Journal of Pharmaceutical Research,
Год журнала:
2023,
Номер
8(2)
Опубликована: Июль 18, 2023
Regulatory
science
is
a
vital
component
of
pharmaceutical
development
and
approval
processes,
ensuring
the
safety,
efficacy,
quality
drugs.
This
article
provides
an
overview
background
importance
regulatory
in
industry.
It
highlights
critical
role
plays
supporting
innovation
creating
predictable
transparent
environment.
Recent
advances
are
discussed,
including
use
real-world
evidence,
innovative
trial
designs,
advancements
gene
cell
therapies.
These
developments
have
potential
to
revolutionize
drug
approval,
offering
new
treatment
options
improving
patient
outcomes.
However,
they
also
introduce
challenges
that
need
be
addressed,
such
as
reliability
evidence
adapting
complex
landscape
Understanding
evolving
field
crucial
for
professionals
navigate
bring
safe
effective
therapies
patients.
Frontiers in Health Services,
Год журнала:
2024,
Номер
3
Опубликована: Янв. 3, 2024
The
purpose
of
this
mixed
methods
feasibility
study
was
to
gain
insights
into
unmet
clinical
needs,
stakeholder
preferences
and
potential
barriers
enablers
adoption
for
planning
the
implementation
point-of-care
testing
earlier
detection
guided
treatment
chronic
obstructive
pulmonary
disease
(COPD)
acute
exacerbation
in
NHS
England.
Exacerbations
COPD
cause
considerable
mortality
morbidity.
Earlier
identification
exacerbations
would
lead
reduced
duration,
hospitalizations
mortality,
improve
health-related
quality
life,
reduce
unnecessary
treatments
(including
inappropriate
antibiotic
prescribing)
which
could
save
over
£400
per
patient.
During
early
stages
product
design,
we
took
a
multi-disciplinary
approach
evidence
generation,
gaining
from
key
stakeholders
test
concept
inform
evidence-based
planning.
Primary
data
collected
11
health
care
service
professionals
involved
management
exacerbations.
Overall,
participants
agreed
that
by
differentiation
stable
COPD,
patients
be
started
on
appropriate
treatment.
To
implement
practice,
is
required
demonstrate
accuracy
differentiating
between
etiologies
provide
information
beneficial
impact
system
terms
optimized
management,
long-term
side
effects,
admission
avoidance,
cost-effectiveness.
This
research
provides
an
base
future
exacerbation.
Moreover,
technology
developers
can
decide
whether
refine
design
value
proposition
thereby
de-risking
development.
Social pharmacy in health care,
Год журнала:
2024,
Номер
10(1), С. 11 - 20
Опубликована: Май 2, 2024
Aim.
To
study
modern
approaches
to
the
formation
and
functioning
of
Horizon
Scanning
(HS)
system
early
health
technology
assessment
(HTА),
in
particular,
for
treatment
rare
diseases
with
significant
unmet
medical
needs.
Materials
methods.
The
analysis,
systematization
synthesis
data
from
scientific
publications,
analytical
reports,
guidelines,
information
official
websites
regulatory
authorities,
HTА
HS
agencies
were
used.
Results.
analysis
theoretical
foundations
support
processes
forming
an
effective
at
stages
life
cycle
has
been
performed.
systems,
so-called
“early
awareness
alert
systems”,
are
aimed
identifying,
filtering
prioritizing
new
innovative
technologies
a
predicted
impact
on
health,
costs,
society
healthcare
order
inform
policy
makers,
purchasers
providers
or
improve
access.
allows
proactive
planning
decision-making
use
reimbursement
medicines
based
preliminary
assessments
budgetary
clinical
efficacy.
Conclusions.
For
national
HTA
system,
which
currently
is
stage
development,
it
important
adapt
positive
international
experience
this
area
provide
functionality
HS,
assessment,
dialogue,
managed
access
development
evidence
base.
It
advisable
apply
“light”
model
join
cooperation
area.
Frontiers in Microbiomes,
Год журнала:
2024,
Номер
3
Опубликована: Окт. 7, 2024
Immunotherapies
are
a
revolutionary
approach
to
treating
cancer
by
utilizing
the
body’s
immune
system
target
and
combat
cells.
This
offers
promising
alternatives
traditional
chemotherapies.
