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Digg It - Enterprise Content Management: Convergence of Structured & Unstructured Data Management
Enterprises are handling increasing amounts of unstructured data (electronic data that are not stored in a predefined structure, like office documents, e-ma
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
il, web info), frequently kept in repositories which have structures of limited efficiency & accessibility. Moreover the internal structure of files is usua
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ly not standardised and may not be efficient, in terms of information retrieval and reusability. According to international studies, more than 85% of busine
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s data are of unstructured nature.
The advent of web content and the necessity to use proactively the web channel in the market, has further increased the
The advent of web content and the necessity to use proactively the web channel in the market, has further increased the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
eed to efficiently manage information content of unstructured nature. The volume of information is rapidly increasing, thus becoming unmanageable (info glut
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
. The increasing need to handle business information efficiently, in a highly competitive environment, has driven business efforts to improve ways of storin
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
, retrieving, analyzing and reusing unstructured data. All relevant efforts aim to develop a meaningful structure which shall accommodate unstructured data.
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
In other words to convert unstructured data to semi-structured data: data having a higher degree of structure than the former (not using a highly granular
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tructure as data stored in fields of a relational database table, however not being stored in a loosely & ineffectively structured data repository).
Tradit
Tradit
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
onally, techniques & technologies used to handle structured data (DBMS, SQL) were incompatible to those used to handle unstructured data (file servers, cont
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nt management systems, collaboration tools). The term Business Intelligence stems from the structured world while the term Knowledge or Content management
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
tems from the unstructured world. The combined retrieval & analysis of information (e.g. for a Customer) from both structured & unstructured data, has been
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
raditionally carried out manually. However the term business intelligence does no longer refer exclusively to the structured data world. Convergence of str
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ctured & unstructured data technologies, is currently experienced. The introduction of a central data repository, can mitigate the negative effect caused by
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
the development of information silos. This applies to both structured and unstructured data assets.
In order to develop a structure for handling unstructu
In order to develop a structure for handling unstructu
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ed data, an information model needs to be developed. This model has to accommodate the needs of different user groups: customers, info users, content autho
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
s, while being structured meaningfully: e.g. per product line, per business process. The use of DTDs (Document Type Definition) or XML schemas to structure
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ontent internally by introducing semantic tags, can enhance the capability to retrieve and reuse information hidden in documents. The use of sitemaps, meta
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ags and RSS feeds has being expanding on the Web, to describe the content of sites, especially on content which is frequently being updated (e.g. news conte
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
t). RSS allows site syndication, an approach to share content on the web, thus increasing its accessibility & diffusion.
Copyright 2006 – Kostis Panayotaki
Copyright 2006 – Kostis Panayotaki
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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