6.4 Intro Pharmacology Flashcards
Define Pharmaceutics
-Deals with dosage form design
Example Nicotine dosage forms, the drug is commercially available as the base in transdermal systems, and oral inhaler, a nasal solution and the polacrilex in chewing gum.
Define Pharmacokinetics
“What the body does to drugs” The study of the absorption, distribution, metabolism, and execration of drugs from the body.
Define Pharmacodynamics
“What drugs do to the body”. The study of the relationship between concentrations of drug and the biologic effects (physiological or biochemical) over time.
What is nicotine?
it is a ganglionic nicotinic cholinergic receptor agonist.
What are some examples of drugs made from nature?
Antibiotics, foxglove, opium, hela monster spit for diabetas, and tick saliva for anticoagulant.
What are the steps for FDA approval?
Phase 1: Establish safety (Healthy Volunteers)
Phase 2: Establish efficacy and dose (small # of patients)
Phase 3: Verify efficacy and detect adverse affects (large number of patients)
Phase 4: Obtain additional data following approval, and use in the real world
How long does it take a drug to go from discovery to market shelves?
20 years on average
Define Over the counter
1) Drugs that do not require a doctors prescription
2) Bought off-the-shelf in stores
- The FDA regulates through OTC drug monographs that covers acceptable ingredients, doses, formulations and labeling. Constantly updated
Define Prescription Drugs
1) Prescribed by a doctor
2) Bought at pharmacy
3) Prescribed for and intended to be used by one person.
- Regulated by New Drug Application process.
Define a drugs Chemical Name
Is given when novel chemical entity or biological developed. The chemical name is a scientific name based on the compound’s chemical structure and is almost never used to identify the drug in a clinical or marketing situation.
Define a drugs Generic Name
Is commonly used to identify a drug during its useful clinical lifetime. It is also known as its international Non-proproetary Name or INN. INNs facilitate the identification of pharmaceutical substance or active pharmaceutical ingredients. Each IN is a unique name that is globally recognized and is public property. An INN is designated by the World Health Organization.
Define a drugs Trade Name
The company the patents a drug usually also create its brand name, thus that company has exclusive rights to use it. A drug can have more than one trade name.
Define Pharmacology
The science that is concerned with understanding the interactions of chemical substances with living systems, and the application of this understanding to the treatment of patients.
Define Drug
A substance that acts, often by interaction with regulatory molecules, to stimulate or inhibit normal physiologic/biological processes.
What does the FDA require if there is a severe danger due to the drug?
The black box warning
