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Data
Lock.
At a predetermined time and date, in a clinical trial (in accordance
with the trial protocol) when the sponsor agrees they will
not submit anymore patient data to support their NDA (New
Drug Application). This date and time is called Data Lock.
Data
and Safety Monitoring Board (DSMB) board comprised of researchers
who periodically review data from blinded, placebo-controlled trials.
The researchers should be independent of the trials they are monitoring.
A DSMB board has the authority to stop a trial if the toxicities
are found or if the treatment is proved beneficial. These boards
are also known as Independent Data-Monitoring Committee.
De
novo design is the design of bioactive compounds
by incremental construction of a ligand model within a model of
the receptor or enzyme active site, the structure of which is known
from X-ray or nuclear magnetic resonance (NMR) data.
Desensitization
of a receptor mediated response, refers to the termination or diminution
of the response despite continued or repeated application of the
ligand.
Dipole
results in molecules that carry no net charge yet, have
a permanent charge separation due to the differences in the electronegativity
of the atoms that compose it. Dipole moment is a vector that quantifies
the resulting magnitude and direction of the charge asymmetry in
a dipole.
Dispersion
Forces (London Forces) are forces induced between neutral
molecules by induced dipole-induced dipole interactions. These forces
fall off very rapidly with distance, but can be significant in molecules
in close proximity.
Dipole-Dipole
Interactions are electrostatic interactions that occur
when molecules with permanent dipoles interact.
Distomer
is the enantiomer of a chiral compound that is the less potent for
a particular action. This definition does not excude the possibility
of other effect or side effect of the distomer (See also Eutomer).
Docking
studies are molecular modeling studies aiming at finding
a proper fit between a ligand and its binding site.
Dose-Escalation
is a preliminary study in a clinical trial in which the
amount of the drug is either periodically increased or increased
with each new trial arm that is added. Used to determine how a drug
is tolerated in people. Clinical Trial.
Double-blind
study is a clinical study of potential and marketed drugs,
where neither the investigators nor the subjects know which subjects
will be treated with the active principle and which ones will receive
a placebo.
Double
prodrug (or pro-prodrug) is a biologically inactive molecule,
which is transformed in vivo in two steps (enzymatically
and/or chemically) to the active species.
Drug
is any substance presented for treating, curing or preventing disease
in human beings or in animals. A drug may also be used for making
a medical diagnosis or for restoring, correcting, or modifying physiological
functions (e.g., the contraceptive pill).
Drug
disposition refers to all processes involved in the absorption,
distribution metabolism and excretion of drugs in a living organism.
Drug-Drug
Interaction refers to the effects that
occur when two or more drugs are used together. Such effects include
changes of absorption in the digestive tract, changes in rate of
the drugs. breakdown in the liver, new or enhanced side effects
and changes in the drugs. activity.
Drug
latentiation is the chemical modification of a biologically
active compound to form a new compound, which in vivo will
liberate the parent compound. Drug latentiation
is synonymous with prodrug design.
Drug
targeting is a strategy aiming at the delivery of a compound
to a particular tissue of the body.
Dual
action drug is a compound which combines two desired different
pharmacological actions at a similarly efficacious dose.
Dyspepsia
refers to a digestive upset, which may
include flatulence, heartburn, nausea or vomiting.
Dysphagia
relates to difficulty in swallowing.
Dysplasia
is abnormal changes or growth of cells
and tissues.
Dyspnea
is shortness of breath or difficulty in
breathing.
Edema
is the swelling caused by an abnormal accumulation of fluid
in body tissues.
Efficacy
describes the relative intensity with which agonists vary in the
response they produce even when they occupy the same number of receptors
and with the same affinity. Efficacy is the property that enables
drugs to produce responses. It is convenient to differentiate the
properties of drugs into two groups, those that cause them to associate
with the receptors (affinity) and those that produce stimulus (Efficacy).
This term is often used to characterize the level of maximal responses
induced by agonists. In fact, not all agonists of a receptor are
capable of inducing identical levels of maximal responses. Maximal
response depends on the efficiency of receptor coupling, i.e., from
the cascade of events, which, from the binding of the drug to the
receptor, leads to the observed biological effect.
Electrophoresis
is a phenomenon that results from the application of an electric
field causing a relative motion of the surface and diffuse layer;
the solvent is stationary and the particles move. The particles
must be large enough to have a double layer associated with them.
The velocity of the particles with respect to the field strength
is the electrophoretic mobility.
Elimination
is the process achieving the reduction of the concentration of a
xenobiotic including its metabolism.
Endocytosis
is the process of internalization of cell surface receptors or receptor
ligand complexes. Typically, receptor or receptor ligand internalization
is followed by dissociation and sorting in the endosome. The step
is either followed by degradation in the lysosome or by recycling
to the cell surface.
Enzyme
is a macromolecule, usually a protein, which functions as a (bio)
catalyst by increasing the reaction rate. In general, an enzyme
catalyzes only one reaction type (reaction selectivity) and operates
on only one type of substrate (substrate selectivity). Substrate
molecules are transformed at the same site (regioselectivity) and
only one or preferentially one of chiral a substrate or of a racemate
is transformed (enantioselectivity[special form of stereoselectivity]).
Enzyme
induction is the process whereby an (inducible) enzyme
is synthesized in response to a specific inducer molecule. The inducer
molecule (often a substrate that needs the catalytic activity of
the inducible enzyme for its metabolism) combines with a repressor
and thereby prevents the blocking of an operator by the repressor
leading to the translation of the gene for the enzyme.
Enzyme
repression is the mode by which the synthesis of an enzyme
is prevented by repressor molecules. In many cases, the end product
of a synthesis chain (e.g., an amino acid) acts as a feedback corepressor
by combining with an intracellular aporepressor protein, so that
this complex is able to block the function of an operator. As a
result, the whole operation is prevented from being transcribed
into mRNA, and the expression of all enzymes necessary for the synthesis
of the end product enzyme is abolished.
Eosinophil
is a type of granulocyte (see) thought
to play a role in fighting parasites producing allergic reactions.
Its name comes from these cells. absorption of the red dye eosin.
Erythrocyte
is a red blood cell. The primary function of erythrocytes
is to carry oxygen to cells.
Eudismic
ratio is the potency of the eutomer relative to that of
the distomer.
Eutomer
is the enantiomer of a chiral compound that is the more potent for
a particular action.
Expanded
Access refers to the FDA procedures (compassionate use,
parallel track and treatment IND see) that distribute experimental
drugs to patients who are failing on currently available treatments
for their condition and also are unable to participate in ongoing
clinical trials.
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