TERM 1
What is the goal of prefomulation studies?
DEFINITION 1
To determine the physical-chemical characteristics of the
drug
TERM 2
Adjustments in the preformulation are done to
change therapeutic efficacy. T/F
DEFINITION 2
Falseadjustments are made that only change the physical
chemical properties. Therapeutic efficacy remains the same.
TERM 3
preformulation studies determine the kinetic
rate profile T/F
DEFINITION 3
Yes kinetic rate profile is also known as stability.
Preformulation studies will determine this
TERM 4
T/F Production of the drug is done prior to
initial toxicity studies and analytical work
DEFINITION 4
FalseA sufficient quantity of a compound is synthesized to
perform-intial toxicity -analytical work -intitial preformulation
workbut production doesn't start until the Approval of an
NDAPhase I--> Phase II---> Phase 3 --> NDA submitted --->
NDA approved ---> production
TERM 5
T/F Formulation and stability difficulties arise
less frequently in liquid preparations
DEFINITION 5
FalseSolids are less likely to have difficulties with formulation
and stability
