MODULE 1 Flashcards
Intended for diagnosis, cure, mitigation, treatment, or prevention of disease
Drug
Give the Dosage Forms:
Solid (tablet, capsule)
Semisolid (ointment, creams)
Liquids
Suspension
Emulsion
Considered as drug delivery system as it release and deliver drugs to site of action
Drug products
Designed to meet patient needs such as Palatability, Convenience, and Safety
Drug products
Examines the interrelationships of physical/chemical properties of drug
Biopharmaceutics
Rate and extent of drug absorption
Bioavailability
Measures the availability of the drug
Bioavailability
Described as the sequence of events that precedes elicitation of drugs therapeutic effect
Drug substance and Drug formulation
Drug is released from dosage form
Liberation
Where drug reached the site of action
Distribution
Results when site of action reaches or exceeds the minimum effective concentration
Pharmacodynamic response
Tiniest amount of drug that produce a pharmacologic effect
MEC
It is where the Starting dose, Maintenance dose, Dosage form, and Dosing intervals are determined
Clinical trials
Provides a scientific basis on product design and product development
Biopharmaceutics
Most important steps in manufacturing process is termed what?
Critical manufacturing variable
It involves Test apparatus and equipments and no involvement of Laboratory animals or humans.
In vitro methods
It involves humans and laboratory animals
In vivo methods
Science of kinetics of drug absorption, distribution and elimination.
Pharmacokinetics
Description of drug distribution and elimination is often termed as what?
Drug disposition
Pharmacokinetics involves 2 approaches/aspects. What are these?
Experimental aspect
Theoretical aspect
Involves development of biologic sampling techniques, analytical methods for the measurement of drugs and metabolites
Experimental aspect
Involves development of pharmacokinetics models that predicts drug disposition
Theoretical aspects
Integral part of pharmacokinetic studies
Statistics
Used for pharmacokinetic parameter estimation and data interpretation
Statistical methods
FDA approved label
Package insert
Drug concentration below MEC
Subtherapeutic
Drug concentration above the MTC
Toxic response
It involves multidisciplinary approach
Clinical pharmacokinetics
Study of pharmacokinetic differences of drugs in various population
Population pharmacokinetics
True or False
Clinical pharmacokinetics is also applied to Therapeutic drug monitoring.
True
Example of Prothrombin clotting time
WARFARIN / PLDTWG
Drugs that are frequently monitored
Aminoglycosides
Anticonvulsants
Drugs that are closely monitored
Cancer chemotherapy
Study of drug effect including distribution and disposition due to genetic differences. Is also the main reason why many new drugs have to be further studied
Pharmacogenetics
Related field which emphasizes different aspects of genetic effect on drug response.
Pharmacogenomic
Its measurements can confirm whether the drug dose is subtherapeutic or was not responsive to the drug therapy
Plasma drug concentration
Study of the biochemical and physiological effects of drugs on body.
Pharmacodynamic
Molecules that interacts with specific drugs to produce pharmacologic effect on body
Receptors
Refers to the relationship between drug concentration and pharmacologic response.
Pharmacodynamic
Refers to the dose (drug input to the body) and various measures of acute or integrated drug conc. & other biological fluids (Cmax, Cmin, Css)
Drug exposure
Refers to direct measure of the pharmacologic effect of drug.
Drug response
Provides information on safety and effectiveness of drug during development .
Toxicologic and Efficacy studies
Application of pharmacokinetic principles to design, conduct, and interpretation of drug safety.
Toxicokinetics
Aids in the interpretation of toxicologic findings in animals and extrapolation of resulting data to humans.
Toxicokinetic data
Performed in animals during preclinical drug development.
Toxicokinetic studies
Study of adverse effects of drugs and toxic substances such as poisons in body.
Clinical Toxicology
Drugs frequently involved in toxicity cases includes:
Acetaminophen
Salicylate
Opiates
TCAs
Causes an increase in heart rate when given intravenously but has no observable effects on the heart when given orally.
Isoproterenol
May differ from one drug to another containing the same drug, even the same route of administration.
Bioavailability
Provides a scientific basis for drug design and drug development.
Biopharmaceutics
May affect the drug product performance including the release of drug from drug product.
Excipient
Science of kinetics of Drug absorption, distribution, and elimination - ( metabolism and excretion)
Pharmacokinetics
The most important steps of the manufacturing process are termed what?
Critical manufacturing variable
Main reason why many drugs still have to be further studied after regulatory approval.
Pharmacogenetics
Is it desirable that this occurs at drug concentration higher relative to the therapeutic drug concentrations
Adverse drug reaction
Oral
Mouth
Sublingual
Under the tongue
Parenteral
By injection
Intraosseous
Bone
Intra-articular
Joint
Intrasynovial
Joint fluid area
Aural
Ear
