Quiz 7 Drug Devt II Flashcards
According to the Roche video on target identification, there are several approaches to finding a candidate drug target. What is not one of Roche approach?
Identifying what enzyme is involved in changing a drug to a less active chemical derivative
Roche video on target identification. Practically all medicine in use today interacts with a protein target by:
either inhibiting or increasing the activity of a protein target
As part of in vitro, pre-clinical research, the Ames test is performed using bacteria to determine which property of a candidate drug?
The ability of a drug to produce DNA lesions
What applies to FDA’s rules on pre-clinical testing of investigational drugs on animals?
Organs on chips are not acceptable alternatives to toxicity testing on animals
Choose the best answer. If required by FDA, in pre-clinical animal testing, the FDA would usually expect biologics to be tested in:
One small mammal and one large mammal like a dog
One type of pre-clinical research experiment is in vitro research. What does not apply to in vitro research?
Determining changes in weights of rat organs
Which is not true of Good Laboratory Practices?
Started with deaths of test animals due to excessive bleeding from warfarin
The OECD published a series of principles of Good Laboratory Practices and Compliance Monitoring. What does not apply to the OECD and the GLP principles?
OECD stands for Organization for Economic Cooperation and Divestment
The main goal of pre-clinical animal testing is to determine the ______________ to use in initial clinical trials for therapeutics in healthy human volunteers.
Maximum safe starting dose
Which of the following GLP activities is not the main responsibility of the Quality Assurance unit?
Quality assurance assigns a principal investigator for each site in multisite pre-clinical studies
What is not compliant with GLP requirements regarding facilities or operation of facilities used for animal testing?
Animals of different species should co-mingle in the same room
What is not a GLP requirement regarding equipment in animal testing laboratories?
Equipment should be the best that the company’s budget can afford
During pre-clinical research, a starting lead compound usually requires optimization of one or more of its properties. What is a property of a lead compound that researchers attempt to improve?
In some diseases, like certain cancers, broaden inhibition of multiple targets
What is not correct about the regulation of animal research under the Animal Welfare Act of 1966?
The Animal Welfare Act is enforced by Bioresearch Monitoring Office of the FDA
What applies to an animal facility that had been disqualified by the FDA for serious GLP violations?
Studies completed in the testing site may not be considered in support of application for marketing.
