ISSN 2277 - 3681
Indexing & Listing
Impact Factor-2.633
(JIF-2015)
Journal of
Pharmaceutical Science and Bioscientific Research
Volume 9
Issue 1, February 2019
Recent Trends in Effective Extraction Techniques of Bioanalytical
Sample Preparation
Minakshi Dhoru*, Kinnari Prajapati , Pinak Patel , Krunal Detholia
A Comparative Review on Bioanalytical Method Validation as per
Various Regulatory Guidelines
Minakshi Dhoru*, Kajal Shah, Pinak Patel, Krunal Detholia
Genotoxicity of Drugs: Introduction, Prediction and Evaluation
Sagar Kishor Savale*
A Review: Generic Drug Prescription
Binny Mehta*, Hemangini Sangale, Pinak Patel, Mr Krunal Detholia
ABSTRACT:
This
review
article
is
giving
an
idea
regarding
the
newer
recent
and
advanced
extraction
techniques
for
sample
preparation
in
bioanalysis.In
sample
preparation
Liquid-Liquid
extraction
(LLE),
Solid
phase
extraction
(SPE)
and
Protein
Precipitation
technique
(PPT)
is
well
known
method.
There
are
more
and
rapid
developments
of
novel
sample
preparation
techniques
in
bioanalysis.
In
SPE
techniques
there
is
area
of
solid-phase
microextraction
(SPME)
and
its
different
versions
are
available.
Techniques
such
as
dispersive
solid-phase
extraction,
disposable
pipette
extraction,
molecularly
imprinted
polymer
SPE
and
micro-extraction
by
packed
sorbent
offer
a
kind
of
extraction
phases
and
gives
unique
advantages
to
bioanalytical
methods.
On-line
SPE
using
column-switching
techniques
is
rapidly
gaining
acceptance
in
bioanalytical
applications.
Newer
approaches
to
conventional
LLE
techniques
like
salting
out
LLE
and
supported
liquid
techniques
are
also
covered
in
this
review article and also super critical fluid techniques is covered in it.
KEY
WORDS:
Bioanalysis,
Sample
preparation,
Solid
phase
micro-extraction,
Molecular
imprinting
solid
phase
extraction,
super critical fluid techniques.
![[x]](JPSBR_Vol_9_Issue_1_htm_files/close.png "Close")
ABSTRACT:
Bio-analysis
is
a
sub-discipline
of
analytical
chemistry
for
quantitative
measurement
of
drug
and
their
metabolite
in
biological
fluids.
Before
using
any
method
in
routine
use
validation
should
be
carried
out.
There
are
various
different
regulatory
guidelines
on
Bioanalytical
method
validation,
US
FDA
guideline
comes
into
effect
in
2001
for
Bioanalytical
Method
Validation
that
Provide
Guidance
for
Industry
and
is
accepted
universally
by
Pharma-
industries
and
research
organisation.
MHLW
and
EMA
also
come
in
account
with
US
FDA
guideline.
Recently
USFDA
released
a
new
draft
on
bioanalytical
method
validation
in
May
2018.The
present
review
include
a
discussion
on
evaluation
of
several
validation
parameters
such
as
sensitivity/selectivity, accuracy, precision, recovery specificity, calibration curve various stability analysis.
KEY WORDS:
Bioanalysis, Validation, USFDA, MHLW, EMA, Regulatory guidance.
Manuscript Rejected due to plegiarized content
ABSTRACT:
Generic
medicines
are
the
copy
of
brand
medicine
having
same
or
deliberate
changes
in
active
pharmaceutical
ingredient
as
well
as
other
content.
Generic
medicines
has
same
mode
of
action
as
that
of
brand
medicine
for
curing
respective
disease
or
disorder.
As
we
know
brand
medicine
more
costly
as
compare
to
their
generic
competitor.
Generic
medicines
should
be
studied
first
for
their
bio
equivalency
with
brand
medicine before they are prescribed. The possible impacts over the Pharmaceutical Sector should be examined.
KEY WORDS:
Generic Drugs, Brand name, Prescription, Pharmaceutical Sector
