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level: Level 1

Questions and Answers List

level questions: Level 1

Question	Answer
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	Biopharmaceutics
it includes the color, density, hardness, and melting and boiling points.	Physical properties
describes its "potential" to undergo some chemical change or reaction by virtue of its composition.	Chemical properties
produces blood levels similar to those produced by intramuscularly administered sodium ampicillin or ampicillin trihydrate	Oral amoxicillin
are substances intended for use on the diagnosis, cure, mitigation, treatment, or prevention of disease… given in a variety of dosage forms or drug products…for systemic or local activity.	Drugs
defined as the release of the drug substance from the drug product either for local drug action or for drug absorption into the plasma for systemic therapeutic activity. (Disposition)	Drug Product Performance
Bioavailability may be measured based on selected __ measurements to reflect the rate and extent to which __ becomes available to employ its desired therapeutic effect at the intended site of action.	PK (pharmacokinetic), API (Active Pharmaceutical Ingredient)
is the study of the biochemical and physiologic aspects of drug effects.	Pharmacology
Fate of the drug:	Liberation Absorption Distribution Metabolism Elimination Response/Reuptake Toxicity
1 refers to how the body handles absorption,distribution, biotransformation(metabolism) and excretion “what the body does to the drug”, How the drug moves. ADME. Diffusion (Passive,active) 2 (Response) refers to the study of the biochemical and physiologic effects of drugs and their mechanism of action in the body “what the drug does to the body”, How the drug behaves. (Beneficial, toxic)	1 Pharmacokinetics 2 Pharmacodynamics
The description of drug distribution and elimination is often termed	drug disposition
is the MODALITY of drug administration that is chosen to reach the therapeutic objective. This depends on the drug used, the condition to be treated, and the patient’s characteristics. Characterization of drug disposition is an important prerequisite for determination or modification of __ for individuals and group of patients.	dosing regimens
1 deals with the principles of preparing and compounding medicines in order to optimize their absorption 2 is the amount of a medication administered to a patient in a single dose	1 Galenic formulation 2 Unit dose
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
It is the study of the biochemical and physiological effects of drugs on the body; this includes the: 1 Mechanism of action 2 Relationship between drug concentration and effect A typical example of this is how a drug interacts quantitatively with a drug receptor to produce a response (effect)	pharmacodynamics
The __, (the pharmacologic effect), can be therapeutic and/or cause toxicity. For many drugs, the __ is dose/drug concentration related; the higher the dose, the higher drug concentrations in the body and the more intense __ up to a maximum effect It is desirable that S/E and/or toxicity of drugs occurs at higher drug concentrations than the drug concentrations needed for the therapeutic effect. Unfortunately, unwanted S/E often occur concurrently with the therapeutic doses.	Pharmacodynamic effect
The fraction (or percentage) of the administered dose of drug that reaches the systemic circulation	Bioavailability
API + PA (excipients) will affect __	the final drug product’s performance