role of clinical pharmacology in drug development. Clinical trials – phases, designs in clinical research.

Question 1

what is DRUG SCREENING

Answer 1

repeated experimentation of a drug candidate m.cule

tests depend on end goal

Question 2

types of preclinical PHARMACODYNAMIC research

Answer 2

in vivo: antiinflamm drugs

in vitro; ANAGELSIA

Question 3

preclinical safety factors to consider

Answer 3

gene toxicity

carcinogenity

reproductive toxicity

etc

Question 4

define a clinical trial

Answer 4

evaluation of new drugs in human beings

Question 5

variable factors in clinical trials

Answer 5

SUBJECT AND OBSERVER BIAS

concomitant disease presence

variability in progression of diseases

Question 6

methods to avoid subject and observer bias

Answer 6

use of a placebo

Question 7

define placebo

Answer 7

inert material, with identical physical appearance, odor, consistency, etc, as the active dosage form.

Question 8

define nocebo

Answer 8

adverse effects from a placebo drug

Question 9

explain placebo trial

Answer 9

split pt into two

give one half placebo

diff in response shows

drug effectiveness
comparison is rx standard so an already effective drug shouldnt be used

Question 10

single blind

Answer 10

pt is undaware of rx

Question 11

double

Answer 11

both doc and pt are unaware of rx

masked or double ddummy

Question 12

masked

Answer 12

One investigator dispatches the medication, another investigator performs the assessments

Question 13

Double-dummy design

Answer 13

if it’s impossilbe to blind

e.g. comparing effectivness of tablet vs injection

Question 14

purpose of randomisation

Answer 14

to even out unknown factors that could cause bias are cancelled out

Question 15

avoiding natural history of disease

Answer 15

evaluation of large population sample

preventing errors of interpretation using crossover trial

Question 16

describe cross over trial

Answer 16

initial drug and placebo prescription

washout period

swap the prescription of placebo and drug

Question 17

types of clinical trial design type

Answer 17

open and closed

Question 18

describe open trials

Answer 18

descriptive

lack control groups

inconclusive

can be used in phase 1 and special cases

Question 19

controlled trials

Answer 19

conrolled

randomised

use placebos

Question 20

drug phases

Answer 20

phase 1: open 
first human app
phase 2 controlled
first app to pts
phase 3 controlled 
efficacy and safety 
phase 4 post markerting surveillance

Question 21

phase 1

Answer 21

10-15

assess safety and tolerability

small no of ppl

determine pharmacokinetics and pharmacodynamics

healthy volunteers

progressive escalation of osingle doses until ADR occurs

Question 22

phase 2

Answer 22

100-150 ppl

assess safety and tolerability w/ different doses

asess optimal dose and pharm formlation

uses controlled methods and romdomisation

Question 23

phase 3

Answer 23

500-3000 ppl

confirms efficacy and safety

asses efficacy on a large scale

asses benefit to risk ration

asses drug interaction

if succesful may appl y for licensing

Question 24

phase 4

Answer 24

therapeutic use

confirms benefit-risk ration

ID of rare ADR