Unit 5 Computers as data analysis in Preclinical

CHROMATOGRAPHIC DATA SYSTEMS (CDS) The chromatograms generated by these analytical methods are displayed, integrated

CHROMATOGRAPHIC DATA SYSTEMS (CDS) v The importance of CDS is directly related to the

TIMS – Text information Management System A TIMS is essential for preclinical Development because

Objectives of TIMS ü It is organize and store the large amount of text.

Need of TIMS ü TIMS also called as Textual Information Management System in literature.

Documentation requirements in preclinical development Several types of controlled text documents used in preclinical

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Unit - 5 Computers as data analysis in Preclinical development 1. CDS—chromatographic data systems 2. LIMS—laboratory information management systems 3. TIMS—text information management systems It is probably fair to say that these three computer systems handle the majority of the work in data/document management in the preclinical area, supporting the New Drug Application (NDA) & Marketing authorization application (MAA) filings.

CHROMATOGRAPHIC DATA SYSTEMS (CDS) The chromatograms generated by these analytical methods are displayed, integrated and results calculated by a software application called a CDS—chromatographic data systems is collects & analyzes chromatographic results.

CHROMATOGRAPHIC DATA SYSTEMS (CDS) v The importance of CDS is directly related to the roles that chromatography, particularly high-performance liquid chromatography (HPLC) and gas chromatography (GC), play in pharmaceutical analysis. v HPLC and GC are the main workhorses in pharmaceutical analysis. In today's pharmaceutical companies, development work cannot be done without HPLC and GC. v CDS are also used for several other instrumental analysis technologies such as ion (exchange) chromatography (IC), capillary electrophoresis (CE), and supercritical fluid chromatography (SFC).

TIMS – Text information Management System A TIMS is essential for preclinical Development because huge no of text documents and other related information such as images, photograph etc. . It has helped in pharmaceutical industry to improve efficiency in managing text documents.

Objectives of TIMS ü It is organize and store the large amount of text. ü It help the preclinical Development.

Need of TIMS ü TIMS also called as Textual Information Management System in literature. ü These System deals various kind of documents which are textual in nature.

Documentation requirements in preclinical development Several types of controlled text documents used in preclinical development. ü SOP’s – Standard operating System ü Research records ü Laboratory Notebook ü Product specification documents and analytical test method.