Certain aspects of the methodology of conducting clinical trials of drugs for the treatment of Alzheimer’s disease
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice,
Год журнала:
2025,
Номер
1, С. 4 - 18
Опубликована: Март 31, 2025
Introduction.
Dementia
is
a
heterogeneous
class
of
diseases,
the
individual
subtypes
which
are
distinguished
based
on
etiological
factors,
nature
disorders,
course
dementia,
as
well
laboratory
instruments
and
neuroimaging.
Among
diseases
whose
leading
clinical
syndrome
Alzheimer's
disease
(AD),
vascular
dementia
with
Lewy
bodies,
Pick's
disease,
Creutzfeldt-Jakob
Huntington's
chorea,
Parkinson's
effects
traumatic
brain
injury,
tumor,
substance
abuse
other
diseases.
Currently,
there
no
treatment
that
could
significantly
slow
down
or
stop
AD
brain,
search
continues
for
ways
to
improve
AD.
The
effective
safety
drugs
an
extremely
important
task,
determines
urgency
developing
new
its
treatment.
Proper
program
planning
trials
necessary
obtain
reliable
data
efficacy
drugs.
documents
in
Russian
Federation
(RF)
Eurasian
Economic
Union
(EEU)
regulating
conduct
used
treat
Objective.
aim
this
study
was
analyze
regulatory
approaches
research
programs
abroad
assess
possibility
extrapolation
RF
practice
development
Discussion.
strategy
conducting
requirements
volume
quality
regarding
presented.
This
article
prepared
basis
recommendations
approved
by
medicines,
guidelines
examination
drugs,
EU
requirements,
from
International
Council
Harmonization
Technical
Requirements
Registration
Medicines
Medical
Use
(ICH).
Conclusion.
An
analysis
Guidelines
European
Agency
(EMA),
regulate
basic
principles
key
aspects
preclinical
AD,
carried
out.
provisions
EMA
can
be
drug
programmes
treating
It
advisable
develop
national
guideline
accordance
legal
acts
force
RF.
Язык: Английский
Pharmacopoeial standardisation of biological medicinal products: Basic principles for the common pharmaceutical market of the Eurasian Economic Union
Biological Products Prevention Diagnosis Treatment,
Год журнала:
2025,
Номер
25(1), С. 71 - 82
Опубликована: Март 10, 2025
INTRODUCTION.
The
advancement
of
manufacturing
technologies
and
the
expanding
range
biological
medicinal
products
(BMPs)
indications
for
their
use
necessitate
development
a
unified
approach
to
BMP
standardisation
at
both
national
regional
levels.
In
contextof
common
pharmaceutical
market
EAEU
(EAEU),
requirements
should
take
into
account
pharmacopoeial
quality
standards,
which,
in
turn,
are
subject
harmonisation
with
standards.
AIM.
This
study
aimed
systematise
BMPs
State
Pharmacopoeia
Russian
Federation
achieve
DISCUSSION.
analysed
special
considerations
accordance
pharmacopoeias
Member
States.
addition,
covered
major
international
regulatory
documents,
including
those
by
International
Council
Harmonisation
Technical
Requirements
Pharmaceuticals
Human
Use
(ICH).
Having
established
basic
principles
formulating
within
scope
EAEU,
authors
drafted
general
chapter
EAEU.
draft
introduced
uniform
definition
BMPs,
taking
legislation.
standardised
compendial
different
groups
highlighting
main
production
(technology)
control
intermediates
finished
products.
When
harmonising
outlined
approaches
applied
made
amendments
General
Chapter
1.7.1.0010.18
Biological
pharmacopoeia.
particular,
removed
that
were
not
universally
applicable
all
along
lists
mandatory
tests
active
substances
CONCLUSIONS.
systematised
documents.
used
it
updating
Federation.
also
substantiated
drafting
texts
(general
chapters
monographs)
BMPs.
Язык: Английский