Drug Discovery phase
this is when many (5,000) compounds are tested
Pre clinical
250 compounds tested
-used to determine risks and benefits
clinical trials
- 5 compounds used
- split into 3 phases
- 1: 20-100 male volunteers
- 2:100-500 volunteers
3: 1000-5000 - final test to prove safety and efficacy
in order to go from clinical trials to FDA review
-you need an NDA
IND (investigational new drug application
- required to be filed with the FDA before starting clinical trials
- FDA makes suggestions for trial design
phase 4
- safety and efficacy tests done after approval
- off label side affects and uses of the drug are discovered at this time
- this can also be done when the patent for a drug has ran out and the generic brands are designed
expenditures vs approvals
- approvals for new drugs have flattened
- expenditures on discovering and processing new drugs has gone way up
most of the new drugs coming out on the market now are
incrementally modified, not new drugs
what does risk evaluation and mitigation strategies include?
- medication guides
- dear provider lettes
- scheduled advertising
- special training to use the drug
- applicable for about a third of the new molecular entities
what happened in the 1900’s
- federal food and drug act
- designed to prevent interstate commerce of adulterated food, drug, and beverage
what happened in the 1930’s
food and drug act amended to include safety precautions for sulfanilamide and diethylene glycol and how they should not be used
what happened in the 1960’s
- Kefauver-Harris amendment to food, drug and cosmetic act
- this was in response to thalidomide and laid the basis for the stringent efficacy testing that drugs need to go through now which are the 3 phases
what happened in the 1990’s
- mean drug review time is 3 years
- Prescription drug user fee act which requires the developer of the drug to pay a fee to accomodate the amount of work done by the FDA to approve the drug and shorten the review time
mean review time in 2010
1.2 years
DSHEA
- dietary supplement health and education act
- amendment to food, drug, and cosmetic act
- 1994
- to establishstandards with respect to dietary supplements
Rx drugs under the DSHEA act
- deemed safe and effective for intended use in humans prior to approval
- strict labeling includes info on indications, safety, efficacy
- usually 1 but sometimes 2 or 3 ingredients per pill
- label indicates exact ingredients
- potency and purity ensured
dietary supplements under the DSHEA act
- Considered safe unless proven unsafe
- labeling not allowed to make disease treatment or prevention claims
- typically many active ingredients
- labels may or may not contain all ingredients
sources of drug information
- primary: full text or original research about a drug or drug class.
- sencondary/tertiary: not an original work but a summary of it
alternative sources of information
- internet
- professional organization
- drug information centers, poison control centers
- drug manufacturers
MA drug schedules
1: high potential for abuse; no accepted medical use
2: high potential for abuse; currently accepted medical use
3-5: lesser potential for abuse
6: all other prescription drugs (penicillin)
pregnancy risk categories
A: adequate studies in women have failed to show any risk to fetus in 1st tri or later
B: animal studies do not indicate risk and no controlled human studies OR animal studies do show harm, but well controlled studies in women do not
C: studies have shohwn teratogenic or embryocidal effects in animals, but no controlled studies in humans have been done OR no studies available in animals or women
