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can be defined as the study of the physical and chemical properties of drugs and their proper dosage as it relate to the onset, duration, and intensity of drug action, or it can be defined as the study of the effects of physicochemical properties of the drug and the drug product. examines the interrelationship of the physical/chemical properties of the drug the dosage form (drug product) in which the drug is given and the route of administration on the rate and extent of systemic drug absorption. It is based on fundamental scientific principles and experimental methodology. Use both In-vitro & In-vivo methods


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136 questions
Fate of the drug:
Liberation Absorption Distribution Metabolism Elimination Response/Reuptake Toxicity
The study of pharmacokinetics involve these approaches:
1 Experimental approach 2 Theoretical approach
1 Experimental Approach vs 2 Theoretical Approach
1 Development of biologic sampling techniques Analytical methods for the measurement of drugs and metabolites Procedures that facilitate data collection and manipulation 2 Development of pharmacokinetic models that predict drug disposition after drug administration (math and computer techniques are heavily utilized)
Differentiate In Vitro from In Vivo studies
An in vitro study occurs in a controlled environment, such as a test tube or petri dish. In In Vivo, It refers to tests, experiments, and procedures that researchers perform in or on a whole living organism, such as a person, laboratory animal, or plant.
In vivo is Latin for
“within the living.”
Biopharmaceutics involves factors that influence
The design of the drug product Stability of the drug within the drug product The manufacture of the drug product The release of the drug from the drug product The rate of dissolution/release of the drug at the absorption site Delivery of drug to the site of action
API + PA (excipients) will affect __
The final drug product’s performance
In Pk, Some drugs frequently monitored:
1 aminoglycosides (kidney injury, hearing impairment and vestibular toxicity) 2 anticonvulsants,(phenytoin) 3 cancer chemotherapy drugs
Sampling of biologic specimens METHODS
1 Invasive methods - Blood - Spinal fluid - Synovial fluid - Tissue biopsy, or any biologic material that requires parenteral of surgical intervention in the patient 2 Non-invasive methods - Urine - Saliva - Feces - Expired air - Or any biologic material that can be obtained without parenteral or surgical intervention
It is the most direct approach to assessing the Pk of the drug in the body
Measurement of drug and metabolite concentrations (levels) in the Blood Serum, or Plasma
1 Obtained by venous puncture and contains anticoagulant such as heparin or EDTA 2 Component:
1 Whole blood 2 All the cellular and protein elements of blood
1 The liquid obtained from whole blood after it is allowed to clot and the clot is removed 2 Component:
1 Serum 2 Does not contain cellular elements, fibrinogen, or the other clotting factors from the blood
1 The liquid supernatant obtained after centrifugation of non-clotted whole blood that contains an anticoagulant 2 Component:
1 Plasma 2 It is the noncellular liquid fraction of whole blood and contains all the proteins including albumin
Plasma vs Serum
1 Plasma is the liquid, cell-free part of blood that has been treated with ANTI-COAGULANTS 2 Serum is the liquid part of the blood AFTER COAGULATION, therefore devoid of clotting factors as fibrinogen
Why are drug concentrations more often measured in plasma rather than whole blood or serum?
It is the most direct approach to assess the pk of drug in the body PLASMA perfuses all the tissues of the body, including the cellular elements in the blood Small molecules in the blood are carried thru the plasma Changes in the drug concentration in plasma will reflect changes in tissue drug concentrations. Measuring the plasma drug level is a responsive method of monitoring the course of therapy.
What is the relationship of drug concentrations to drug response?
The measurement of drug concentrations confirms effect of the drug dose
Drug in blood exists in two forms:
Bound and unbound. A drug's efficiency may be affected by the degree to which it binds to the proteins within blood plasma. The less bound a drug is, the more efficiently it can traverse cell membranes or diffuse.
1 Common blood proteins that drugs bind to are: 2 Act as transporters
1 human serum albumin, lipoprotein, glycoprotein, and α, β‚ and γ globulins. 2 enzyme, proteins etc
What is the differences between the concentrations in the plasma of? 1 Bound drug 2 Unbound drug
. 1 Take too long to effect and may accumulate and cause toxicity 2 Gives therapeutic effect
Benzodiazepines duration in: 1 Urine 2 Oral Fluid 3 Hair
. 1) 1-14 days 2) 0-36 hours 3) 7 - 90 days
What is the Importance of Monitoring the plasma drug concentrations?
1 Compliance monitoring 2 Individualizing therapy – during early therapy and during dosage changes 3 Diagnosing under-treatment 4 Avoiding toxicity 5 Monitoring and detecting drug interactions 6 Guiding withdrawal of therapy - allow for the adjustment of the drug dosage - to individualize and optimize therapeutic drug regimens. - When there is alterations in physiologic functions, monitoring may provide a guide to the progress of the disease state - enable the investigator to modify the drug dosage accordingly.
API + PA (excipients) will affect __
The final drug product’s performance
Rate constants TWO PARAMETERS
1 Fluid Volume that will dilute the drug (v) 2 Elimination rate of drug (k) per unit of time
Why use Pharmacokinetic models?
1 To stimulate the RATE PROCESS of drug ADME to predict drug concentration in the body 2 Predict plasma, tissue, and urine drug level with any dosage regimen 3 Calculate the optimum dosage regimen for each patient individually 4 Estimate the possible accumulation of drugs and metabolites 5 Correlate drug concentration with pharmacologic or toxicologic activity 6 Evaluate differences in the rate or extent of availability between formulations (bioequivalence) 7 describe how changes in physiology or disease affect the absorption, distribution or elimination of the drug 8 explain drug interaction
Rate constants TWO PARAMETERS
1 Fluid Volume that will dilute the drug (v) 2 Elimination rate of drug (k) per unit of time
Types of Pharmacologic Models
1 Empirical Models 2 Physiologically based models 3 Compartment models
Compartment models TYPES
1 Caternary models 2 Mamillary models 3 Physiologic Pk models
Rate constants TWO PARAMETERS
1 Fluid Volume that will dilute the drug (v) 2 Elimination rate of drug (k) per unit of time