Introduction Flashcards
It is to formulate, manufacture, use, dispense, determine, stability, effectivity and safety or a drug formulation
Pharmaceutics
Study of factors that influence BIOAVAILABILITY of a drug.
Biopharmaceutics
Use of biopharmaceutics
For OPTIMUM PHARMACOLOGIC or THERAPEUTIC ACTIVITY of drug products.
RATE or EXTENT of systemic absorption of the active drug.
Bioavailability
Determines the FATE OF SUBSTANCES administered in a living organism
Pharmacokinetics
What does Pharmacokinetics ask
What the body does to the drug?
It studies the action of drugs in TARGET ORGANS
Pharmacodynamics
Pharmacodynamics include
Mechanisms of drug action
Relationship between drug concentration and effect
How GENETIC VARIATIONS affect drug response
Pharmacogenetics
Study of the DIFFERENT FORMULATIONS with comparable bioavailability when studied at similar conditions.
Bioequivalence
Adjustable factors of Pharmacokinetics include
Dose
Dosage form
Route of administration
Drug concentration vs. time
Body’s response to drug exposure
Pharmacodynamics rely on
Variabilities
It is the DRUG TOWARDS TIME
Area under the curve
Quantitative basis of drug therapy
Amount of dose administered (How much)
Frequency of administration (How often)
Duration of treatment (For how long)
What level produces SUFFERING?
Toxic level
A level where the DRUG TAKE EFFECT in a certain time or concentration
Therapeutic window or range
The level where the drug did NOT PROVIDE therapeutic effects
Subtherapeutic level/ineffective therapy
APPLICATION of pharmacokinetic methods to drug therapy in PATIENT CARE
Clinical Pharmacokinetics
Clinical Pharmacokinetics involved MULTI-DISCIPLINARY APPROACH to individually optimized dosing strategies based on
Patients diseased state
Patient-specific considerations
ORGANS that have a VITAL ROLE in Pharmacokinetics
Liver
Kidney
What race makes ARBs NON EFFECTIVE
African-American
Application of Clinical Pharmacokinetics
Therapeutic drug monitoring
What does TDM monitors
Plasma drug concentration
Pharmacodynamic endpoints
It is the CONCENTRATION of drug within the BLOOD
Plasma drug concentration
TDM is usually CONDUCTED for
Very potent drugs/narrow therapeutic range
It is OUT of the MAXIMAL DOSE
Potent
Example of potent drugs
Digoxin-Cardiac glycoside
RELEASE of the active ingredient
Liberation
In liberation, the RATE of drug release from a dosage form would highly DEPEND on
Dosage form
When the amount of active ingredient reaches the SYSTEMIC CIRCULATION
Absorption
TRANSFER of active ingredients from the site of absorption to the site of action
Distribution
Use of receptors
For the drug to take effect
CHEMICAL TRANSFORMATION of a drug to it’s metabolite to be ready for excretion
Metabolism
REMOVAL of metabolites
Excretion
Most drugs are excreted by the __________ in the form of __________
Kidneys
Urine
Other drugs maybe removed from the body through
Sweat
Saliva
Exhaled air
Feces
EFFECT brought about by the drug to the patient
Response
Factors of a drug response
Drug formulation (Pharmaceutics)
Drugs inert activity (Pharmacology)
Genetic makeup (Pharmacogenetics)
Biopharmaceutics is a field of science that examines the INTERRELATIONSHIP of the
Physicochemical property
Dosage form
Route of administration
What clinical testing involves the STABILITY of the drug, toxicity effects and does not exceed therapeutic window.
Animal testing
What clinical testing focuses on the SAFETY, have SMALLER and SIMILAR characteristics of respondents.
Upon the increase or decrease of dose would provide toxic effects.
Phase 1
What clinical trial focuses on SAFETY and EFFICACY.
LARGER population
NO STAGING
Phase 2
Clinical trial with diversified COMORBIDITIES
Phase 3
Clinical trial where drugs are already RELEASED in the MARKET
Monitor, efficacy, toxicity, ADR
Post - marketing surveillance
Phase 4
