Therapeutics, Drug Development Flashcards
Drugs in children
Pharmacokinetics or Pharmacodynamics are not well defined in children?
_______ enzyme systems are not fully developed in infants, especially premature infants.
Some differences exist when it comes to _______ as compared to adults
Pharmacokinetics
Hepatic
clearance
Drugs in children
What is Gray baby syndrome?
What enyme system, in infants, is immature and incapable of mtabolizing the excessive drug load?
what antibiotic is not usually given to newborns or premature babies?
rare but serious side effect that occurs in newborn infants following the I.v. administration of the antibiotic chloramphenicol. There is blue discoloration of skin and lips (cyanosis) and cardiovascular collapse.
UDP-glucuronyl transferase enzyme system.
chloramphenicol
Drugs in the elderly
about __% of population is over the age of 65 yrs
they take __% of perscription drugs
They take an average of __ drugs per patient
they report __% of drug adverse reactions
14%
33%
5
25%
Physiologic changes in the elderly:
there are 4. What are they?
Ga
Bf
GFR
H
what do each of these cause?
- reduced gastric acidity and GI motility –> causes decrease in absorption of some drugs
- Increased body fat –> Increased Vd (especially for lipid soluble drugs)
- Reduced GFR <glomerular> (0.5%per year) --> decreased clearance (of water soluble drugs)</glomerular>
- Reduced hepatic blood flow –> decreased clearance of some drugs
Drug Development
preclinical development is where drugs are tested on?
What drug development includes multiple phases? and how many?
What event takes place before marketing development?
What drug development includes phase 4 and has doctors looking for adverse side effects?
How long is the patent life? what happens after that?
animals
Clinical development - 3 phases (before release)
submission to regulatory agency (FDA)
Marketing development
20 years , drug is availible in generic form
Drug development
Preclinical studies last how long?
How long do clinical studies last?
Phase 1 - constist of what?
1-5 years - 2.6 yrs on ave.
2-10 years - 5.6 on ave.
normal volunteers, special populations (renal, hepatic impairment) , safety, biological effects, metabolism, kinetics, drug interactions are studied by clinical pharmacoligists.
Drug development
Phase 2 contains what?
Phase 3 contains what?
After Phase 3 what must be submitted?
in selected patients, therapeutic efficacy, dose range, kinetics, metabolism are studied by clinical pharmacologists and clinical investigators.
carried out in large sample of selected patients (2000-3000) - safety and efficay are studied by clincial investigators
New drug application (NDA) submission and reveied by regulatory authority (FDA) and takes an ave of 12months
Drug development
What happens in Phase 4?
Define ________ - adverse reactions, patterns of drug utilization, additional indications discovered - by all physicians.
(takes place in P4)
What must be submitted prior to clinical studies?
patients given drug for therapy
Postmarketing surveillance
an investigational new drug application (IND)
