as the tests proceed
When does phase I end?
after subjects are meticulously monitored and strong adverse reactions are observed
How long does screening for safety take?
Clinical research and development Phase II
establishing the testing protocol
What is the goal of establishing the testing protocol?
-establish the conditions under which the final test will provide a clear result
What questions does establishing the testing protocol answer?
-is it therapeutically effective? at what doses?
-how frequently should they be administered?
-how long do they need to be administered?
-what benefits are likely to occur
Who are subjects in Phase II
patients suffering from the target disorder (N=100-200)
Phase II studies are typically _____________
How long does Phase II take
Clinical research and development Phase III
double-blind placebo-controlled on large numbers of patients (N=1000-5000) suffering from the target disorder based on results from phase II
What is required from Phase III to convince government regulatory agencies?
two independent successful tests
-successful=benefits greatly outweigh adverse side effects
How long does Phase III last
After Phase III, developer files a _____________ with the FDA
New Drug Application
New Drug Application
-contains all data collected to this point
-the FDA makes a decision within 6 months (if yes, drug enters market; if no, more time and energy to fix the issues)
post market reporting
What happens when drug enters market
What are the different drug names
Who assigns the drug chemical name?
Example of drug names
- 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one (chemical name)
-valium (brand/trade name)
-diazepam (generic name)
What does the brand/trade name define?
formulation, gives active ingredients and excipients
Most drugs of abuse are referred to by their ________ name
Controversial aspects of drug development
-double-blind pacebo-control design
-active placebos needed
-length of time for trials too long
-seldom develop drugs for rare disorders
Problem with double-blind placebo-control design
assigned to drug or placebo group randomly
control drugs that have no therapeutic effect but produce side effects similar to those produced by the drug under evaluation
Why are length of trials "too long"
-sick people getting sicker
-only a 20 year patent on new drug
-only 20% of drugs entering phase I ever gain final approval
-from 1994-2003, FDA approved an average of only 32 drugs per year
Why are drugs seldom developed for rare disorders?
-orphan drug act passed in 1983 gives tax incentives and exclusive sales rights for 7 years
drugs for which the market is too small for them to be profitable because they affect no more than 200,000 people
-billions spent on new drugs
-average time to approval = 15 years
-way more failure than success
For every one drug approved =
-250 enter clinical testing
-5 enter clinical trial (final testing)
More about clinical trials
-the process is far from perfect but it works
-they can be trustworthy, fast, or cheap, but in any one trial only two of the three are possible
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