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ment.
pharmaceutical medicine IFAPP: Medical scientific discipline con-
cerned with the discovery, development, evaluation, registration,
monitoring, and medical aspects of marketing of medicines for the
benefit of patients and the public health
.
pharmaceutical quality assurance EC: the sum total of the orga-
nized arrangements made with the object of ensuring that medici-
nal products are of the quality required for their intended use ;
’! see also quality assurance.
pharmacodynamic Science dealing with the (pharmacologic) mech-
anism of drug action once it reaches the target organ(s); (relation-
ships between the concentration of a drug at its site(s) of action
and the magnitude of the biological or physiological effect that is
achieved); primary ph. studies are studies on the mode of action
and/or effects of a substance in relation to its desired therapeutic
target (in contrast to secondary ph. studies).
pharmacoeconomic study ’! see economic analysis.
pharmacoepidemiology Science of systematic or observational
studies of drug effects in populations receiving the drug through
usual clinical practice; objectives are, e.g., to detect unrecognised
risks especially after long term administration and under widening
conditions of use; p. includes the following main types of studies:
pha
prescription (utilisation) studies, which verify to what extent clini-
cians follow official recommendations and therapeutic indications
stated e.g. by summaries of product characteristics for doc-
tors; studies on the therapeutic benefit, and studies of risk dealing
with two main aspects: identification of events, and imputability
of specific effects to the use of a given drug (still taking into ac-
count effects and interactions which might have been caused by
concomitant treatments as well as by the natural course of dis-
eases as e.g. concerning exposure, outcome, bias, confounding,
generalizability, statistical stability a.s.o.); classical methods are:
case-control-, cohort-, cross-sectional studies; ’! see also
post-marketing-surveillance.
pharmacogenetics Science studying genetic response to a drug and
people with unusual metabolism; ’! see also ethnic differenc-
es, metabolism, pharmacogenomics, single nucleotide poly-
morphism.
pharmacogenomics The identification of the genes that influence
individual variation in the efficacy or toxicity of therapeutic agents,
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and the application of this information in clinical practice; science
studying genetic basis for diseases such as the correlation between
genes, phenotypes and diseases; currently only the function of
about 2,000 genes is known out of the potential of 100,000; ’! see
also ethnic differences, gene therapy, genomics, metabo-
lism, pharmacogenetics.
pharmacokinetic Science dealing with the absorption, distribution,
metabolism, and excretion (adme) of drugs in the body, usually
conducted as single dose studies or steady state study; popula-
tion pharmacokinetics takes into account that drugs behave differ-
ently in different populations, e.g children or old persons; ’! see
also area under the curve, bioavailability, clearance, first-
pass effect, half life, kinetic, partition coefficient, protein
binding, volume of distribution.
pharmacokinetically guided dose escalations (PGDE) Dose esca-
lation strategy in phase I oncological trials; it is based on the hy-
pothesis that the area under the plasma concentration-time curve
(AUC) at the LD-10 in mice and at the MTD in man are similar (pa-
tient s AUCs must be measured and be available rapidly); ’! see
also continuous reassessment method (CRM), dose escala-
tion, fibonacci search scheme, maximum tolerated systemic
exposure (mtse).
pharmacology Science dealing with effects of a drug on organs or
body systems; this covers the mutual interaction of chemical
agents and biological systems, the nature of the action (i.e., the
nature of the altered bodily response), the site of action, and the
pha
mechanism involved.
pharmacopoeia Regularly updated information on drugs in book
form (standards of quality specifications such as purity, iden-
tity a.s.o.); quality of commercialized medicinal products must
comply with these standards; examples: British P., British Ho-
moeopathic P., US P., European P; the European P. has been elabo-
rated by over 20 European countries including Member States of
the European Community and has binding character, reinforced
by EC directives.
pharmacovigilance Def.: science and activities relating to the de-
tection, assessment, understanding, and prevention of adverse
effects or any other drug related problems (WHO); the process
of monitoring, evaluating and improving the safety of medicines
in use (EMEA); confounded sometimes with post-marketing
surveillance; system for collecting spontaneous reports on
adverse reactions, assessing causality and risks; major meth-
ods are: spontaneous, voluntary reporting schemes (e.g. yellow
card system), intensive hospital monitoring, use of official statis-
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tics and observational, non-experimental studies such as case-
controlled studies, cohort studies, prescription-event
monitoring, prescription sequence analysis; adverse reaction
frequencies are expressed as cases per treatment or per month of
treatment sold or per prescriptions; knowledge of drug sales is es-
sential; although spontaneous reporting is the most commonly
used method, whereby either the physician reports to the health
authority (common in e.g. Austria, France, Italy) or the pharma-
ceutical company (Germany, USA); one of the major drawbacks is
underreporting of events, causing underestimation, loss of statis-
tical power and therefore erroneous conclusions; in some coun-
tries (e.g. France) a combined system of spontaneous reporting
and semi-intensive hospital surveillance with regional centres is
in use; ’! see also data mining, drug safety monitoring, post-
marketing surveillance, safety officer, yellow card.
pharmacy dispensing records List of experimental drugs dis-
pensed by and returned to a pharmacy during a clinical trial;
’! see also drug accountability.
pharmacy drug (P) Drug which can only be sold over the counter un-
der the supervision of a pharmacist (UK); ’! see also controlled
drug, general sale list medicine, gras-list, prescription
only medicines, over-the-counter.
phase I First trials during clinical development of a new active in-
gredient in man, often in healthy volunteers; the purpose is to
establish a preliminary evaluation of safety and a first outline of
the pharmacokinetic/-dynamic profile of the active ingredient in
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humans, associated with increasing doses (usually until an acute
effect dose is reached), to permit the design of well-controlled,
scientifically valid phase II studies; the total number of subjects is
generally in the range of 20 to 80, the mean development time 16
months (1987); commonly used target doses in phase I trials are
e.g. 1/3 of the toxic dose level (TDL) in the most sensitive large
animal species, or 1/10 of the LD-10 (mg/m2) in the mouse and 1/3
of the TDL in dogs, or 1/3 of the LD-10 in mice; ’! see also adme,
dose escalation, fibonacci search scheme, latin square de-
sign.
phase II Therapeutic pilot studies; the purpose is to demonstrate
biologic activity (often called phase IIa or early phase II) and later
therapeutic effects (phase IIb, late phase II), in addition to short-
term safety, of the active ingredient in patients suffering from a
disease or condition for which the active ingredient is intended;
the trials are performed in a limited number of subjects, usually
some hundreds, and often, at a later stage, in a comparative (e.g.
placebo controlled) design; this phase also aims at the deter-
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