Module 1 Drug Development Flashcards
What three characteristics define a disease?
- recognition of where it came from (genetic or environmental)
- identifiable signs and symptoms
- consistent anatomical alterations
What is a drug?
Agent used in diagnosis, treatment, and cure or prevention of a disease
What is a poison?
What a drug is known as when it is given to a healthy person
What is a lead compound?
The prototype compound that produces the desired effect in the patient
What is a prodrug?
Alters the lead compound to require metabolic biotransformation before it is active in the body
What is the purpose of a prodrug?
- Increases stability
- Increases solubility
- Drug targeting
- Sustained release
- Reduces toxicity
- Increases absorption
What is a dosage form?
The way the drug is presented and administered to the patient
Types of dosage forms
- Solid (tablet, capsule, powder, lozenge)
- Liquid (solutions, dispersions, sterile products)
- Semi-solid (ointments, creams, lotions, gels, etc.)
- Other (aerosols, transdermal patches, inserts, sponges)
What are excipients?
The inactive ingredients required to make a dosage form
Why provide different dosage forms?
- safe and convenient administration
- protect against chemical decomposition (internal and external)
- conceal odors or tastes
- control release in body
What is a formulation?
The list of ingredients of a dosage form (includes medical and excipients)
What factors are considered in a formulation?
- drug-physical and chemical properties of the drug substance
- therapeutic-the disease and patient factors
- biopharmaceutic- absorption of drug through different routes of administration
What is a dose?
The amount of the drug given (while being safe and effective)
Dosage Regimen
Drug + Dose + dosage interval + length of therapy
What you are giving + how much + how often + for how long
What is a drug product?
The specific preparation or formulation of the drug
Components of a drug product
- active ingredient
- excipients
- dosage form
- method of preparation
Proprietary (brand) name
The trademark name for a drug registered by the company
eg. Tylenol
Non-proprietary (generic) name
generally recognized or “common” name for a drug
eg. acetaminophen
Routes of Administration
Sublingual (under tongue) Inhalation Oral Transdermal Patch Rectal Topical Parenteral (IV)
What determines the route of administration?
- Disease or condition being treated
- Condition of patient
- Age of patient
- Physical and chemical properties of the drug
What are pharmaceutics?
Concerned with:
- formulation
- manufacture
- stability
- effectiveness
What are biopharmaceutics?
Studies the properties of the drug and dosage form after administration
What are pharmacokinetics?
Study of what the body does to the drug
What are pharmacodynamics?
Study of what the drug does to the body
What does ADME stand for?
Absorption
Distribution
Metabolism
Excretion
What is a disease?
A condition that interferes with an organism’s normal state
