Computers as data analysis in Preclinical development: Chromatographic dada analysis(CDS), Laboratory Information management System (LIMS) and Text Information Management System(TIMS)

1. Computers as Data Analysis in
Preclinical Development
- MISS. VEDIKA NARVEKAR
M.PHARM

2. INTRODUCTION
 Pre-clinical development
It mainly includes the testing of a prospective drug on experimental animals to determine its
safety and dose that can be further used in humans.
Before any drug is tested on humans, a lot of experiments are conducted on animals to ensure
that the drug is safe for human use. All the data related to drug and its existence, use, safety,
dosage, FDA approval etc. are considered before the launch of any product in the market.
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.

3. How computers help in Pre- clinical
Development?
 Computers in preclinical development has become fundamental part of pharmaceutical
R&D for generating, Managing and transmitting information.
 Successful utilization of computers thereby increases the efficiency and productivity of the
development.
 Most of the data generated in preclinical development is managed using three computer
based systems.
 Chromatographic data analysis systems (CDS)
 Laboratory Information Management Systems (LIMS)
 Text Information Management Systems (TIMS)

4. Role of computers in pre-clinical
development
 Acts as a storehouse of drug information
 Aids in study of toxicological and risk assessment
 Helps to develop predictive models for better decisions
 Makes pharmaceutical development more efficient
 Ensures collection and management of clinical data
 Aids in better medical decision making

5. Chromatographic Data Analysis/ System
(CDS)
 Chromatography is mainly concerned with separation and identification technique.
Separation is based on the relative ability of components to adsorb or partition between
mobile phase and stationary phase.
 Chromatography is an analytical technique used in all sectors of pharmaceutical, medical
device and biotechnology industries to detect or quantify compounds during the course of
product development and manufacture.
 CDS refers to software that simplifies entire workflow process and saves lot of time and
energy. It gives better and faster results. This software is used to collect and analyze
chromatographic results i.e. technique used in labs to separate mixtures.
 CDS is thus referred as a “workstation” that controls all instruments present in lab.

6. CDS PRODUCTS
Some of the well known CDS products are as follows,
1. Chromeleon 7.2 CDS Software: It is used to simplify lab workflow with a unified control
for effective data management.
2. Laboratory Information Management System: Manages all workflow within a
laboratory., thereby reduces implementation, training and validation cost of an
organization.
3. Scientific Data Management System: Securely shares data across multiple users in an
organization.
4. Integrated Solutions: Provides most effective lab by integrating instruments and software.
CDS plays an important role in HPLC & GC.
Without CDS, R&D Sectors are impossible!!!

7. Laboratory Information Management Systems
(LIMS)
 Laboratory Information Management Systems refers to software based data management
system that supports all modern laboratory operations.
 LIMS form an important part of Data Management Systems used in Pre clinical
development.
 LIMS were designed to automate major parts of development like sample tracking, sample
distribution, work assignment, result capturing, report generation etc.
 Thus LIMS has fastened the process of management in Pre clinical development.

8. Applications of LIMS
1. Sample Management – the primary function of LIMS is management of samples received in the
laboratory. Barcodes are fixed to the sample containers in order to distinguish them from other
samples.
2. Instrument and Application Integration- an effective LIMS requires proper integration of
instruments and applications. This ensures accurate and effective result generation.
3. Electronic Data Exchange - LIMS provides real-time exchange with electronic health records used
in hospitals and clinical operators.
4. Report generation: LIMS is also responsible for effective report generation. Reports are generated
in the specified formats and scheduled time periods.
5. Inventory Management – It ensures management of all laboratory equipment.
Thus, LIMS provides full application functionality through a web browser. This ensures
generation of reliable and accurate results with high speed and low maintenance costs.

9. Benefits of LIMS
 Fast reports
 Reduction in paper work
 Improved efficiency and data quality
 Reduced errors
 Avoids duplicacy

10. Text Information Management System (TIMS)
 It 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.
 The information is entered, processed & stored in the computer and later can be used as per
requirement.
 The information can be stored in any format like images, videos, audio messages, text
numerical etc.
 It is mainly used by scientists as a report template to facilitate report writing. Once the draft
is ready, they can send electronic link of the document for review. Necessary changes are
done in the report and final auditing is done to convert the existing template into final
report. Thus TIMS saves a lot of time and energy.

11. Benefits of TIMS
 Saves time and energy
 Faster method of report generation
 Ensures accuracy
 Improves efficiency in managing critical data
 Reduced paper work
 Smooth and easy work flow
TIMS is one step towards writing, reviewing, auditing, approving and publishing the
pharmaceutical text reports in on go.
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