Its
potential
induce
long-lasting
remissions
specificity
for
cells,
which
minimizes
side
effects,
makes
it
cutting-edge
treatment
with
tremendous
potential.
With
increase
of
clinical
usage
immunotherapy,
evidence
emerges
microbiome’s
impact
on
both
tumor
growth
response
immunotherapy.
The
proposed
involvement
microbiome
can
change
efficacy
altering
drug
metabolism
reshaping
response.
Understanding
specific
interactions
between
is
critical
step
in
advancement
To
study
complex
interaction
immunity
microbiome,
various
preclinical
vivo
vitro
models
have
been
developed.
We
recently
described
use
an
ex
model
anti-cancer
outcome
prediction
–tumor
tissue
equivalents
(organoids).
Specifically,
immune-reactive
organoids
as
novel
tool
understanding
how
influences
More
importantly,
this
platform
utilize
patient
samples
dissect
patient-specific
elements
regulating
influence.
review
presents
rationale
using
It
will
discuss
available
components
analyze
their
interplay,
summarize
relevant
experimental
data,
assess
validity.
Additionally,
explores
personalized
approaches.
role
immunotherapy
outcomes
lead
transformative
via
simple
diet
or
other
manipulations.
Ongoing
research
microbiome-cancer
systems
innovative
strategies
improved
outcomes.
BACKGROUND
This
study
investigates
the
role
of
and
methods
for
patent
analysis
in
advancing
medical
technology
(MedTech)
innovation,
a
sector
characterized
by
diverse,
non-pharmacological
or
non-immunological
healthcare
technologies
significant
research
investment.
Patents
are
critical
early
indicators
supporting
horizon
scanning
weak
signal
detection.
OBJECTIVE
The
aimed
to
identify
intellectual
property
sources,
evaluate
retrieval
analysis,
outline
objectives
using
data
anticipate
trends
inform
strategies.
It
also
offered
methodological
framework
support
stakeholders
adopting
innovative
MedTech
solutions.
METHODS
A
rapid
review
(RR)
was
conducted
Cochrane
Rapid
Review
Methods
PRISMA
guidelines,
with
pre-registered
protocol
on
Open
Science
Framework.
Searches
Embase,
IEEE
Xplore,
Web
targeted
records
from
2020
onwards.
Three
independent
reviewers
screened
studies
Rayyan.
We
included
any
type,
published
since
that
provided
sufficient
tools
applied
MedTech.
Our
extraction
bibliographic
details,
characteristics,
information.
Risk
bias
assessments
were
not
undertaken.
Narrative
tabular
methods,
supplemented
visual
charts,
employed
synthesise
findings.
RESULTS
searches
identified
1,741
studies,
which
124
after
title,
abstract,
full-text
screening,
54%
being
original
research,
44%
reviews,
remainder
conference
abstracts.
Most
(68%)
relied
solely
databases,
while
others
searched
grey
literature.
Research
grouped
into
nine
themes,
trend
(50%)
policy
recommendations
(20%)
most
common.
analysed
199
27%
multiple
sources.
Time
horizons
averaged
24.6
years,
ranging
1900
2019.
Automated
approaches,
33%
frequently
utilised
like
Gephi
network
visualization.
Disease
mapping,
based
NICE
classification,
indicated
cancer
(19%)
respiratory
conditions
(16%),
particularly
COVID-19,
key
areas,
digital
health
dominated
"health
social
care
delivery"
category.
CONCLUSIONS
highlights
value
its
broader
shaping
policies
While
patents
provide
crucial
insights
emerging
technologies,
inconsistent
de-duplication
practices
across
pose
risk
inflation,
accentuating
need
transparency
rigour.
Finally,
this
emphasized
importance
transformation
visualization
detecting
Python
R
commonly
used
programming
languages
developing
custom
tools.
CLINICALTRIAL
N/A
Vaccines,
Год журнала:
2024,
Номер
12(12), С. 1436 - 1436
Опубликована: Дек. 20, 2024
The
concept
of
"platform
technology"
gained
prominence
after
the
Ebola
outbreak
and
since
then
has
become
essential
to
international
vaccine
(prophylactic
vaccines
against
infectious
disease)
regulatory
frameworks.
Its
significance
was
further
amplified
during
COVID-19
pandemic,
where
platform
technology
enabled
rapid
development
approval
vaccines,
optimizing
processes,
enhancing
global
public
health
responses.
