University:
University of Wolverhampton
Course:
4PY019 | Pharmacy
Academic year:

2024
Views:

201

Pages:

3
Author:

Sara

Discovery and development Preclinical research Clinical research FDA drug review FDA post-market and safety marketing 5 steps of drug development process 1- instrument, apparatus, implant, drug accesory (insulin pump) 3 types of medical devices that require 2- intended for use in diagnosis, cure, or FDA approval and an example of each prevention (hospital masks, gowns) 3- intended to affect structure or function of the body (breast implants) New insights to disease 3 instances that may lead to the discov- Tests of molecular compounds ery of a new drug Existing treatments with unanticipated effects What is researched during the development stage of R &D? Absorption in the body, dosage, best form of drug, side effects, interactions with other drugs Preclinical research tests to see if a drug has the potential to cause serious harm, or ____________ Toxicity in vitro Outside an organism (Petri dish, test tube) In vivio Inside a living organism In silico On computer 4 types of clinical trials Treatment trials Prevention trials Quality of life trials Diagnostic trials The coordinator Project manager Reviews the preclinical trial Pharmacologist Reviews all clinical study info Medical offices Interprets data from the trial Statistician 1/3 Evaluates the molecular compound of the drug and the quality of manufacturing of the drug Chemist Focuses on how the drug processes through the body Pharamkineticist Is the expert if the trial has any anti microbial indications Microbiologist How many things make it past all stages 1 out of 10,000 After what phase is a drug approved by the FDA? Phase 3 The complete timetable from research and development of a drug to mass marketing is how many years 12 Inactive drug used during a clinical trial Placebo 2 disadvantages of using placebo in clinical trials Ethical issues- lack of treatment Patients may not enroll in the trail if known What is the difference between a placebo and a sham drug? Sham looks like the real drug 3 common groups compared to one another in a clinical trial Control group Placebo group Experimental group Single Blind Study vs. Double Blind Study in a single blind the experimenter knows but the participants does not and in a double blind they both don't know. Single adv- simple design, disadv- patient may under or over report effects Double adv- no researcher bias, disadv- reduces researcher ability to monitor safety of treatments placebo effect psychological benefit from a compound that may not have the chemical structure of a drug effect Phase 1 clinical trials 2/3 Drug tested for safety on 20-100 people over several months 70% pass rate Phase 2 clinical trials Tested for efficacy and side effects, refines research, on several 100 people for up to 2 years, 33% pass rate Phase 3 clinical trials Efficacy and monitoring of adverse reactions on 300-3,000 people, 1-4 yrs, 25-30% pass rate Phase 4 clinical trials Safety and efficacy, several thousand people, lasts forever, drug is passed 3/3