Introduction to Biopharmaceutics Flashcards
What is bioavailability?
fraction of drug that reaches the systemic circulation
What does pharmacokinetics study?
The movement of a drug through the body over time, encompassing absorption, distribution, metabolism, and excretion (ADME)
Pharmacokinetics answers the question: What does the body do to the drug?
What does pharmacodynamics involve?
The study of the biological and physiological effects of drugs on the body and their mechanisms of action
It answers the question: What does the drug do to the body?
What is pharmacogenetics?
The study of how genetic variations influence an individual’s response to drugs
It focuses on inherited differences in genes affecting drug-metabolizing enzymes, transporters, and receptors.
What is the focus of toxicology?
The adverse effects of chemicals, including drugs, on living organisms
It examines mechanisms, symptoms, detection, treatments of toxic exposures, and safe levels of usage.
Define biopharmaceutics.
the study of the relationships between the physical and chemical properties, and its activity in the living body.
It aims to optimize drug delivery systems for maximum therapeutic benefit.
What are drugs?
Chemical substances or biological agents used to diagnose, treat, prevent, or alleviate diseases and medical conditions
Drugs can be derived from natural sources, synthesized chemically, or produced biotechnologically.
What is a dosage form?
The physical form in which a drug is delivered to the body to achieve the desired therapeutic effect
Examples include tablets, capsules, injections, creams, and solutions.
What does drug product performance refer to?
How well a drug product delivers its active ingredient to achieve the intended therapeutic effect
It involves assessing drug release rate, absorption, and bioavailability.
Fill in the blank: Pharmacokinetics encompasses the processes of _______.
absorption, distribution, metabolism, and excretion (ADME)
True or False: Pharmacodynamics answers the question, ‘What does the body do to the drug?’
False
Describe the bioavailability of Intravenous route of administration.
IV
100 % bioavailability.
pros: most rapid onset
Describe the bioavailability of Intramuscular route of administration.
IM
75 - 100 % bioavailability
pros: can use large volumes
cons: painful
Describe the bioavailability of subcutaneous route of administration.
SC
75 - 100 % bioavailability
cons: painful
smaller volume than IM
Describe the bioavailability of oral route of administration.
PO
5 - less than 100 % bioavailability
pros: most convenient
cons: first pass effect
Describe the bioavailability of rectal route of administration.
PR
30 - less than 100 % bioavailability
pros: less first pass effect than oral
Describe the bioavailability of inhalation route of administration.
5 - less than 100 % bioavailability
pros: very rapid onset
Describe the bioavailability of transdermal route of administration.
80 - 100 % bioavailability
pros: no first pass effect
prolonged duration of action
cons: slow absorption
What is Bioequivalence?
Compares bioavailability study of two or more formulations of the same drug.
Explain the dose effect relationship with PK and PD?
When a dose of a drug is administered, a conc. of the drug enters systemic circulation.
3 things can occur next:
1. there is a concentration of drug at the site.
2. drug is metabolised and excreted.
3. drug is distributed to tissues
This first part is PK
Next at the site a pharmacologic effect occurs for a clinical response ( toxic or therapeutic)
this second part is PD
Physiological vs Pathological
Physiological: refers to the body
Pathological: refers to a disease/ condition
Explain the biopharmaceutics behind a drug excreted renally and a patients with impaired kidney function.
excretion is affected when compared to a patient with a healthy kindey.
However they still need the drug so you must optimize the therapeutic benefit of the drug to prevent SE
extravascular vs intravascular administration
Extravascular: outside the vein
with extravascular drug must first be absorbed, transported to
site of action to acquire
biological/therapeutic outcome
intravascular: within the vein
in vivo vs in vitro
in vivo: in the body (clinical trials)
in vitro: in the lab
The extent of absorption is measured by the area under the curve
True or False
True
Dose effect can be therapeutic or toxic.
True or False
True