As
a
transformative
tool,
streamlines
product
development,
allowing
for
reduction
in
number
clinical
trials
or
exemption
from
certain
facilitating
cross-referencing
submissions.
Despite
significant
efforts
establish
standardized
procedures,
challenges
remain,
particularly
achieving
unified
definition
application
across
regions.
This
paper
explores
evolution,
applications,
strategies
technology,
with
focus
on
China's
experience
this
field.
approach,
encompassing
risk
assessment,
expedited
emergency
offers
valuable
insights
into
coordination.
By
analyzing
contributions
practices,
highlights
potential
address
future
pandemics,
including
"Pathogen
X",
underscores
importance
harmonizing
strengthen
preparedness
response.
ScienceRise Pharmaceutical Science,
Год журнала:
2023,
Номер
4(44), С. 76 - 88
Опубликована: Авг. 31, 2023
The
aim:
development
of
methodological
approaches
to
assessing
the
digital
maturity
logistics
activity
a
pharmaceutical
enterprise
and
elaboration
proposed
methodology
on
example
those
domestic
enterprises
that
have
developed
system
some
experience
in
implementation
technologies
activities.
Materials
methods:
Research
was
conducted
using
databases
Internet:
European
Center
for
Information
Systems
Research,
Medicines
Agency,
scientific
metric
-
Scopus,
Web
Science.
Logical,
systematic
analysis
synthesis,
graphic
methods
research,
mathematical
statistical
(expert,
pair
correlation
taxonomic)
were
used.
results.
An
state
carried
out
enterprises,
which
been
leaders
market
recent
years.
It
is
substantiated
assessment
mandatory
prerequisite
transformation
entities.
existing
models
are
analyzed,
their
shortcomings
identified.
Based
this,
activities
proposed.
algorithm
practical
application
taxonomic
method,
calculation
integral
indicator
level
out.
priorities
determined
depending
degree
maturity.
Conclusions.
has
proven
complex
process
must
consider
many
factors
internal
external
environment
enterprise.
impossible
form
strategy
make
decisions
about
investing
without
first
your
real
opportunities
weak
points
That
why
an
important
step
way
digitalization
methodical
will
allow
holistic
view
certain
its
deviation
from
desired
state,
determine
priority
directions
increasing
maturity,
based
specifics
particular
enterprise,
develop
sound
improve
performance
both
individual
business
supply
chain
Pharmaceuticals
are
an
indispensable
tool
against
disease
and
morbidity
in
humans
animals.
However,
their
use
also
poses
some
challenges
can
lead
to
undesirable
consequences,
of
the
most
concerning
which
increased
environmental
pollution
antimicrobial
resistance.
The
assessment
human
health
risks
posed
by
pharmaceuticals
is
a
critical
exercise
help
make
best
available
knowledge
identify
data
gaps
prioritize
strategies
holding
promise.
goal
this
dissertation
was
assess
pharmaceutical
aquatic
system
via
exposure.
concentrations
activities
transboundary
European
Vecht
River
were
used
demonstrate
idea.
In
addition,
selective
pressure
potential
antibiotics
over
antibiotic-resistance
genes
investigated
artificial
natural
environments.
Taken
together,
we
how
risk
remains
resourceful
support
targeted
emission
exposure
reduction
(local)
responsible
authorities.
Using,
statistical
mathematical
modelling,
contributed
advancement
tailored
resistance
environment.
Journal of Pharmaceutical Research,
Год журнала:
2023,
Номер
8(2)
Опубликована: Июль 18, 2023
Regulatory
science
is
a
vital
component
of
pharmaceutical
development
and
approval
processes,
ensuring
the
safety,
efficacy,
quality
drugs.
This
article
provides
an
overview
background
importance
regulatory
in
industry.
It
highlights
critical
role
plays
supporting
innovation
creating
predictable
transparent
environment.
Recent
advances
are
discussed,
including
use
real-world
evidence,
innovative
trial
designs,
advancements
gene
cell
therapies.
These
developments
have
potential
to
revolutionize
drug
approval,
offering
new
treatment
options
improving
patient
outcomes.
However,
they
also
introduce
challenges
that
need
be
addressed,
such
as
reliability
evidence
adapting
complex
landscape
Understanding
evolving
field
crucial
for
professionals
navigate
bring
safe
effective
therapies
patients.
