Lecture 1 1/23/24 Flashcards
What constitutes a drug product?
the active and inactive components
What is a drug?
any substance that brings about a change in biologic function through its chemical action
What is a receptor?
a specific molecule that a drug molecule interacts with
What are the potential ways to identify a specific drug?
-chemical name
-chemical abstracts registry number
-generic name
-trade name
Which agencies are involved in the regulation of animal drugs?
-FDA
-USDA
-EPA
-state pharmacy boards
-state veterinary boards
Which products are regulated by the FDA?
-human and veterinary drugs
-biological products
-medical devices
-food supply
-cosmetics
-radiation-emitting products
What is the role of the USDA and APHIS?
-regulate veterinary biologics
-regulate drug residues in edible animal tissues
Which products are regulated by the EPA?
-topically applied parasiticides
-animal facility insecticides/parasiticides
What are the steps of drug approval?
-begins with a sponsor that collects and submits all info about a drug
-NADA process to ensure drug safety, efficacy, and potential adverse environmental effects
-presentation of NADA to FDA; drug can be sold if approved
What are the 5 major sections of the NADA?
-target animal safety
-effectiveness
-human food safety
-chemistry, manufacturing, and controls
-environmental impact
What are the 2 minor sections of the NADA?
-all other information
-labelling
Who determines if a drug is safe for over-the-counter use or must be used under veterinary oversight?
FDA
What are the characteristics of an ANADA?
-abbreviated NADA application for generic drugs
-drugs must be proven to be the same as approved brand name
-bioequivalence must be proven
-generic labelling must match approved brand labelling
What is pharmacokinetics?
-study of the time course of drug absorption, distribution, metabolism, and excretion
-what the body does to the drug
What is kinetic homogeneity?
a predictable relationship between plasma drug concentration and concentration at the receptor site
What is pharmacodynamics?
-study of biochemical and physiological effects of drugs, their modes of action, and the relationship between drug concentration and effect
-how a drug behaves in the body
What is drug action?
initial consequence of drug-receptor combination
What is drug effect?
biochemical and physiological changes that occur as a consequence of drug action
What is the therapeutic window?
range of a drug’s serum concentration at which a desired effect occurs
How is the therapeutic index calculated?
dividing 50% value of toxicity by 50% value of efficacy
How does therapeutic index relate to drug safety?
the wider the therapeutic index, the safer the drug
What values are most important to determine when conducting therapeutic drug monitoring?
-peak: maximum drug efficacy
-trough/low: when to give next dose as to not cause toxicity
What is therapeutic drug monitoring?
-use of assay procedures to determine drug concentrations in plasma
-interpretation of assays to develop safe and effective drug regimens
What are the criteria for conducting therapeutic drug monitoring?
-narrow therapeutic window
-variable pharmacokinetics
-correlation between concentration and efficacy
-no alternative therapies
