Drug Development/ Clinical Trials Flashcards
What is strucure activity relationship and what is it used for
many drugs are synthesized and evaluated by assessing their structure and the biological structure of the biological target
What was sulfonamides originally used for and what are they used for now
known- antibacterial
exploited side effect- reduces blood sugar in type II diabetes
What is preclinical testing and what is it looking for (4)
New drug candiants tested in virtro and animals
- good bioavailability
- long half life (maintain therapeutic window)
- Min side effects
- High margin of safety
What is preclinical ADME
-absorption, distribution, metabolism, excretion in vivo
What is the inital dose given to humans in comparison to animal studies
-usually one-fifth to one tenth of the max tolerated dose in most sensitive animals
What occurs in phase 1 clinical trials
- healthy volunteers
- study single dose at various concentrations, then with multiple doses for duration of expected therpeutic use
What occurs in phase 2 clinical trials
- Studies are conducted in patients with medical conditions to be tx
- can start to compare efficacy and safety with other drugs
What occurs in phase 3 clinical trials
- goal to obtain more safety and efficacy data
- studies conducted on large sample size of pts. to allow statistical evaluation in controlled and uncontrolled trials and compare to other exsisting tx
What occurs in phase 4 clinical trials
after drug in public
-Purpose of phase iv clincial trials is to obtain more data as requested by regulatory agency or for other reasons
-previously unnow drug interactions or better dosing recommendations may be discovered
What is bioequivalence
used to determine bioequivalence bw generic and original drug
What is pharmogenetics
The study of the contribution of genetic factors to variation in drug response and activity
What is pharmacogenomics
The use of genomic information and technologies to create drug based on the genetics first
What are polymorphisms
variations in the human genome that occur with a frequency of greater than 1% is considered as polymorphism and considered sig
What is the clinical sig of antypical plasma cholinersterase
typicall inactivates the muscle relaxant succinycholine (used for surgery)
-in the presence of atypical cholinesterase the mm relaxation action can last for an hour instead if mubutes
What is the clinical sig of a deficiency of acetaldehyde dehydrogenase
nomally alchol is made into acetalydehyde by alcohol dehydrogenase then acetalydehyde is further broken down by acetaludyhde dehydrogenase
-in this case acetaldehyde will build up and produce unplesent side effects
