veterinary drug development and control

what are the four major steps in drug development?

1. synthesis/discovery of a new drug compound

2. safety/effectiveness evaluation

3. submission and review of the New Animal Drug Application (NADA)

4. postmarketing surveillance stage—- techs most “role” we play in

effective dose (ED50):

the amount of the test drug that causes a defined effect in 50% of the animals that receive it

Lethal dose (LD50):

the amount of the test drug that kills 50% of the animals that receive it (generally tested on rats/mice and rabbits)

therapeutic index:

the drug dosage or dose that produces the desired effect with minimal or no signs of toxicity

another name for therapeutic index:

margin of safety

how is the therapeutic index determined?

by comparing the lethal dose and effective dose of the drug (LD50 divided by ED50)

what does having a wide therapeutic index mean?

that the drug can produce its desired effect without approaching toxicity

what tests do new drugs go through?

systems-oriented screening (CBC, chem, etc), evaluation of long-term effects, evaluation of reproductive effects- we don’t have a lot to compare with humans since our repro tracts and gestations are different, carcinogenicity (risk at which the drug gives for cancer), and teratogenicity (abnormal formation of fetus risk to the drug)

direct marketing:

drug is purchased directly from the company that makes it

distributors or wholesalers (sales rep):

drug is purchased from the manufacturing company and resold to veterinarians (the people who come to clinics to sell you their products)

generic companies:

sell drugs that are no longer under patent protection (for example, cerenia= maropitant, comfortrate= maropitant, etc)