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’! see functional food.
health expenditures ’! see health care costs.
health profile Instrument for measuring quality of life, often over-
lapping with quality of life scale, well-being scale; health
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profiles are designed for a wide variety of conditions and can be
used to compare the effects of interventions in different diseases;
examples for h.p.s are: Sickness Impact Profile, McMaster Health
Index, Nottingham Health Profile, Hamilton s rating scale for
anxiety states, Taylor s Manifest Anxiety Scale, Eysenck Personal-
ity Inventory (measuring whether or not a subject has a neurotic
personality), a.s.o.
health-related quality of life (HRQOL) Narrower term than quality
of life; it includes that well being of a patient is influenced also by
factors unrelated to disease or treatment e.g. education, environ-
ment a.s.o.
health utilities index (HUI) Index for classification of the health sta-
tus of an individual; attributes to this index are: seeing, hearing,
hea
speaking, walking, use of fingers and hands, feelings, memory and
thinking, and pain and discomfort; ’! see also quality of life.
healthy-year equivalent (HYE) ’! see quality adjusted life year.
Heaton Ward effect Subjective assessments can be severely biased
by violation of blinding or the expectation of the observer: in a
supposed cross-over trial the observer is likely to report a dete-
rioration after cross-over if he initially assumed an improvement
and an improvement in those he first imagined had not occurred;
’! see also bias, blinding, design.
heart insufficiency score ’! see New York Heart Association.
Helsinki declaration ’! see declaration of helsinki.
herbal medicines ’! see phytomedicines, traditional herbal
medicinal product.
heterocygote Different alleles at a specific locus; ’! see also homo-
cygote.
high level term ’! see WHO adverse reaction terminology.
high-tech medicinal products EC (I): A): medicinal products de-
veloped by means of the following biotechnological processes: (1)
recombinant DNA technology, (2) controlled expression of genes
coding for biologically active proteins in prokaryotes and eukary-
otes, including transformed mammalian cells, (3) hybridoma
and monoclonal antibody methods; B): other high-technology
medicinal products: (1) other biotechnological processes which,
in the opinion of the competent authority concerned, constitute
a significant innovation, (2) medicinal products ad-ministered by
means of new delivery systems which, in the opinion of the com-
petent authority concerned, constitute a significant innovation,
(3) medicinal products containing a new substance or an entirely
new indication which, in the opinion of the competent authority
concerned, is of significant therapeutic interest, (4) new medici-
nal products based on radio-isotopes which, in the opinion of the
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competent authority concerned, are of significant therapeutic in-
terest, (5) medicinal products the manufacture of which employs
processes which, in the opinion of the competent authority con-
cerned, demonstrate a significant technical advance such as two-
dimensional electrophoresis under micro-gravity ; ’! see also
centralised procedure.
high-tech procedure ’! see centralised procedure.
historical control Group of patients who had received often within
the same organisation a standard treatment in the past and with
which a new treatment is compared; in literature controls this
group is made up of patients treated elsewhere and previously
reported in the medical literature; conclusions made from com-
parisons with h.c. however may be subject to severe bias due to
hyg
differences in patient selection, diagnostic techniques, environ-
mental conditions a.s.o.; ’! see also bias, control, minimization,
matched pairs.
Hochberg correction In order to avoid errors by repeated signifi-
cance testing the significance level is divided by the number of
comparisons; ’! see also Bonferroni correction.
home based CRA ’! see clinical research associate.
homocygote Identical allels at a specific locus; ’! see also hetero-
cygote.
hospital file ’! see patient file.
Huriet ’! see loi huriet.
hybrid procedure Submission of additional documentation in the
form of certain pharmacological or toxicological tests or clinical
trials by an applicant in order to demonstrate that his product is
essentially similar to the reference product does not preclude an
abridged application procedure.
Hygiene program procedures relating to health, hygiene and cloth-
ing of personnel during manufacturing; ’! see good manufac-
turing practice, loi huriet.
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ICD-9 code International Classification of Diseases, 9th edition;
’! see code.
ICD-10 code International Classification of Diseases, 10th edition;
(free access: http://www.dimdi.de); ’! see code.
ideal body weight ’! see lorentz formula.
IEEE Standard 1062-1993 Standard on the Recommended practice
for software acquisition published by the Institute of Electrical
,
and Electronic Engineers; ’! see also iso standard 9000-3, in-
terrnational organization for standardization.
IFAPP ’! see international federation of pharmaceutical phy-
sicians.
IFPMA ’! see international federation of pharmaceutical
manufacturers association.
IFPMA code of pharmaceutical marketing practices Voluntary and
self-limiting regulations of the IFPMA member companies; prin-
icd
ciples of this code are e.g. that no public communication shall be
made with the intent of promoting a pharmaceutical product as
safe and effective for any use before the required approval of the
pharmaceutical product for marketing for such use is obtained ;
statements in promotional communications should be based
upon substantial scientific evidence or other responsible medi-
cal opinion ; promotional communications should have medi-
cal clearance or, where appropriate, clearance by the responsible
pharmacist, before their release ; ’! see also code of practice.
illness Subjective feeling of not feeling well or normal; i. can be con-
sidered at four different levels: disability, impairment, handicap
and pathology; ’! see also disease, health.
immediate release form (IR) opposite: slow release form; ’! see
controlled release form, formulation.
immune system The aggregation of cells, biological substances (such
as antibodies), and cellular activities that work together to provide
resistance to disease; ’! see also biological medicinal product,
biopharmaceutical, biotechnology, gene therapy.
immunity Nonsusceptibility to a disease or to the toxic effects of
antigenic material; active immunity is when the organism pro-
duces antibodies against a specific agent e.g. by exposition (natu-
ral acquired a.i.) or vaccination (artificially acquired a.i.); a. i. is
long lasting or even permanent in contrast to passive immunity is
short-term immunization usually by the injection of antibodies,
such as gamma globulin, that are not produced by the recipient s
cells. Naturally acquired passive immunity occurs during preg-
nancy, in which certain antibodies are passed from the maternal
into the foetal bloodstream; cell-mediated immunity is an immune
response that does not involve antibodies or complement but
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rather involves the activation of macrophages, natural killer cells
(NK), antigen-specific cytotoxic T-lymphocytes, and the release of
various cytokines in response to an antigen; humoral immunity is
mediated by secreted antibodies (as opposed to cell-mediated im-
munity which involves T lymphocytes) produced in the cells of the
B lymphocyte lineage (B cell). Secreted antibodies bind to antigens
on the surfaces of invading microbes (such as viruses or bacteria),
which flags them for destruction.
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