6- drug development Flashcards
what are the five major goals turning a drug candidate into a product?
- documentation
- determine safety
- confirm activity
- large scale manufacture (process)
- formulation (pill, liquid, patch, spray)
what are the three aspects of document and patents?
- all research subject to regulatory scrutiny
- all data will be sent to the FDA
- patent coverage
what is a patent, and what are the two things that can be patented?
- document that gives you the right to prevent others from taking your ideas, machine, process, composition of matter
- first thing that can be patented: process, machine, manufactured product, composition of matter
- second thing that can be patented: chemicals (compound, process of making and method of using the compound)
what are the three requirements of a patent?
- novelty (something made / discovered for the first time)
- utility (must be able to be used for some purpose)
- non-obvious
what are the three things you should do regarding your ideas?
- Keep a book of your ideas
- Sign and date your idea
- Have a witness sign and date your idea
what is the purpose of process chemistry?
Establish method of large-scale synthesis because reactions do not work the same way on large scale as they do on small scale
what are the two problems with process chemistry?
- Heat transfer is the major problem
- Cost, environment and toxicity
what are the purification methods of process chemistry?
- Crystallization
- Distillation
what is process chemistry regulated by?
Good Laboratory Practice (GLP)
what are some ways that companies can optimize synthesis for the lowest cost?
- Cost of goods
- Energy costs
- Equipment costs
- Labor costs
- Cost of waste disposal
- Safety costs (certain reactions are dangerous to carry out)
- Transportation costs
what are the three components of reliability with respect to FDA requirement of large scale synthesis?
- Consistent yield
- Consistent purity (97% of purity)
- Consistent purity profile (same impurities in same proportions every time)
describe the process of safety testing i in-vitro, including what to look for
- done in glass
- Use as many biochemical assays as possible
- Look for a “clean” profile (Minimum number of positive results (<300))
- Look for “deal-breakers” (carcinogens and serious interference with organ function)
describe the process of safety testing ii in-vivo::
inside a living thing, using smallest animals possible. this is because it costs less, requires less drugs. need two species, at least one primate
what is the breakdown of animals used per year?
60 million total, 30 million are rodents, 200 thousand are dogs, and 50 thousand are primates
what is the sulfanilamide tragedy?
no testing was done
what is the thalidomide disaster?
result of limited testing
what kinds of experts conduct ethical reviews on animal testing?
health and ethics experts
what happens if no animal tests are done?
their asses get sued
what are the two things involved in the form of the final product?:
the active pharmaceutical ingredient and excipients
what are the eight types of common excipients?
stabilizers, preservatives, fillers, disintegrants, binders, flavors, colours, lubricants
what are the nine types of formulation?
pills, capsules, liquids, topical cream, patch, injectable liquid, nasal spray, eye drops, suppositories
what are the most convenient forms of dosing?
pills, capsules, liquids
what is the difference between the amount of documentation between the IND and the drug entering clinical trials?:
IND is less than clinical. its asking for permission to enter clinical trials
what are least convenient forms of dosing? what is the advantage?:
topical cream, patch, injectable liquid, nasal spray, eye drops, suppositories the advantage is that these forms bypass the liver
