module 17 drug regulation and monitoring Flashcards
FDA and CDER
protect public health by assuring the safety, efficacy, and security of drugs
drug discovery
2-5 years
compound identification and optimization
patent application
drug development
5-9 years biological characterization of drug patent granted toxicology studies IND filed - phase 1 and 2 trials -- end phase 2 meeting ---- phase 3 trials ----- NDA filed ------ FDA approval develop manufacturing
post-approval regulation
phase IV
ANDA filed
patent expires -> generics made available
phase 1 trials
small scale: 20-80 healthy volunteers est. safety and tolerability focus overall includes dosing and PK parameters often non-blinded
phase 2 trials
dose selection efficacy inc. number people 50-300 effectiveness of drug for particular disease detecting adverse events single blind trial
phase 3 trials
large scale: 300-3000
clinical or surrogate endpoints
employ randomization, controlled, double-blind trials
results should typically provide adequate basis for extrapolating results to general pop.
preclinical research: purpose and methods
show that the drug is reasonable and safe
- data from in vitro or animal studies
- design studies to provide evidence necessary for administering the compounds to humans
- investigations on absorption and metabolism
- toxicity of drug metabolites
- speed of excretion
- 2 or more species tested
preclinical research: animal testing
short-term: 2weeks-3mo.
long-term: few weeks to several years
- control group or placebo
- compare to current drug
investigational new drug (IND) application
sponsor submits info to FDA who reviews and decided to continue to human trials or not.
- know bias: placebo and drug must look same
ethics in clinical drug investigation
- must minimize the risk for participants
- provisions must be made for overall care of pt
- investigator responsible for terminating the trial when risk becomes higher than benefit
- adverse events must be reported immediately to ethics committee
- data and safety monitoring board reviews safety and efficacy data
institutional review boards
used to ensure the rights and welfare of people participating in trials
clinical trial design must consider and answer
- which prospectively defined outcome variables are feasible to measure and scientifically valid
- whether a control group is possible and what tx to use in control group, if any
- ease with which subjects and investigators may be blinded
- definition and scope of disease
- number of participating trial sites and pts
New drug application (NDA)
from clinical trails -> selling
must provide following info
- drug is safe and effective for proposed use
- drugs proposed labeling is appropriate
- methods used in manufacturing the drug and the control used maintain the drugs quality are adequate to preserve the drugs identity, strength, quality, and purity.
fast track status
accelerated development and approval status for serious and life-threatening disease
