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36 Cards in this Set

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What phase is disintegration/dissolution of a dosage form considered to be in when a drug is administered?
pharmaceutical phase
What phase is ADME considered to be in when a drug is administered?
pharmacokinetic phase
What phase does the drug-target interaction occur in when a drug is administered?
pharmacodynamic phase
What does ADME stand for?
absorption
distribution
metabolism
excretion
What is biopharmaceutics?
the study of the relationship between the nature and intensity of the biological effects produced in humans (or animals) AND the physicochemical properties of the drug formulation adminstered
Factors of interest in biopharmaceutics include what?
1. the stability of the drug
2. the release of the drug from the product
3. the rate of dissolution or release at the site of absorption
4. the systemic absorption of the drug
What is pharmacokinetics?
"movement of the drug"

mathematical analyses of the time courses of ADME

the relationship between the administration of the drug, the time course of its distribution and the concentration attained in different body regions
What are the 3 aspects of pharmacokinetics?
experimental
theoretical
clinical
What is included in experimental aspects?
-development of biologic sampling techniques
-development of assay methods for drugs and metabolites
-development of data collection and manipulation techniques
What is included in theoretical aspects?
-models that predict drug disposition following drug administration
-classical pharmacokinetics: model development and parameter estimation
What is included in clinical aspects?
-patient specific considerations
-optimized dosing strategies
-therapeutic drug monitoring for drugs with narrow therapeutic index
-pop'n pharmacokinetics: age, gender, ethnic, genetic considerations
For most drugs, you will get a _____ relationship
linear
When and why do you get nonlinear pharmacokinetics?
nonlinear pharmacokinetics occur at toxic doses due to saturation of enzymes and other molecules involved in normal processes
The relationship between the concentration of the drug at the site of action and the pharmacologic response is called what?
pharmacodynamics
What are the 2 methods of obtaining biological specimens?
1. Invasive "poking": blood, spinal fluid, tissue biopsy, and synovial fluid

2. Non-invasive - no intrusion
saliva, milk, urine, feces, and expired air
What is the AUC?
"area under the curve)

measures the amount of drug the patient has been exposed to
What is plasma concentration useful in determining?
optimization of individual dosage
What is a disadvantage of tissue concentrations as a drug concentration assay?
blood flow and drug concentrations are not uniform within tissues
Urine concentration of drug is an indirect indication of what?
systemic concentration of the drug
What does fecal drug concentration indicate?
lack of absorption after oral dose administration or biliary secretion after systemic absorption
What provides a good indication of drug levels in the body?
saliva concentrations taken after equilibrium with plasma drug concentrations
What are the 3 pharmacokinetic concepts?
1. model
2. pharmacokinetic parameter
3. pharmacokinetic functions and prediction
What is a model?
a construct that uses mathematical terms to concisely describe quantitative relationships
A model can be used to do what? (7 things)
1. predict plasma, tissue, or urine drug concentrations over time
2. optimize dosage regimen for individual patient
3. corrlate drug concentration with pharmacologic or toxicologic effects
4. estimate possible accumulation of drugs/metabolites
5. evaluate bioequivalences
6. explain drug interactions
7. describe how physiology or disease affects ADME of a drug
What is a pharmacokinetic parameter?
a constant for a given drug determined from experimental data
What are pharmacokinetic functions?
relationship between an independent variable and a dependent variable

can be used to describe and predict drug concentrations in the body over time
What are the 2 types of models?
1. Physiologically based models
2. Compartmentally based models
What are physiologic models based on?
actual anatomical and physiological data
Where are physiologic models are used more: industry or clinical?
industry
Where are compartment models used more: industry or clinical?
clinical
What is a compartment in the context of compartment models?
a tissue or tissue group that has similar blood flow and drug affinity
What are the 2 types of compartment models?
1. Mammillary
2. Catenary
What is a one compartment system mammillary model?
drug is added to and eliminated from a central compartment (plasma and high perfused tissues such as liver and kidney)
What is a two compartment system mammillary model?
central compartment (can have anatomic/physiological compartment with alot of blood flow) plus tissue compartment (not alot of blood flow)
What is a catenary model?
type of compartment model

multiple tissue compartments connected to each other and the central compartment like a train

all compartments are not directly linked to central compartment
What do physiological and compartmental models have in common?
pathophysiological conditions influence data and therefore the model