Chapter 2 Lec

Question 0

Differentiate the effect and potency of the test agent from those of control

Answer 0

Bioassaya

Question 1

Ability of cells w the potential to produce a desired antibody

Answer 1

Monoclonal antibody

Question 2

Body’s means of transforming nonpolar molecules to polar compounds

Answer 2

Biochemical transformation

Question 6

Useful in treatment of diabetes mellitus

Also has anti tumor capabilities

Answer 6

Periwinkle or vinca rosea

Question 7

Chemical alteration

Answer 7

Molecular modification

Question 8

Basic techniques that has the ability to manipulate and produce proteins

Answer 8

Recombinant DNA and monoclonal antibody

Question 9

Has the potential to produce any protein

Genetic material can be transplanted from higher species to a lowly bacteriun

Answer 9

Recombinant dna

Question 10

Medical intervention based on the modification of the genetic material

Answer 10

Human gene therapy

Question 11

Molecular modification to design a drig that interferes with the known biochemical pathway

Answer 11

Mechanism based drug design

Question 12

Produce the specifically desired effect

No side effects

Answer 12

Goal drug

Question 13

Undertaken to reveal any effect of an active ingredient on mammalian reprod

Answer 13

Reproduction studies

Question 14

Clinical trial materials

Answer 14

New drug, placebo and the drug product which the new prof is to be compared

Question 15

Prototype chemical compound that had a fundamental desired biologic or pharmacologic activity

Answer 15

Lead compound

Question 16

Involves testingg of large numbers of synthetic organic compounds

Answer 16

Random or un targeted screening

Question 18

A compound that requires metabolic biotransformatiin after administration to produce the desired pharmacologically active compound

Answer 18

Prodrug

Question 19

Allows vets to prescribe extra label uses or animal drugs and human drugs for animals

Answer 19

Animal medicinal drug use of clarification act of 1994

Question 20

2 animal species for drug metabolism

Answer 20

Rodent and dog

Question 21

Special care of the prescriber and patient in the use of the drug

Answer 21

Precautions

Question 22

First pass effect

Answer 22

Drugs thru liver and exposure to hepatic enzymes

Question 23

45% sucess

Answer 23

Phase 2

Question 25

20-100 subjects

Answer 25

Phase I- healthy subjects

Question 27

Controlled in which atleast one of the parties does not know which producy is being administered

Answer 27

Blind studies

Question 30

Quantitative range or amount of drug that may be prescribed safely

Answer 30

Usual dosage rangr

Question 32

2 weeks at 3 dosage lvls to 2 animals

Answer 32

Subacute or subchronic studies

Question 33

Used to gather supplemental info that may contain support certain labeling requests

Answer 33

Phase 3b studied

Question 34

To test if the comp can affect gene mutation

Answer 34

Genotoxicity

Question 35

Speed at which a drug substance dissolves in a medium

Answer 35

Dissolution rate

Question 36

Undertake when the comp has shown sufficient promise as a drug to enter human clinical trials Carried out in rats and mouse strains 18-24 months

Answer 36

Carcinogenic studies

Question 37

Orphan drug act of 1983

Answer 37

Rare diseases that affects lower than 200,000 people

Question 38

Objective is to make promising drugs available to desperately ill patients

Answer 38

Treatment IND

Question 40

67% success

Answer 40

Phase I

Question 41

Controlled clinical studied to evaluate effectiveness of a drug in patients with the condition for which the drug is intended for

Answer 41

Phase 2- unhealthy subjects

Question 43

100-1000 patients Last for 1-4 trs Safety effectiveness and sosge 5-10%

Answer 43

Phase 3

Question 44

Fda approved indication prevention or diagnosis

Answer 44

Indication and usage

Question 45

May influence a drugs action by altering its pharmacokinetic profile

Answer 45

Genetic polymorphism

Question 46

Amount that is enough to achieve the drugs optimum therapeutic effect

Answer 46

Dose of drug

Question 47

Nonclinical lab studied may be omitted | Duplicates or generic copies

Answer 47

Abbreviated new drug application

Question 48

Predictable and unpredictable undesired effects

Answer 48

Adverse rxns

Question 49

Descriptjon of the adverse reactions and safety hazards

Answer 49

Warnings

Question 50

Summary of all actions of drugs

Answer 50

Clinical pharmacology

Question 51

A tranquilizer and a hypotensive agent

Answer 51

Reserpine

Question 52

First human gene therapy

Answer 52

Adenosine deaminase deficiency

Question 53

Risk of use clearly outweighs any beneficial effecy

Answer 53

Contraindication

Question 55

Biochemical transformation results in..?

Answer 55

Production of metabolites

Question 59

Ability to endure the influence of the drug

Answer 59

Tolerance

Question 60

Rectal buccal administration

Answer 60

Drugs are absorbed into the systemic circularion through blood vessels

Question 62

Initial intro | Purpose of assessing safety

Answer 62

Phase I - healthy subjects

Question 66

deals w the adverse or undesired effects of drugs

Answer 66

Toxicology

Question 69

Capable of examining 15,000 chem compounds a week using 10-20 biologic assays

Answer 69

High throughout screening

Question 76

Determine the toxic effects over a short period of time

Answer 76

Acute toxicity studies