m1

body of knowledge concerned with the action of chemicals on biologic systems

area of pharmacology
concerned with the use of chemicals in the
prevention, diagnosis, and treatment of disease,
especially in humans

area of pharmaclogy concerned
with the undesirable effects of chemicals on
biologic systems.

describes the effects of the
body on drugs

denotes the actions of the
drug on the body, such as mechanism of action
and therapeutic and toxic effects

Substances that act on biologic systems at the chemical (molecular) level
and alter their functions

The molecular components
of the body with which drugs
interact to bring about their
effects

The phase of drug movement
from the site of administration into the issues.

The
phase
of
drug
inactivation or removal from
the body by metabolism or
excretion.

absorption of
material
across
cell
membrane by enclosing it in
cell membrane material and
pulling it into the cell, where it
can
be
processed
or
released.

expulsion
of
material from vesicles in the
cell into the extracellular
space.

Movement of a molecule
(ex:drug) through the biologic
medium.

The actions of a drug on the
body,
including
receptor
interactions, dose-response the phenomena,
and
mechanisms of therapeutic
and toxic actions.

The actions of the body on
the drug, including absprtion,
distribution, metabolism, and
elimination. Elimination of a
drug may be achieved by
metabolism or by excretion.
Biodisposition
is
a
term
sometimes used to describe

A
specialized
molecule,
usually a protein, that carries
a drug, transmitter, or other
molecule
across
a
membrane it which it is not
permeable.
(ex:
Na/K
ATPase, serotonin reuptake
transporter, etc)

An effect on the inheritable
characteristics of a cell or
organism - a mutation in the
DNA;
usually
tested
in
microorganisms
with
the
Ames Test.

An
effect
of
inducing
malignant characteristics

An effect on the in utero
development of an organism
resulting
in
abnormal
structure or function; not
generally heritable.

An
inactive
“dummy”
medication
made
up
to
resemble
the
active
investigational formulation as
much as possible but lacking
therapeutic effect

A clinical trial in which the
investigators -but not the
subjectsknow
which
subjects are receiving active
drug and which are receiving
placebos.

A clinical trial in which neither
the
subjects
nor
the
investigators
know
which
subjects
are
receiving
placebos; the code is held by
a third party.

An
application
for
FDA
approval to carry out new
drug
trials
in
humans;
requires animal data

Seeks
FDA
approval
to
market new drug for ordinary
clinical use; requires data
from clinical trials as well as
preclinical (animal) data.

Three parts of a clinical trial
that are usually carried out
before submitting an NDA to FDa

A known standard therapy, to
be used along with the
placebo, to
evaluate the
superiority or inferiority of a
new drug in relation to the
other drugs available.

Drug developed for diseases
in
which
the
expected
number of patients is small.
Some
countries
bestow
certain
commercial
advantages on companies
that
develop
drugs
for
uncommon diseases.

most drugs have MWs between _______ and _______

in Drug-receptor Bonds what irreversible

in Drug-receptor Bonds what is cation and anion

in Drug-receptor Bonds what is hydrogen, van der
Waals, and hydrophobic bonds

it Mediates effects of drugs in the body

in Common Routes of Drug Administration what is Offers maximal convenience; absorption is
often slower. Subject to the first-pass effect,
in which a significant amount of the agent is
metabolized in the gut wall, portal circulation,
and liver before it reaches the systemic
circulation.

in Common Routes of Drug Administration what is Direct absorption into the systemic venous
circulation, bypassing the hepatic portal
circuit and first-pass metabolism.

in Common Routes of Drug Administration what is Instanteous and complete absorption (by
definition, bioavailability is 100%). Potentially
more dangerous.

in Common Routes of Drug Administration what is Often faster and more complete (higher
bioavailability) than with oral administration.
Large volumes may be given if the drug is
not too irritating. First-pass metabolism is
avoided.

in Common Routes of Drug Administration what is Slower absorption than the intramuscular
route. First-pass metabolism is avoided.

in Common Routes of Drug Administration what is The rectal route offers partial avoidance of
the first-pass effect. Larger amounts of drug
and drugs with unpleasant tastes are better
administered rectally than by the buccal or
sublingual routes.

in Common Routes of Drug Administration what is Route offers delivery closest to respiratory
tissues (ex: for asthma). Usually very rapid
absorption (ex: for anesthetic gases).

in Common Routes of Drug Administration what is The topical route includes application to the
skin or to the mucous membrane of the eye,
ear, nose, throat, airway, or vagina for local
effect

in Common Routes of Drug Administration what is The transdermal route involves application to
the skin for systemic effect. Absorption
usually occurs very slowly (because of the
thickness of the skin), but the first-pass
effect is avoided.

what catergory FDA Ratings of Drug Safety in Pregnancy is controlled studies in woman fail to
demonstrate a risk to the fetus in the first
trimester (and there is no evidence of a rish in
later trimesters), and the possibility of fetal harm
appears remote.

what catergory FDA Ratings of Drug Safety in Pregnancy is

what catergory FDA Ratings of Drug Safety in Pregnancy is either animal reproduction studies
have not demonstrated a fetal risk but there are
no controlled studies in pregnant women, or
animal reproduction studies have shown an
adverse effect (other than a decrease in fertility)
that was not confirmed in controlled studies in
women in the first trimester (and there is no
evidence of a rish in later trimesters

what catergory FDA Ratings of Drug Safety in Pregnancy is either studies in animals have
revealed
adverse
effects
on
the
fetus
(teratogenic or embryocidal or other) and there
are no controlled studies in women, or studies in
women and animals are not available. Drug
should be given only when the potential benefit
justifies the potential risk to the fetus

what catergory FDA Ratings of Drug Safety in Pregnancy is there is positive evidence of human
fetal risk, but the benefits from use in pregnant
women may be acceptable despite the rish (ex: if
the drug is needed in a life-threatening situation
or for a serious disease for which safer drugs
cannot be used or are ineffective

what catergory FDA Ratings of Drug Safety in Pregnancy is studies in animals or human beings
have demonstrated fetal abnormalities or there is
evidence
of
fetal
risk
based
on
human
experience or both, and the risk of the use of the
drug in pregnant women clearly outweighs any
possible benefit. The drug is contraindicated in
women who are or may become pregnant.