Data Analysis in Preclinical Developement
Data Analysis in Preclinical Developement
Data Analysis in Preclinical Developement
in Preclinical Developement
Chapter 6
Computers play a significant role in preclinical
development.
Computers help a lot in data analysis.
Preclinical Development refers to development of
adequate data, facts and figures to ensure that a
particular drug is safe for human use.
Main purpose of preclinical studies is to determine
first safe dose of upcoming drug or medicine for
human use.
Before any drug is tested on humans, a lot of
experiments are conducted on animals to ensure that
the treatment goes well as per expectation and
outcome is generated.
Only then drug is declared safe for human testing.
All the data related to a drug, its existence, use, safety,
dosage, outcome, interactions, pharmacological effect,
preclinical effect, preclinical testing methods, FDA
approval, safety measures, adverse effects, overdose etc
are considered well before the launch .
This crucial information is entered and stored in
computers that can be further analyzed as and when
required by scientists, pharmacists, physicians and
other healthcare professionals.
Role of Computers in Preclinical
Development
Act as a store house of Drug information
Aids in study of toxicity and risk
management
Helps to develop predictive models for
better decisions
Makes pharmaceutical development more
efficient
Role of Computers in Preclinical
Development
Ensures collection and management
of clinical data.
Aids in better medical decision
making.
Improves quality of healthcare
management.
Uses of Computers in clinical Education
Multimedia: it refers to present
information in formats other than
text only. E.g. Sounds, Images,
Graphics, animations, Videos.
Computers help in great deal in
pharmacy training and education.
Uses of Computers in clinical Education
X- Rays, Electrocardiograms and other
interpretations and values with reference to
cases can be shown on multimedia and
taught to the students.
E- books, websites and wikipedia are also a
great source of help for the clinical
pharmacists and students to gather
information and data.
Uses of Computers in clinical Education
Computer simulations are helpful
in teaching techniques i.e
Demonstration of complete
physiological or pharmacological
process.
Chromatographic Data Analysis
It refers to software that simplifies entire
workflow process and saves a lot of time and
energy.
It gives better and faster results.
This Software is used to collect and analyze
Chromatographic Results i.e. techniques
used to separate mixtures in a laboratory.
Cont.
Thus it is related to effective workflow
within a laboratory.
It also can refers to as a workstation
that controls all the instruments
present in a laboratory.
It represents an integrated system with
all the saved in a central server.
CDS Products:
Chromeleon 7.2 CDS Software: It is used to
simplify lab workflow with unified control
for effective data management.
Laboratory Information management
System: manages all workflow within a
laboratory. It reduces implementation.
Training and validation costs of an
organization.
CDS Products:
Scientific Data Management System:
SECURELY SHARES data across multiple
users in an organization.
Integrated solutions: Provides most
effective lab data by integrating instruments
and software.
Importance of CDS
It can judged from the fact that high
performance liquid chromatography
(HPLC) and Gas Chromatography play an
important role in pharmaceutical analysis.
Research and Development in
Pharmaceutical companies is almost
impossible without these two types of
chromatography.
LIMS
Laboratory information management
system : refers to a software based data
management system that supports all
modern laboratory operations. LIMS
form an important part of data
management systems used in
preclinical development.
LIMS
LIMS were designed to automate major
parts of development like sample
tracking, sample distribution, work
assignment, result capturing, data
processing, data review, report
generation, and data sharing.
Thus LIMS fastened the process of
management in preclinical development.
Applications of LIMS
Sample management
Instrument and application
Integration.
Electronic Data Exchange.
Report Generation.
Inventory Management.
Benefits of LIMS
Thus, LIMS provides full
application functionality through a
web browser to ensure generation
of reliable and accurate results with
high speed and low maintenance
costs.
Benefits LIMS
Fast reports
Reduction in paper work
Improved efficiency
Improved data quality
Reduced errors
Avoids duplicacy
Simple formulas for calculation
Better integration with other departments
TIMS
Text Information Management System
Refers to collection and management
of text information from one or more
sources that can be shared with
different users at the right time and
right place.
TIMS
Information is entered, processed and
stored in the computer and later on,
can be used as per requirement.
The information can be stored in any
format like images, Videos, audios,
messages, texts, numbers etc.
TIMS
TIMS is a type of database
management system which
supports an access methods based
on both Select and search query.
It is mainly used by scientists a
report template.
Benefits of TIMS
Saves time and energy.
Faster method of report generation.
Ensures accuracy.
Improves efficiency in managing critical data.
Reduces paper work
Strict Security
Smooth and Easy workflow.
TIMS
TIMS is one step towards
encouraging the process of writing,
reviewing, auditing, approving and
publishing pharmaceutical text
reports .
Thank you